A Prospective Study to Evaluate the Safety and Performance of PICO 14 in the Management of Acute and Chronic Wounds
Conditions: Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg, Pressure Ulcer, Wound Dehiscence
Sponsor: Smith & Nephew, Inc.

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 1 of 131
CONFIDENTIAL AND PROPRIETARY
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is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
Sponsor Name and
Address:
T. J. Smith & Nephew Ltd., 101 Hessle Rd, Hull, HU3 
2BN, UK
Investigational Product(s)
PICO 14 
Protocol Author(s):
Samia Shah – Snr Clinical Study Manager
Michelle Foster – Clinical Study Statistician 
Brian Gilchrist – Clinical Strategy Lead

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 4 of 131
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is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
SPONSOR APPROVAL.
Job title
DocuSign Stamp
Head of Global Clinical 
Operations
Head of Global Clinical 
Strategy
Head of Global 
Biostatistics
Medical Affairs 
Representative
Global Clinical 
Global Clinical

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 5 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and 
is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
SYNOPSIS.
Title of Study:
A prospective study to evaluate the safety and performance of 
PICO 14 in the management of acute and chronic wounds.
Study Design:
Prospective
Multi-centre
Non-randomised
Study Type:
Prospective, non-random, non-blinded case series.
Study Product: 
PICO 14.
Comparison 
Group(s)*:
(*if applicable)
There is no comparison group in this study.
Study Purpose:
To generate evidence of the safe and effective use of the device in 
the management of chronic open wounds (pressure ulcers, venous 
leg ulcers, diabetes-related foot ulcers), dehisced surgical wounds 
and closed surgical incisions. 
The study comprises the PMCF for a new variant of an established 
product.
Primary Objective:
To assess the functional performance of PICO 14 through 
verification of delivery of negative pressure and wound exudate 
management. 
Secondary 
Objective(s):
Closed incisions ONLY :
To assess clinical performance and safety of the PICO 14 NPWT 
system within 30 days of surgery through:
Incidence of Surgical Site Infection (SSI) – Superficial, 
deep. [CDC criteria].
Incidence of Surgical site Complications (SSC) [as 
applicable: dehiscence (superficial/deep etc.), seroma, 
necrosis, hematoma, suture abscess].
Condition of peri-wound skin assessed through visual 
inspection at 7, 14 and 30 days.
Patient tolerability assessed by level of pain and level of 
satisfaction.
Clinician acceptability assessed by ease of application and 
removal.
Dressing wear time, dressing change frequency and 
conformability will be assessed.
Scar quality measured by Patient and Observer Scar 
Assessment Scale (POSAS) score.

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 6 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and 
is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
Chronic Wounds and dehisced wound ONLY:
To assess clinical performance and safety of the PICO 14 NPWT 
system within 28 days therapy period through:
Incidence of infection.
Dressing wear time, dressing change frequency and 
conformability will be assessed.
Wound assessment:
o
Appearance of the wound.
o
Condition of peri-wound skin.
o
Level of exudate.
o
Wound pain.
o
Size of wound (percentage reduction in area, depth, 
and volume).
Patient tolerability assessed by level of pain and level of 
satisfaction.
Clinician acceptability assessed by ease of application and 
removal.
Other Objective(s):
No other objectives.
Statistical Rationale: 
Data extracted from a PICO sample device showed that the mean 
operating pressure was -80.2mmHg (SD=14.8). It is assumed that 
all the PICO 14 pumps will have a similar mean operating 
pressure. Based on these assumptions 55 subjects are required to 
achieve 80% power to detect equivalence within a 6mmHg margin, 
-tests 
(TOST). It is expected that approximately 20% of the subjects may 
be lost to follow up by the end of the study and so to account for this 
70 subjects will be recruited into the study.
Sample Size:
The study will include 70 patients. There will be a minimum of 10 of 
each of the following wound type; venous leg ulcers, diabetes-
related foot ulcers, pressure ulcers, dehisced surgical wounds and 
post-operative incisions.
Number of Study Sites: Up to ten. 
Targeted Global 
Regions
US, Canada, UK and Europe.

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 7 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and 
is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
Inclusion Criteria:
The subject must provide written informed consent.
Subjects eighteen (18) years of age or older.
Willing and able to make all required study visits.
Able to follow instructions.
Subject is suitable to participate in the study in the opinion 
of the Investigator.
Closed Incisions ONLY:
Subject has a suitable, closed surgical incision which the 
clinician considers is suitable for PICO therapy, where it is 
expected that the therapy will be applied for up to 14 days.
Any closed surgical incision in a patient in which the patient 
is deemed high risk of developing SSI in the opinion of the 
investigator.
Chronic wounds ONLY: 
Patients with any chronic wound* which the treating clinician 
deems is suitable for management with single-use 
disposable NPWT where it is expected that the therapy will 
applied for up to  28 days.
*Chronic wound in this study is defined as any wound of less than 
three months duration that is not healing after 4 weeks of 
standard care and having addressed the underlying cause.
Dehisced surgical wounds ONLY:
Patients with dehisced wounds in which the clinician 
believes is suitable for PICO therapy where therapy is 
expected to be applied for up to 28 days.
*Wound dehiscence is a surgical complication in which two 
sides of a surgical incision separate and rupture along the 
incision, dehiscence typically is diagnosed after 2-3 days post-
surgery and up to a month with more complicated surgeries (58).
Please note the pathway to recruiting participants with 
dehisced wounds has changed to widen the recruitment reach. 
This does mean that participants seen in the community for 
dehisced wound will be eligible to join study, the sites will be 
able to screen for participants using both pathways, whether 
seen in clinic by surgeon in charge or in the community.

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 8 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and 
is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
Exclusion Criteria:
Contraindications (per the PICO 14 IFU) or hypersensitivity 
to the use of the investigational product or their components 
(e.g. silicone adhesives and polyurethane films [direct 
contact with incision], acrylic adhesives [direct contact with 
skin], polyethylene fabrics and super-absorbent powders 
[polyacrylates]) within the dressing).
Subjects who require the use of SECURA non-sting barrier 
skin wipes and have hypersensitivity to the ingredients in the 
wipes.
Participation in the treatment period of another clinical trial 
within thirty (30) days of operative visit or during the study.
Subjects with skin features (e.g. tattoos, skin colour, pre-
existing scarring) which in the opinion of the Investigator, will 
interfere with the study assessments.
Patients undergoing a procedure as part of palliative care (to 
be confirmed during surgery).
Subjects who have participated previously in this clinical trial 
Subjects with a history of poor compliance with medical 
treatment.
Malignant wounds, open abdomen, wounds which have 
been previously managed with NPWT in the previous four 
weeks. 
Pregnancy.
Subjects with a medical or physical condition that, in the 
opinion of the Investigator, would preclude safe subject 
participation in the study.
Presence of infection as determined by the clinical signs and 
symptoms (International wound infection59).
Study Duration:
It is anticipated that enrolment will take 18 months.
Primary endpoint:
Functional clinical performance of the PICO 14 NPWT system over 
the treatment period to include: 
Delivery of -80mmHg negative pressure to the wound bed 
over the treatment period. This will be measured by 
download of the built-in data chip from the PICO 14 devices 
to collect NPWT delivery status.
Exudate management assessed by no occurrence of 
exudate leaks during the treatment period resulting, or not, 
in an unplanned dressing change.

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 9 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and 
is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
Secondary endpoint(s):
Closed Incisions Only:
Clinical performance and safety of the PICO 14 NPWT system over 
a 14 day therapy and 30 day follow-up period to include:
Scar quality measured by POSAS score at Day 14, and day 
30.
Incidence of Surgical Site Infection (SSI) and incidence of 
Surgical Site Complication (SSC) within 30 days of surgery 
[CDC criteria].
Condition of peri-wound skin assessed through visual 
inspection at 7, 14 and 30 days.
Level of pain on application, during wear and at dressing 
removal assessed by VAS scale over the 14 day treatment 
period.
Patient satisfaction during wear assessed over the 14 day 
period. This includes leakage, feeling of moisture on the skin, 
odour control, level of protection, comfort and showerproof 
qualities.
Ease of application and removal of the PICO 14 dressing.
Dressing wear time.
Dressing conformability.
Dressing change frequency and reason for dressing change.
Clinician acceptability of PICO 14 system at discontinuation 
of therapy.
Patient acceptability of PICO 14 system at discontinuation of 
therapy.
Chronic wounds and dehisced surgical wounds only:
Clinical performance and safety of the PICO 14 NPWT system over 
a 28 day therapy and no follow-up period to include:
Incidence of clinical infection. 
Appearance of the wound in terms of, tissue type and 
amount, exudate type and amount, skin condition 
surrounding the wound, peripheral tissue edema and 
induration. 
Condition of peri-wound skin assessed through visual 
inspection at 7, 14, 21 and 28 days.
Percentage reduction in area and volume from baseline to 
day 7, day 14, 21 and day 28. 
Level of pain on application, during wear and at dressing 
removal assessed by VAS scale over the 28 day treatment 
period.
Patient satisfaction during wear assessed over the 28 day 
period (for each treatment period). This includes overall 
performance of dressing, comfort, noise level, discreteness, 

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 10 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and 
is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
portability, interference with daily living –
showering, 
sleeping, socializing and working.
Ease of application and removal of the PICO 14 dressing.
Dressing wear time.
Dressing conformability
Dressing change frequency and reason for dressing change.
Clinician acceptability of PICO 14 system at discontinuation 
of therapy.
Patient acceptability of PICO 14 system at discontinuation of 
therapy.
Other endpoint(s):
No other end points.
Safety Data
Data will be collected on adverse events and device deficiencies 
during the study period.

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 11 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and 
is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
STUDY SCHEDULE- CLOSED INCISIONS ONLY.
Schedule of events 
Pre-
Operative
Data
Operative 
Data
DAY 0
DAY 7 Visit 
(-3 days)
End of 
therapy 
assessm
ent 
DAY 14 (-
2 days)
Exit visit
DAY 30 (±3 
days)
Additional 
dressing 
change
(Day 1-13)
Unsche
duled 
Visit or 
Early 
Exit
Informed Consent
X
Inclusion/Exclusion
X
X
Demographics/ Medical History
X
X
Incision assessment 
X
X
X
X
X
Dressing assessment 
X
X
X
X
Complications assessment
X
X
X
X
X
X
Photographic assessment
X
X
X
X
X
X
Operative Collection
X
X
POSAS
X
X
Concomitant Medication
X
X
X
X
X
X
X
Dressing application
x
x
Return to 
standard 
care
X
X
Dressing removal Assessment
X
X
X
X
Patient and clinician acceptability 
questionnaire completion 
X
X
X
X
Discharge Data Collection, if 
applicable
X
Adverse Event Assessment
X
X
X
X
X
X
X
Device Deficiency Assessment
X
X
X
X
X
End of Study/Exit  
X
X

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 12 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and 
is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
STUDY SCHEDULE- CHRONIC WOUNDS AND DEHISCED SURGICAL 
WOUNDS ONLY.
Schedule of events 
Pre-
Treatment
Data
Treatment 
Data
DAY 0
DAY 7 
Visit (-3 
days)
DAY 14 
Visit (-2 
days)
Day 21 
Visit (-3 
days)
End of therapy 
and Exit visit
DAY 28 (-3 
days)
Additional 
dressing 
change
(Day 1-27)
Unsched
uled Visit 
or Early 
Exit
Informed Consent
X
Inclusion/Exclusion 
X
X
Demographics/ 
Medical History
X
X
Wound Assessment 
(including 
measurement)
X
X
X
X
X
X
Dressing 
assessment 
X
X
X
X
X
Complications 
assessment
X
X
X
X
X
X
X
Photographic 
assessment
X
X
X
X
X
X
X
Treatment Data 
Collection
X
X
X
X
X
Concomitant 
medication
X
X
X
X
X
X
X
X
Dressing application
X
X
X
X
Return to 
standard care
X
X
Dressing removal 
Assessment 
X
X
X
X
X
X
Patient and clinician 
acceptability 
questionnaire 
completion 
X
X
X
X
X
X
Adverse Event 
Assessment
X
X
X
X
X
X
X
X
Device Deficiency 
Assessment
X
X
X
X
X
X
End of Study/Exit  
X
X

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 13 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and 
is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
STUDY CONTENTS.
TABLE OF CONTENTS.
Signatures. ..............................................................................................................................2
Principal Investigator Signature Page. ..............................................................................2
Coordinating Investigator Approval...................................................................................3
Sponsor Approval.............................................................................................................4
SYNOPSIS. .............................................................................................................................5
STUDY SCHEDULE- CLOSED INCISIONS ONLY.........................................................11
STUDY SCHEDULE- CHRONIC WOUNDS and Dehisced surgical wounds ONLY.........12
STUDY CONTENTS. .............................................................................................................13
Table of Contents...........................................................................................................13
List of Tables..................................................................................................................16
List of Figures. ...............................................................................................................16
List of Abbreviations And definitions. ..............................................................................17
Introduction............................................................................................................................19
Background....................................................................................................................19
Literature Summary........................................................................................................21
Study Purpose. ..............................................................................................................30
Safety Considerations. ...................................................................................................30
Benefits..........................................................................................................................35
Anticipated Serious Adverse Device Effects. ..................................................................35
OVERALL BENEFIT/RISK ANALYSIS............................................................................35
Objective(s)............................................................................................................................36
Primary Objective...........................................................................................................36
Secondary Objectives. ...................................................................................................36
Other Objectives. ...........................................................................................................37
Safety. ...........................................................................................................................37
Claims............................................................................................................................37
Investigational Products. ........................................................................................................37
Identification...................................................................................................................37
Comparator Treatment. ..................................................................................................40
Product Use...................................................................................................................41
Investigational product – PICO 14. .................................................................................41

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 14 of 131
CONFIDENTIAL AND PROPRIETARY
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is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
Labeling of Investigational Product. ................................................................................41
Product Accountability Procedures. ................................................................................41
Subject Enrollment and Withdrawal. .......................................................................................42
Subject Population. ........................................................................................................42
Inclusion Criteria. ...........................................................................................................42
EXLUSION CRITERIA ...................................................................................................44
Screening.......................................................................................................................45
Informed Consent...........................................................................................................45
Enrollment......................................................................................................................47
Lost to Follow-Up. ..........................................................................................................47
Withdrawal. ....................................................................................................................48
Study Design .........................................................................................................................49
Study Design..................................................................................................................49
Allocation and Blinding ...................................................................................................53
Data Management..........................................................................................................53
Data Review and Quality Assurance...............................................................................53
Retention Period ............................................................................................................54
Study Endpoints.............................................................................................................54
Methods Used to Minimize Bias and Maximize Validity. ..................................................56
Study Procedures - CLOSED incisions only............................................................................56
Visits and Examinations. ................................................................................................56
Study Methods and Measurements. ...............................................................................66
PICO 14 Device Return..................................................................................................73
HEALTH ECONOMICS/QUALITY OF LIFE. ...................................................................74
SCAR QUALITY ASSESSMENT (AT DAY 0, DAY 14 AND AT EXIT VISIT). ..................74
STUDY PROCEDURES- Chronic wounds and Dehisched surgical wounds ONLY. ................75
VISITS AND EXAMINATIONS........................................................................................75
DISCONTINUED SUBJECTS.........................................................................................84
Subject Pregnancy.........................................................................................................84
Study Methods and Measurements - chronic wounds and dehisced surgical wounds only.
85
PICO 14 Device Return..................................................................................................93
HEALTH Economics/Quality of Life. ...............................................................................93
Statistical Design. ..................................................................................................................93
General..........................................................................................................................94
Analysis Populations. .....................................................................................................94

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 15 of 131
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is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
Baseline Data.................................................................................................................95
Efficacy Analysis. ...........................................................................................................95
Analysis of Primary Endpoint..........................................................................................95
Analysis of Secondary Endpoints. ..................................................................................97
Analysis of Other Endpoint(s). ......................................................................................100
Safety Analyses. ..........................................................................................................100
Interim Analyses...........................................................................................................101
Sample Size Justification..............................................................................................101
Adverse Events and Device Deficiencies..............................................................................102
Definitions. ...................................................................................................................102
AE Coding Dictionary. ..................................................................................................106
Reporting Procedures. .................................................................................................106
EVALUATION AND REPORTING OF DD ............................................................................108
Figure 13-1: EVALUATION AND REPORTING OF DD....................................................................108
Unblinding of Investigational Product............................................................................108
Follow-up of Subjects with Adverse Events...................................................................108
INVESTIGATOR OBLIGATIONS..........................................................................................109
SPONSOR AND MONITOR RESPONSIBILITIES. ...............................................................109
Site Qualification Visit...................................................................................................110
Site Initiation Visit.........................................................................................................110
Interim Monitoring Visit.................................................................................................110
Sponsor Audits and Regulatory Inspection. ..................................................................110
Close-out Visit..............................................................................................................110
PROTOCOL AMENDMENTS...............................................................................................111
CONFIDENTIALITY OF THE STUDY...........................................................................111
STATEMENTS OF COMPLIANCE. ..............................................................................111
END OF STUDY. .........................................................................................................111
PUBLICATION POLICY .......................................................................................................112
Publication of Study Data .............................................................................................112
Data Sharing................................................................................................................112
REFERENCES ....................................................................................................................113
APPENDICES......................................................................................................................116
Protocol Amendment....................................................................................................116
Instructions For Use.............................................................................................................121
Principal Investigator Obligations (ISO14155:2011)..............................................................121
The Patient and Observer Scar Assessment Scale (POSAS). ..............................................129

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 16 of 131
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is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
LIST OF TABLES.
Table 9.1-1: Study Procedures by Visit - Closed Incisions ONLY.......................................................57
Table 10.1-1: Study Procedures by Visit- Chronic wounds and Dehisced surgical wounds ONLY.......75
Table 12.1-1: Categories of Adverse Event .....................................................................................102
LIST OF FIGURES.
Figure 12.3-12-1: Evaluation and Reporting of AE...........................................................................107
Figure 13-1: Evaluation and Reporting of DD ..................................................................................108

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 17 of 131
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is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
LIST OF ABBREVIATIONS AND DEFINITIONS.
Abbreviation
Definition
ADE
Adverse Device Effect(s)
AE
Adverse Event(s)
BSI
British Standards Institute
CE
Conformité Européene 
CER
Clinical Evaluation Report
CRF
Case Report Form(s)
CRO
Contract Research Organization
CV
Curriculum Vitae
DD
Device Deficiency(ies)
FAS
Full Analysis Set Population
FDA
Food and Drug Administration
FU
Follow-Up
GCP
Good Clinical Practice
HIPAA
Health Information Portability Accountability Act
ICH
International Conference on Harmonisation 
IEC
Independent Ethics Committee
IFU
Instructions for Use
ISF
Investigator Site File
ITT
Intention to Treat population
LOCF
Last Observation Carried Forward
MedDRA
Medical Dictionary for Regulatory Activities 
NA or N/A
Not Applicable
N (or n)
Total Sample Size (or subgroup sample size)
NHS
National Health Service 
PI
Principal Investigator
PMCF
Post-Market Clinical Follow

Study Protocol
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12SEP2021
Page: 18 of 131
CONFIDENTIAL AND PROPRIETARY
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is intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor 
shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make 
Abbreviation
Definition
PP
Per-protocol Population
RCT
Randomized Controlled Trial
S+N
T. J. Smith & Nephew Medical Ltd.
SADE
Serious Adverse Device Effect(s)
SAE
Serious Adverse Event(s)
SAF
Safety population
SAP
Statistical Analysis Plan
Tx
Treatment
VAS
Visual Analogue Score
USADE
Unanticipated Serious Adverse Device Effect(s)

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
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INTRODUCTION
BACKGROUND 
4.1.1
THE COST OF WOUND HEALING FAILURES AND COMPLICATIONS.
Facilitation of effective wound healing should be one of the primary therapeutic targets in any 
instance where injury to the skin tissue has occurred. Surgical procedures that result in disruption 
to the skin tissue include closed surgical incisions, posing its own challenges in the healing 
process. Skin grafting has been routinely adopted in defects that cannot be closed directly, 
encompassing a range of chronic1 and acute wounds2. Due to the nature of grafts they have 
shown to be complex to heal3, with major causes of failure being the formation of blisters or 
hematoma beneath the graft3 and infection development. Closed surgical incisions involve 
primary closure of wounds following surgical procedures4. These incisions may encounter surgical 
site complications; however the degree of risk is likely to differ. Complications may consist of 
wound dehiscence, cellulitis, necrosis, superficial, deep and organ space surgical site infection, 
and delayed healing5,6.
Due to their distinctive features the definition of success when treating each wound type can be 
reported differently within the literature, however ultimately the goal remains the same. For closed 
abdominal incisions and closed knee arthroplasty achievement of complete healing and 
avoidance of surgical site complications are common endpoints. Wound complications rates have 
been documented between 26-34%6-8 and 9-12%9-11 in closed abdominal incisions and closed 
knee arthroplasty respectively. A common factor that each wound type shares is the potential for 
failures to result in reoperation, re-hospitalisation, prolonged length of hospital stay and additional 
treatment resulting in increased costs6,12,13. In burns unit inpatients it has been shown that skin 
graft costs were $17,220 14, while wound complications following laparotomy are estimated to be 
an additional $2,000–$3,700 6,15. In primary total knee arthroplasty the mean direct costs of 30 
day readmissions has been shown as $13,008 and revision cases even higher at $29,893 16.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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In addition to the financial burden, failure to heal can negatively impact patient’s lives affecting 
physical, social, emotional and economic wellbeing 6,17. Therefore it is vital that the primary focus 
of wound management is to achieve full healing in a timely manner without impediment.
4.1.2
USE OF PORTABLE NEGATIVE PRESSURE IN WOUND HEALING.
Negative Pressure Wound Therapy (NPWT) was first developed in the 1990s’ - with dramatic 
uptake since its establishment. It has been shown to be effective in the management of acute and 
chronic open wounds18. In current literature use of NPWT has demonstrated a good success rates 
in skin grafts3, closed abdominal incisions19 and closed knee arthroplasty20. NPWT use on 
general surgery closed incisions has been reported to reduce surgical site complications including 
infection21,22, dehiscence23 and delayed healing24. This has also included some studies using 
single-use NPWT25-27. 
The PICO pump is a canister-free, disposable, single-use NPWT device which generates an 
effective nominal negative pressure of 80 mm Hg28 and provides therapy for up to fourteen days. 
The PICO pump is connected to a conformable dressing which is designed to be easily applied 
and removed, while minimising skin trauma29. The device delivers negative pressure across the 
wound bed or closed incision30 and surrounding area, and manages the fluid away from the wound 
or closed incision through a unique combination of absorbency and evaporation28,30.
It is thought that NPWT may have numerous mechanisms of action when used to manage skin 
grafts and surgical incisions. Successful integration of grafts to the recipient area consists of three 
phases: firstly a fibrin layer forms binding the graft to the bed, secondly recipient and donor end 
capillaries align and finally the graft is revascularised31. It is thought that NPWT could facilitate 
this process through increased local blood flow, closer proximity of graft to wound bed, removing 
seromas and hematomas from under the graft, reducing bacterial load and preventing shearing 
of the graft32. Sposato et al (2001)33  supported this understanding reporting that NPWT draws 
secretions through a vacuum-sealed dressing, preventing accumulation of fluid underneath the 
graft. In surgical incisions the main mechanisms of action involve reducing oedema, stimulating 
perfusion, and managing exudate. Post-operative oedema in the peri-wound tissue is thought to 
limit tissue perfusion and high levels of wound fluid loss have been correlated with increased risk 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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of post-operative infection and dehiscence34. Xia et al (2014)35 demonstrated that in 20 patients 
with infected wounds NPWT significantly increased blood flow in the wounds when compared to 
pre application levels. In a study by Young et al (2012)36 four patients with pressure ulcers had 
oedema and wound bed thickness assessed during follow-up. They demonstrated a rapid 
reduction of periwound tissue oedema over four days and a 20% increase in thickness of wound 
bed by day seven of therapy.
Ultimately use of NPWT for skin grafts, closed surgical incisions will be judged on its ability to 
increase healing success rates while minimising risk of complications. To enable it to achieve this 
it must be amenable with patients and healthcare practitioner’s requirements and so ensure 
compliance with the required negative pressure protocol.
A summary of known and potential risks and benefits to humans of the Investigational Product 
(IP) can be found in the Package Insert/Instructions for Use of PICO 14. 
LITERATURE SUMMARY.
For each of the wound types a literature search was conducted to identify studies involving NPWT 
with particular focus on single-use portable systems where possible. Key studies relating to each 
area have been described below.
Application as a post-operative dressing for surgically closed incisions is a relatively new use of 
NPWT; however despite this it has still received reasonable attention within the literature. 
In 2019, NICE (UK) released a guidance document recommending the use of PICO38 on closed 
surgical incisions (in high-risk patients), following an assessment of the clinical evidence for the 
device against standard of care. It is also worth noting that a Medtech Innovation Briefing released 
by NICE (UK) also exists for PREVENA37, however, this document does not make any 
recommendations on the value or benefits of using PREVENA on closed surgical incisions. 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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In the case of PICO 37, a meta-analysis was performed on 31 studies, 15 of which were RCTs and 
16 non-randomised comparative observational studies. The study design for the RCTs was based 
on the prevention of SSCs in closed surgical incisions at high risk of complications post-operation 
in 5 different surgical specialties: orthopaedic, colorectal, obstetric, plastic and cardiothoracic. 
Pooled effect estimates from a random-effects meta-analysis of the 8 studies showed a significant 
reduction in surgical site infection rates in favour of PICO dressings (n=1,804, odds ratio [OR] 
0.51, 95% confidence interval [CI] 0.3 to 0.82; p=0.006).  Of the 16 non-randomised comparative 
observational studies, 10 compared the rates of SSI using PICO dressings with standard wound 
dressings in people with closed surgical incisions. The studies included 6 different types of surgery 
(orthopaedic, colorectal, obstetric, plastic, cardiothoracic and vascular). Pooled effect estimates 
from a random-effects meta-analysis of the 10 studies showed a significant reduction in SSI in 
favour of PICO dressings (n=2,669, OR 0.27, 95% CI 0.14 to 0.53; p=0.001). However, these 
observational studies may have overestimate the clinical benefits of PICO dressings because of 
potential selection and publication bias. 
From these 31 studies, NICE found that reductions in SSI with PICO varied across different types 
of surgery: it was only significantly reduced by PICO in obstetric surgery and orthopaedic surgery. 
However, the rate of seroma was reduced in 2 RCTs and 5 observational studies in a range of 
surgical specialties (n=771, OR 0.19, 95% CI 0.08 to 0.47; p=0.0003). In terms of adverse effects, 
NICE pointed out that PICO may be linked to increased risk of skin blisters. One RCT reported a 
higher overall rate of blisters in people who had PICO compared with those who had standard 
wound dressings (11% versus 1%). The rates of blisters varied considerably between the 3 
surgeons who conducted the study. 
The main conclusions of the NICE guidance were: 1) it supports the use of PICO NPWT for closed 
surgical incisions in the NHS (UK) based on the association of fewer surgical site infections and 
seromas with these devices compared with standard wound dressings; 2) PICO should be 
considered as an option for closed surgical incisions in people who are at high risk of developing 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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surgical site infections; 3)  PICO was judged to provide extra clinical benefits at a similar overall 
cost compared with standard wound dressings.
A recent randomised controlled trial38 compared the postoperative surgical site infection in closed 
laparotomy wounds treated with either PICO or standard dressings. In the 50 patients (25 per 
cohort) it was shown that incidence of surgical site infection at 30 days postoperatively was 
significantly reduced within the group treated with PICO (8.3% NPWT; 32.0% control, p = 0.043). 
This advantage of treatment with PICO was also reflected in a significant reduction in the length 
of hospital stay (6.1 days NPWT; 14.7 days control, p = 0.019). In Pellino et al‘s 27 prospective 
study (2014), also using PICO, they assessed similar outcomes of surgical site events and 
compared results to a cohort using conventional dressings. Patients enrolled in the study included 
those undergoing primary wound closure following breast or colorectal surgery. In the equally 
divided 50 patient colorectal surgery cohort, PICO resulted in significantly fewer instances of 
surgical site events (2 NPWT; 11 control, p = 0.008). It also resulted in nearly half the length of 
hospital stay compared to patients treated with conventional dressings (7.1 days NPWT; 12 days 
control, p = 0.001). These findings have been further confirmed through a meta-analysis subgroup 
comparing PICO to standard care in abdominal surgery26.
In revision hip and knee surgery Cooper and Bas (2016)39 have previously compared the outcomes 
of closed incision NPWT and sterile antimicrobial dressing. In this 138 patient (30 NPWT; 108 
antimicrobial dressing) retrospective study they found the NPWT cohort developed significantly 
fewer overall wound complications (6.7% NPWT; 26.9% antimicrobial dressing, p = 0.024). Total 
surgical site infections were also shown to be lessened (3.3% NPWT; 18.5% antimicrobial dressing, 
p = 0.045). Furthermore, trends highlighted a lower number of superficial wound dehiscence and 
reoperations in the NPWT group; however these findings were non-significant. Karlakki et al 
(2016)20 came to a similar conclusion when they evaluated the use of PICO in patients undergoing 
elective primary total hip and knee arthroplasties. Within this non-blinded randomised control trial 
220 patients were recruited and assigned to be treated with either incisional NPWT or conventional 
dressings. Their findings revealed that NPWT resulted in a non-significant lower number of surgical 
wound complications when compared to the conventional dressing group (2.0% NPWT; 8.4% 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
control, p = 0.06) and a shorter hospital stay (3.8 days NPWT; 4.7 days control, p = 0.07). Further 
studies have suggested the same trend in reduced wound complication when PICO is applied to 
hip and knee revision arthroplasties40, however this is not unanimously agreed upon for all NPWT 
systems41.
Finally, in their study Hudson et al (2015)34 brought all these wound types together in a prospective, 
open label, non-comparative study. They assessed the functionality and performance of PICO in 
20 patients with closed surgical wounds (including knee implants and abdominal), traumatic 
wounds or meshed split thickness skin grafts. Results showed within 14 days 55% of wounds had 
closed with a further 40% progressing to closure. In three case examples this study also 
demonstrated the ability for, the then prototype, PICO system to achieve near continuous negative 
pressure within therapy limits. Provided as a convenient, all-in-one, canister-free system, the 
current PICO versions support patients in maintaining their daily activities. Patients may be safely 
discharged with PICO in place28,29,42. The size and simplicity gives patients’ confidence that they 
can manage the system at home. 
Surgical wounds at risk or surgical wounds with surgical site complications 
(SSC).
This study will focus on closed surgical wounds in patients at risk of a surgical site complication 
(SSC) that may cause the healing process to stall (become sub-acute), or lead to poor tissue 
repair, excessive scarring and/or other adverse outcomes. The  main risk factors associated with 
developing SSCs37 are shown below in Table 4.2-1.
Patient-related
Surgery-related 
Age >65 years 
Diabetes
Obesity
Cigarette smoking
Underlying illness e.g. COPD, renal insufficiency
Nutritional status
Radiation or chemotherapy exposure
Wound classification 
Site and complexity of the procedure 
Repeat operations 
Emergency operations

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A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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Risk factors for surgical site infection
Table 4.2-1 Describing characteristics in a patient with risk factors that can lead to higher risk of SSI.
The most common wound-site complications are dehiscence, haematoma, seroma and surgical 
site infections (SSIs) (Figure 4.2-1, below). These are often interconnected, potentially serious 
complications can result in delayed or poor quality healing. Dehiscence, when a wound bursts 
open, can have multiple causes such as overtight closure of the wound edges, over use of the 
wound area leading to failure of the closure method and infection. Haematoma is a complication 
involving a collection of blood and fluid beneath the suture line/wound closure, which may force 
the wound to open up/dehisce. Seromas, common after breast mastectomy and some other types 
of surgery, are pockets of clear serous fluid that may persist until resorbed by the body. 
Sometimes, calcified tissue forms. 
Figure 4.2-1: Relationships between surgical site complications
In respect of SSIs, the important clinical features are peri-incisional erythema, serous or purulent 
exudate and superficial dehiscence, which may be accompanied by systemic signs43. They can 
Compromised immunity, such as high dose steroid 
therapy

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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be classified as superficial incisional, deep incisional or organ/space infections and are applicable 
to all types of surgery44. For a small number of patients, SSI may progress beyond a superficial 
wound infection to a deep incisional or organ/space infection and affect grafts and prostheses. 
PICO use in chronic wounds.
Chronic wounds are defined as wounds which are characterised by either delayed healing 
(typically more than 6-12 weeks) or by wounds which do not heal at all. In the US alone, an 
estimated 4.5 million people have chronic wounds108. Wounds can become chronic for a number 
of reasons; often they are stalled in the inflammatory stage of the healing process and the 
presence of elevated levels of matrix metallo-proteases (MMPs) as an underlying cause of wound 
chronicity has recently been identified. 
Although commonly grouped together, chronic wounds are more correctly defined and treated 
according to their underlying aetiology.
Negative Pressure Wound Therapy (NPWT) in its modern form first appeared in mainstream 
clinical medicine with the publication of two back to back articles in Annals of Plastic Surgery in 
1997 12,13. The first article examined the mechanisms of action of NPWT using pigs and the second 
article described the clinical effects of NPWT on a wide range of acute, sub-acute and chronic 
wounds. Simply stated, NPWT consists of inserting a filler such as a polyurethane foam into a 
wound; covering the wound and filler with a film dressing and applying suction (negative pressure) 
to the enclosed cavity. In essence, the clinician had converted an open wound into a closed wound 
and the application of suction removes wound exudates which are conventionally collected in a 
canister connected in series with the suction. 
NPWT is often referred to as vacuum assisted closure or “VAC” (although this is actually a brand 
name owned by a manufacturer, Kinetic Concepts Inc. KCI); topical negative pressure (TPN); or 
sub atmospheric pressure. In this review NPWT will be used throughout as this term has being 
adopted by clinicians and all manufacturers as a generic term for this type of treatment. 
NPWT has quickly been established as a fundamental clinical tool for treating a wide range of 
wounds that pose the most difficult challenges in both adults and paediatric patients. For example, 
Argenta & Morykwas13 reported their experiences in 300 wounds of which 296 responded 
favourably. The wounds consisted of 175 chronic wounds, which by definition have proved to be 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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slow to heal; 94 sub-acute wounds such surgical incisions that have dehisced and now represent 
a significant and unexpected burden on the clinician and patient; and 31 acute wounds such as 
traumatic injuries which also responded well to NPWT. Such wounds could be dressed with 
relatively simple absorbent or occlusive dressings, whereas NPWT typically requires the 
additional expense and inconvenience of suction (often a heavy electrical pump) and a canister 
to collect the wound exudate. Clearly the difficulties presented by the application of NPWT provide 
significant beneficial effects so as to offset its disadvantages. Antony & Terrazas 200414 
described early experiences of NPWT treated patients where persistent wound infections in 42 
sternal, spinal and lower extremity wounds were treated with antimicrobials and NPWT for a mean 
duration of 29.3 days with all wounds eventually closing by around 8 weeks. This illustrates a 
fundamental principle of NPWT. NPWT is very often used to regain control of the wound; to kick 
start the healing process and progress the wound along a healing trajectory so that conventional 
wound therapy can be resumed with greater effect. Until recently, NPWT was seldom used all the 
way through second intention closure.
Wada et al 200615 treated difficult to heal complex lower extremity wounds, sacral pressure 
ulcers and traumatic wounds with NPWT for a period of only 8 days after which surgical 
procedures (skin grafts or flaps) were used to close the wounds successfully. The preparation of 
the wound bed and the use of NPWT to improve the efficacy of subsequent surgical procedures 
is another clear characteristic of the way NPWT is deployed. The use of NPWT on specific clinical 
indications will be covered in greater detail below. NPWT has also been successfully applied to a 
wide range of wounds in paediatric and neonatal patients16-18.
Chronic wounds in Literature are well supported with a total of 318 patients reported. Five 
comparative studies (Dowsett et al, 201745, Schwartz et al, 201546, Kirsner et al, 201947, 
CIME/02148  and Wang et al, 201749) found significant decreases in wound size when compared 
to comparators. Most other studies saw healing or reductions in wound size.
The total number of patients with ulcers treated with the PICO system in published, peer-reviewed 
studies was 261 Adeyami & Waycaster, 2018 16. Commonly reported outcomes related to wound 
healing or wound size reduction. Patient/clinician satisfaction was also measured in several 

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management of acute and chronic wounds
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studies45,46,50, with most feedback being positive. Many studies were not comparative, or did not 
carry out statistics and so only Dowsett et al, 2017, Schwartz et al, 2015, Kirsner et al, 2019 and 
Wang et al, 201749 found significant decrease in wound size. No studies reported significantly 
worse outcomes for the use of PICO on this indication.
With regards to adverse events, complications and complaints observed in the literature, no device 
related adverse events or complications were reported in most studies45,49,51-56. Hurd et al, 201450
reported that 7% of patients discontinued treatment due to hospitalization , 8% due to excessive 
exudate, and 3% on doctor’s orders (unknown reason). There was one death (0.3%), and 1.5% 
discontinued for unknown reasons. It was also reported that device related reasons for treatment 
discontinuation were loss of seal in 3.1%, and poor patient compliance in 1.9%. Schwartz et al, 
201546 reported wound infection in 16.6% of patients, and local irritation due to fixation strips in 
8.3%. Kirsner et al, 201947 reported AEs in 3.8% that were likely to be device related, this was 
lower than the comparator which reported an 11% AE rate. No adverse events were observed in 
Menzies et al, 201757 although 1 patient (25%) was unable to obtain a seal due to use of PICO on 
the neck.
It is clear that the patient populations intended to be exposed to PICO are very wide. These 
various populations are comprised of relatively healthy individuals with acute traumatic wounds 
through to patients with acute surgical wounds and/or patients with concomitant medical 
disorders, such as peripheral vascular disease and/or diabetes, particularly within the context of 
chronic wounds. Whilst a large segment of the patient population, especially in regard to chronic 
wounds, may be elderly, the proposed intended uses of PICO NPWT systems do not preclude 
patients of any particular age or demographic. Indeed, within the context of trauma, burn wounds 
and/or surgical wounds, it is realistic to anticipate that the clinical use of PICO NPWT systems 
will extend from childhood and adolescence, into adulthood and the elderly.
Overall, based on its intended clinical use PICO 14 is considered to be clinically interchangeable 
for the management of chronic wounds, acute wounds, traumatic wounds, sub-acute and 
dehisced wounds, ulcers (such as pressure or diabetic), partial thickness burns, flaps and grafts, 
and surgically closed incision wounds. 

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management of acute and chronic wounds
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Where a wound is proving difficult to heal, the typical approach is now often to try standard care 
(compression therapy, advanced wound dressings) first before progressing to more advanced 
techniques should this prove unsuccessful. Some of these advanced therapies are discussed 
below: 
Despite analyzing 78 RCTs (7014 participants primarily women) in a Cochrane review and network 
systematic analysis of dressings, including silver, impregnated, and topical agents for treating 
VLUs, there was no certainty regarding which were most effective for healing86. In general, the 
studies had small numbers of patients per treatment and there was a high risk of bias. 
Moues et al 2011129, in a systematic review of NPWT which identified more than 400 clinical 
papers and review articles, identified a single RCT in regard to the use of NPWT in VLUs and 
reported faster wound bed preparation times, faster median time to complete healing and better 
skin graft take rate in NPWT treated wounds. The authors noted the cost efficiency in favour of 
NPWT in this indication. 
Dumville et al 2015a130 performed a systematic review in regard to the use of NPWT used within 
the context of leg ulcers in any care setting. For this review, the authors searched several 
healthcare databases for published and unpublished RCTs comparing the effects of NPWT with 
alternative treatments or different types of NPWT in the treatment of leg ulcers; only one 60 patient 
randomised study was identified. In this study population, the authors report a range of ulcer types 
that were venous arteriolosclerotic and venous/arterial in origin. Study participants had 
recalcitrant ulcers that had not healed after treatment over a six-month period. Participants 
allocated to NPWT received continuous negative pressure until they achieved 100% granulation 
(wound preparation stage). A punch skin-graft transplantation was conducted and the wound then 
exposed to further NPWT for four days followed by standard care. Participants allocated to the 
control arm received standard care with dressings and compression until 100% granulation was 
achieved. These participants also received a punch skin-graft transplant and then further 
treatment with standard care. All participants were treated as in-patients until healing occurred. 
The authors reported that there was low quality evidence of a difference in time to healing that 
favoured the NPWT group: the study reported an adjusted hazard ratio of 3.2, with 95% 
confidence intervals (CI) 1.7 to 6.2. The follow-up period of the study was a minimum of 12 
months. There was no evidence of a difference in the total number of ulcers healed (29/30 in each 

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CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
group) over the follow-up period; this finding was also low quality evidence. There was low quality 
evidence of a difference in time to wound preparation for surgery that favoured NPWT (hazard 
ratio 2.4, 95% CI 1.2 to 4.7). Limited data on adverse events were collected: these provided low 
quality evidence of no difference in pain scores and Euroqol (EQ-5D) scores at eight weeks after 
surgery.
STUDY PURPOSE.
Most previous studies have used traditional NPWT systems as part of their design. Though the 
technical applications of the traditional and newer single-use systems are comparable it is possible 
that some of the features of the latter may influence clinical outcomes. In addition to the limitations 
highlighted above, the cited studies have seldom assessed the ease of management and 
acceptability of NPWT systems. Although clinical outcomes may be considered paramount, these 
usability factors could also play a key role in ensuring compliance with negative pressure 
protocols.
This study is being conducted to evaluate the safe and effective use of the PICO 14 system in 
chronic wounds and surgically closed incision sites as part of the Post Market Clinical Follow Up
plan for this product, for the purpose of continuing CE (Conformité Européene) Mark approval in 
accordance with MEDDEV 2.12-2. 
The aim of this study is to assess the safety and performance of the PICO 14 system in
surgically closed incisions, chronic wounds and dehisced surgical wounds. 
A summary of known and potential risks and benefits to humans of each test article can be found 
in the Instructions for Use of PICO 14.
SAFETY CONSIDERATIONS.
The Healthcare Professional (HCP) should read the IFU for PICO 14 before use. The IFU gives 
full details on the contraindications and precautions to take with use of the product and include:
Contraindications:

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 31 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
PICO 14 is contraindicated for:
•
Patients with malignancy in the wound bed or margins of the wound (except in palliative 
care to enhance quality of life).
•
Previously confirmed and untreated osteomyelitis.
•
Non-enteric and unexplored fistulas.
•
Necrotic tissue with eschar present.
•
Exposed arteries, veins, nerves or organs.
•
Exposed anastomotic sites.
PICO 14 should not be used for the purpose of:
•
Emergency airway aspiration.
•
Pleural, mediastinal or chest tube drainage.
•
Surgical suction.
Warnings:
•
The PICO 14 pump contains a magnet. Interaction between your device and other medical 
devices can result in device failure and lead to serious harm, including death. For this 
reason the device must be kept at least 10cm away from all implantable or life sustaining 
medical devices. Extension tubes are included to enable the pump to be positioned more 
than 10cm away from any devices that could be affected. This warning applies to ALL 
users including patients, caregivers, healthcare professionals and all persons close to the 
device.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 32 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
•
Certain patients are at high risk of bleeding complications which, if uncontrolled, could 
potentially be fatal. Patients must be closely monitored for bleeding. If sudden or increased 
bleeding is observed, immediately disconnect pump, leave dressing in place, take 
appropriate measures to stop bleeding and seek immediate medical assistance.
•   
Haemostasis must be achieved before applying the dressing, although the use of 
anticoagulants does not deem a patient inappropriate for treatment with PICO 14. Patients 
suffering from difficult haemostasis or who are receiving anticoagulant therapy have an 
increased risk of bleeding. During therapy, avoid using haemostatic products that may 
increase the risk of bleeding, if disrupted. Frequent assessment must be maintained 
throughout the therapy.
•  
At all times care should be taken to ensure that the pump and tubing and connectors do 
not lie in a position where it could cause pressure damage to the patient.
•
Become twisted or trapped under clothing or bandages so that the NPWT is blocked.
•
The PICO 14 pump is not MRI compatible. Remove the PICO 14 pump from the dressing     
before entering the MRI suite.
•
PICO dressings should only be applied and changed by a healthcare professional. 
Precautions:
Precautions should be taken in the following types of patients who are at high risk of bleeding 
complications:
•
Receiving anticoagulant therapy or platelet aggregation inhibitors or actively bleeding.
•
Having weakened or friable blood vessels or organs in or around the wound as a result of, 
but not limited to; anastomoses, infection, trauma or radiation.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 33 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
•
Suffering from difficult wound haemostasis.
•
Untreated for malnutrition.
•
Non-compliant or combative.
•
Suffering from wounds in close proximity to blood vessels or delicate fascia.
•
PICO 14 does not contain audible alerts. The pump should be carried so that it is 
accessible and the patient/ healthcare professional can check the status routinely.
•
Although PICO dressings can be used under clothing/bedding, it is important that occlusive 
materials e.g. film dressings, are not applied over the pad area of the dressing as this will 
impair the intended evaporation of moisture through its outer layer.
•
Where PICO dressings are used on patients with fragile skin, a skin protectant such as 
SECURA™ No-Sting Barrier Film should be used on areas of skin where fixation strips are 
to be applied. Inappropriate use or repeated application of fixation strips may otherwise 
result in skin stripping.
•
Do not use PICO dressings with oil based products such as petrolatum as it may 
compromise establishing an effective seal.
•
PICO 14 may be used in conjunction with surgical drains provided the dressings not placed 
over tubing where it exits the skin. Any surgical drain should be routed under the skin away 
from the edge of the dressing and function independently of the PICO 14 System.
•
The pump must be protected from sources of fluid e.g. from incontinence or spillages. 
Discontinue PICO 14 use if fluid ingress is observed.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 34 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
•
When showering, the PICO 14 pump should be disconnected from the dressing. Whilst 
disconnected, ensure the end of the tubing attached to the dressing is facing down so that 
water does not enter the tube.
•
Do not cut the PICO dressing pad as this may lead to loss of NPWT application.
•
Always ensure that the PICO dressing is positioned centrally over the wound. The soft port 
should be positioned uppermost on intact skin and not extend over the wound so that the 
risk of fluid collecting around the soft port and potentially blocking the NPWT is minimised.
•
CT scans and x-ray have the potential to interfere with some electronic medical devices. 
Where possible, move the pump out of the x-ray or scanner range. If the pump has been 
taken into the CT scan or x-ray range, check that the system is functioning correctly 
following the procedure.
•
When applying dressings next to one another, ensure the dressing borders do not overlap.
The clinician should read the IFU for PICO 14 before use. The IFU gives further details of the 
above points and additional information on PICO 14 contraindications and precautions.
Risks associated with use of PICO 14 within the present study will be mitigated as follows:
•
Study personnel will be competent in the correct use of PICO 14 prior to applying the 
dressing to the wounds of study subjects. 
•
Study personnel will be trained on the study protocol.
•
Study personnel will be directed to carefully follow the inclusion and exclusion criteria for 
participation in the study when assessing patient eligibility.
•
Study personnel will be directed to read and follow the IFU. 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 35 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
•
PICO 14 will be used within its registered indication.
•
PICO 14 will only applied by a healthcare professional in line with the IFU.
BENEFITS.
PICO systems maintain a nominal (-80 mmHg) negative pressure wound therapy which may 
promote surgical site healing via removal of low to moderate levels of exudate and infectious 
materials. 
Potential benefits of this device include reduction of oedema, promotion of epithelialization at the
surgically closed incision site, and a reduction of SSI and other SSC. And in the case of chronic 
wounds and dehisced surgical wounds lack of signs of infection as well as wound area reduction. 
ANTICIPATED SERIOUS ADVERSE DEVICE EFFECTS.
Excessive bleeding is a serious risk associated with the application of suction to wounds which 
may result in death or serious injury. Careful patient selection, in view of the above stated 
contraindications, warnings and precautions is essential. Subjects with incisions that are actively 
bleeding are not eligible to participate in this study unless haemostasis has been achieved (to be 
confirmed during surgery). The surgical site and dressing should be monitored for any evidence 
of a change in the blood loss status of the subject.
OVERALL BENEFIT/RISK ANALYSIS.
The anticipated medical benefits are considered to outweigh the overall or individual residual risks 
associated with PICO 14 within the proposed indications. The risks associated with PICO 14 are 
addressed with reference to the warnings and precautions in the IFU.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 36 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
OBJECTIVE(S).
PRIMARY OBJECTIVE.
To assess the functional clinical performance of PICO 14 NPWT system over 14 days therapy 
through the verification of delivery of negative pressure and wound exudate management.
SECONDARY OBJECTIVES.
Closed incisions ONLY
To assess clinical efficacy and safety of the PICO 14 NPWT system within 30 days of surgery 
through:
Incidence of Surgical Site Infection (SSI) – Superficial, deep. [CDC criteria].
Incidence of Surgical site Complications (SSC) [as applicable: dehiscence 
(superficial/deep etc.), seroma, necrosis, hematoma, suture abscess].
Condition of peri-wound skin assessed through visual inspection at 7, 14 and 30 days.
Any pain experienced by the subject in relation to the PICO 14 system.
Patient tolerability assessed by level of pain and level of satisfaction.
Clinician acceptability assessed by ease of application and removal.
Dressing wear time, dressing change frequency and dressing conformability.
Scar quality measured by Patient and Observer Scar Assessment Scale (POSAS) score.
Chronic Wounds and dehisced surgical wounds ONLY
To assess clinical efficacy and safety of the PICO 14 NPWT system within 28 days therapy period 
through:
Incidence of infection.
Condition of peri-wound skin assessed through visual inspection at 7, 14, 21 and 28 days.
Any pain experienced by the subject in relation to the PICO 14 system.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 37 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Wound assessment:
o
Appearance of the wound.
o
Level of exudate.
o
Wound pain.
o
Size of wound (percentage reduction in area, depth, and volume).
Patient tolerability assessed by level of pain and level of satisfaction.
Clinician acceptability assessed by ease of application and removal.
Dressing wear time, dressing change frequency and dressing conformability.
OTHER OBJECTIVES.
No other objectives.
SAFETY.
To assess Adverse Events and Device Deficiencies.
CLAIMS.
Data generated from the study will populate a clinical study report which will feed into the clinical 
evaluation report for PICO 14 to evaluate the safe and effective use of the PICO 14 system in 
chronic open wounds and closed surgical incisions, and support part of the PMCF plan for this 
product, for the purpose of continuing CE (Conformité Européene) Mark approval in accordance 
with MEDDEV 2.12-2.
INVESTIGATIONAL PRODUCTS.
IDENTIFICATION.
6.1.1
INVESTIGATIONAL PRODUCT.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 38 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
PICO 14 is a single-use Negative Pressure Wound Therapy System consisting of a small portable 
pump, 2 AA batteries, 2 dressings and fixation strips. The PICO 14 pump maintains NPWT at 80 
mmHg (nominal) to the wound surface. Exudate is managed by the dressing through a 
combination of absorption and evaporation of moisture through the outer film. The PICO 14 dual 
dressing kit is intended to be used for up to 14 days on low to moderately exuding wounds. The 
frequency of dressing changes can be affected by multiple factors such as wound type, wound 
size, rate or volume of exudate, orientation or environmental conditions. Additional dressings will 
be provided as required.
PICO 14 may be used in a hospital or community setting and is indicated for acute and chronic, 
sub-acute, dehisced and traumatic wounds, flaps and grafts, surgically closed incision sites, and 
partial thickness burns. For this study, PICO 14 will be used to manage post-surgical wounds 
closed by primary intention, chronic wounds and dehisced surgical wounds as defined in the 
study eligibility criteria. PICO 14 is also used on chronic wounds such as Venous Leg ulcer, 
Arterial Leg Ulcer and Diabetic foot Ulcer and pressure ulcers. This is due to the PICO 14 pump 
capability of providing therapy for 14 days. PICO 14 will be applied for 14 days (for closed 
incisions only) with a dressing change at 7 days on low exuding wounds. For moderately/high 
exuding wounds each PICO dressing can be used for up to 4 days. 
Please note for chronic and dehisced surgical wounds PICO 14 may be applied for up to 
28 days by using two PICO 14 systems for treatment.
PICO 14 is manufactured by Smith+Nephew Medical Limited, 101 Hessle Road, Hull, HU3 2BN, 
UK. PICO 14 is packed in the UK with individual components made in the following countries:
o
Dressing – UK.
o
Fixation strips – origin as marked.
o
Pump – China.
o
Batteries – origin as marked.
The dressing is the part of the system that is applied directly to the patient. It is a 4 layer fluid 
management system that includes:

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 39 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
A top film layer with a high moisture vapour transmission rate allows one-way transpiration 
of exudate vapour.
Proprietary absorbent layer moves exudate away from the wound and initiates 
evaporation.
Airlock layer maintains open airflow and allows even distribution of negative pressure 
across the dressing.
Silicone contact allows fluid to pass and minimizes pain of removal.
The dressing sizes available for this product are: 
10 x 20 cm
10 x 30 cm
10 x 40 cm
15 x 15 cm
15 x 20 cm
15 x 30 cm
20 x 20 cm
25 x 25 cm
Small Multisite
Large Multisite
The adhesive fixation strips are polyurethane film and are used for secondary fixation around the 
edges of the dressing. This ensures a sufficient seal for the negative pressure to be maintained 
at the wound site. 
During this study, a subject will receive NPWT via the use of one (1) PICO 14 pump for 14 days 
with additional dressing changes taking place as clinically warranted throughout these 14 days.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 40 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
6.1.2
ANCILLARY PRODUCT.
SECURA No-Sting Barrier Film wipes
SECURA No-Sting Barrier Film wipes are water-based acrylate polymer-impregnated wipes, 
which can be used to protect the peri-wound skin prior to the application of the secondary fixation 
strips in subjects with more fragile skin. A supply of SECURA non-sting skin barrier wipes will be 
provided by S&N.
Catalogue #
Description
Units per Carton
66800712
SECURA No-Sting Barrier Film Wipe (1ml)
50 wipes
Manufacturer: Smith and Nephew Medical Limited, 101 Hessle Road, Hull, HU3 2BN, UK
RENASYS Adhesive Gel Patches
RENASYS Adhesive Gel Patches are double sided silicon adhesive hydrogel patches, which can 
be used to aid application in awkward areas, if required. A supply of RENASYS Adhesive Gel 
Patches will be provided by S&N.
Catalogue #
Description
Units per Carton
66801082
RENASYS Adhesive Gel Patches 
(10 x 7 cm)
10 strips 
Manufacturer: Smith and Nephew Medical Limited, 101 Hessle Road, Hull, HU3 2BN, UK.
COMPARATOR TREATMENT.
No comparator products will be used in this study.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 41 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
PRODUCT USE.
Sites will be requested to refer to the IFU for full guidance on how the dressings and fixation strips 
should be applied for PICO 14. The use of the PICO adhesive strips is mandatory for the IP per 
the application instructions in the IFU. All sites will be trained in and experienced in the use of 
PICO kits. This will be established through prior general use of PICO kits during routine medical 
practice at the site and through some practise use of PICO 14 if required, to minimise learning 
effects prior to the live phase of the study.
INVESTIGATIONAL PRODUCT – PICO 14.
Please refer to the IFU for full guidance on how the dressings and fixation strips should be applied. 
All sites will be trained and experienced in the use of PICO 14 kits. This will be established through 
prior general use of PICO 14 kits during routine medical practice at the site. Previous experience 
with PICO should include use on incision sites and not limited to open or chronic wounds.
LABELING OF INVESTIGATIONAL PRODUCT.
As all product supplied is commercially available and used within its approved indications there 
is no need for labelling.
PRODUCT ACCOUNTABILITY PROCEDURES.
The investigational site will maintain an inventory of the IP/Ancillary Products and Study Supplies. 
The Sponsor or its designee will provide a log(s) to facilitate IP/Ancillary Products and Study 
Supplies inventory control. All IP/Ancillary Products and Study Supplies accountability logs must 
be retained in the Investigator Site File (ISF). These records must be available for inspection by 
the Sponsor, its designees, or by regulatory agencies at any time.
The Study Monitor will ensure that the procedures and records are in place for the appropriate
reconciliation of all IP/Ancillary Products and Study Supplies. As part of monitoring, the Study 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 42 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Monitor will check that site personnel are following the proper procedures for accountability and 
completing all necessary documentation.
SUBJECT ENROLLMENT AND WITHDRAWAL.
SUBJECT POPULATION.
Seventy patients with Chronic open wounds (pressure ulcers, venous leg ulcers, diabetes-related 
foot ulcers, dehisced surgical wounds) and Closed surgical incisions, will be recruited to the study 
and will receive therapy with PICO 14. There will be a minimum of 10 of each of the following 
wound type; venous leg ulcers, diabetes-related foot ulcers, pressure ulcers, dehisced surgical 
wounds and post-operative incisions.The patients will be recruited from up to 7 sites in the United 
Kingdom, EU, and US, Canada. Sites failing to enroll may be replaced.
INCLUSION CRITERIA.
Subjects will be considered qualified for enrollment if they meet the following criteria:
1.
The subject must provide written informed consent.
2.
Subjects eighteen (18) years of age or older.
3.
Willing and able to make all required study visits.
4.
Able to follow instructions.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 43 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
5.
Closed Incision wounds ONLY:
Subject has a closed surgical incision which the clinician considers is suitable for 
PICO therapy, where it is expected that the therapy will be applied for a minimum of 
14 days.
Subject has a closed surgical incision which the clinician is deemed high risk of 
developing SSI.
Risk factors for surgical site infection
Patient-related
Surgery-related 
Age (> 65 years)
Diabetes
Obesity
Cigarette smoking
Underlying illness e.g. COPD, renal insufficiency
Nutritional status
Radiation or chemotherapy exposure
Compromised immunity, such as high dose steroid therapy
Wound classification 
Site and complexity of the 
procedure 
Repeat operations 
Emergency operations
Chronic wounds ONLY: 
Patients with any chronic wound* which the treating clinician deems is suitable for 
management with single-use disposable NPWT where it is expected that the therapy 
will applied for a minimum of 28 days.
*Chronic wound in this study is defined as any wound of less than three months duration 
that is not healing after 4 weeks of standard care and having addressed the 
underlying cause.
Dehisced surgical wounds ONLY:
Patients with dehisced wounds in which the clinician believes is suitable for PICO 
therapy where therapy is expected to be applied for up to 28 days.
*Wound dehiscence is a surgical complication in which two sides of a surgical incision 
separate and rupture along the incision, dehiscence typically is diagnosed after 2-3 
days post- surgery and up to a month with more complicated surgeries (58).
Please note the pathway to recruiting participants with dehisced wounds has changed 
to widen the recruitment reach. This does mean that participants seen in the 
community for dehisced wound will be eligible to join the study, the sites will be able to 
screen for participants using both pathways, whether seen in clinic by surgeon in 
charge or in the community.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 44 of 131
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This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
EXLUSION CRITERIA
Any one (1) of the following criteria will disqualify a potential subject from participation in the 
study:
1.
Contraindications (per the PICO 14 IFU) or hypersensitivity to the use of the investigational product or their 
components (e.g. silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives 
[direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the 
dressing).
2.
Subjects with extremely fragile skin who require the use of SECURA non-sting barrier skin wipes and have 
hypersensitivity to the ingredients in the wipes.
3.
Participation in the treatment period of another clinical trial within thirty (30) days of operative visit or during 
the study.
4.
Subjects with skin features (e.g. tattoos, skin colour, pre-existing scarring) which in the opinion of the 
Investigator, will interfere with the study assessments.
5.
Patients undergoing a procedure as part of palliative care.
6.
Subjects who have participated previously in this clinical trial and who have healed or been withdrawn. 
7.
Subjects with a history of poor compliance with medical treatment.
8.
Malignant wounds, open abdomen wounds which have been previously managed with NPWT in the previous 
four weeks.
10.
Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth 
control measures
11.
Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe 
subject participation in the study.
12.       Presence of infection as determined by the clinical signs and symptoms 
            (International wound infection59).
* Please see table below for clinical symptoms of infection as determined by the International Consensus update 
2016 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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Page: Page 45 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
SCREENING.
Participating study sites are required to document all screened subjects considered for inclusion 
in this study. If a subject is excluded from the study, the reasons for exclusion will be documented 
in the subject's source documents and noted on the Screening and Enrollment Log. All screening 
activities that occur prior to consent shall be referred to as pre-screening. 
Part of the screening process will include documentation of women’s childbearing potential. If the 
woman is not of childbearing potential this should be documented in the medical history (e.g.,
surgically postmenopausal, postmenopausal [i.e., at least one year without menses]). For women 
of childbearing potential, their method of birth control should be documented in the source. 
A screen failure is any subject who has signed a consent form and goes on to become ineligible 
for the study prior to the application of the study dressing (section 7.8.1 and 7.8.2). Information 
must be captured in the appropriate CRFs up to the point of screen failure with the reason for 
screen failure specified. Screen failures will be documented in the subject's source documents 
and on the Trial Register. Any screen failures will be replaced.
INFORMED CONSENT.
Before conducting any study procedures or examinations, the purpose and nature of the study will 
be explained to the subject in their native language. The subject, or their legally authorized 
representative, will then read, sign, and personally date the IRB/IEC approved informed 
consent document(s) (see below for difficulties with reading and writing). Additionally, the 
individual who obtains consent from the subject will sign and date the informed consent document. 
A copy of the signed informed consent documentation will be provided to the subject, a copy will 
be placed in the subject’s medical record, with the original filed in the ISF.
If the subject is unable to read, the informed consent document and associated study information 
may be read aloud to the subject in the presence of an impartial witness. If possible the subject 
shall sign and personally date the Informed Consent Form (ICF). Where this is not possible, due 
to difficulties in writing, the subject shall provide verbal consent to participate in the study. The 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 46 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
witness shall then personally sign and date the informed consent form, attesting that the 
information was accurately explained and that the informed consent was freely given.
All subjects will be given time to consider participation following the explanation of the 
study/reading of the patient information sheet. At least 24 hours will be needed before patient can 
consent to study. . No true emergency cases (where the subject is unconscious or does not have 
time to consider the study) will be consented for this study.
If the subject is unable to read, the informed consent document and associated study information 
may be read aloud to the subject in the presence of an impartial witness. If possible, the subject
shall sign and personally date the Informed Consent Form (ICF). Where this is not possible, due 
to difficulties in writing, the subject shall provide verbal consent to participate in the study. The 
witness shall then personally sign and date the informed consent form, attesting that the 
information was accurately explained and that the informed consent was freely given.
Due to COVID-19 pandemic verbal consenting might be required by sites to achieve consent from 
participants who are unable to attend at the time of consent. Process for this will involve, site to 
provide PIS and full information on the study at least 24 hours prior to the Verbal call and consent. 
Verbal consent will be sought and the consenter will date and sign the ICF on the participant 
behalf, the participant will be screened thereafter and once in clinic they will be asked to sign 
and date the ICF personally. In the case of emergency situations, the ICF may be obtained and 
information on the clinical study may be given after the decision to include the subject in the clinical 
investigation if the following situations apply:
Subject is unable to consent due to the form of wound (dehished wound only) in which 
wound becomes opened and dehishced and requires urgent treatment within hours of 
the wound being diagnosed as such by Investigator. Due to the time sensitivity of this 
cohort of participants, the risk is that this cohort might not be included in study if 
emergency consenting is not allowed. 
ICF will be obtained from the legally designated representative as soon as possible. In addition, 
informed consent to continue participation in the clinical investigation will be obtained from the 
subject as soon as the subject is capable to give informed consent.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 47 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
If the subject or the legally designated representative (if applicable) does not give consent, the 
subject or legally designated representative will be informed of the right to object to the use of 
data obtained from the clinical investigation.
If new information becomes available during the course of the study that can significantly affect 
a subject’s future health and medical care, Smith + Nephew will ensure that information shall be 
provided to the subject(s) affected in written form and if relevant, all affected subjects shall be 
asked to confirm their continuing consent in writing. 
ENROLLMENT.
Enrolment in this study shall occur at the point the consent process has been completed and 
study number is allocated to the subject.
LOST TO FOLLOW-UP.
A subject will be considered lost to follow-up if he/she does not appear for the scheduled study 
visit for 2 consecutive visits and does not return for a final visit, and study personnel are unable to 
contact the subject.
Some actively enrolled subjects will not return for follow-up exams on time. Study personnel must 
make a reasonable effort to contact the subject and document the following contact attempts 
before declaring a subject to be lost to follow-up: the subject has been contacted according to the 
site's policies, but no fewer than two documented phone contacts and one certified letter without 
response. Copies of all attempts to reach the subjects by mail or email and/or the attempts to 
contact the subject via other means should be documented, and that documentation should be 
kept with the subject’s source documents.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 48 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
WITHDRAWAL.
7.8.1    WITHDRAWAL OF TREATMENT.
Subjects may be withdrawn early from study treatment for the following reasons:
•
Subject does not return following treatment (and pump is lost).
•
Treatment is prematurely ended for any reason (i.e. due to removal of the system by the 
subject, failure of the pump, dressing falls off, seal can no longer be established).
•
Treatment is disrupted for longer than 24 hours (i.e. airtight seal was disrupted and was 
not re-established with a 24 hour time period).
•
At the discretion of the Investigator due to:
•
A change in treatment is clinically warranted (to include further treatment following 
14 day therapy)/28 day therapy for chronic wounds and dehisced surgical wounds.
•
An adverse event or device deficiency.
•
Any other significant reason identified by the Investigator.
7.8.2
WITHDRAWAL FROM STUDY.
The Investigator may withdraw subjects from the study for many reasons, including but not limited 
to the following:
subject noncompliance (e.g., did not follow instructions, took disallowed medications)
subject lost to follow-up
if the Investigator or the Sponsor stops the study for any reason and decides to withdraw 
subject(s) from the study
concurrent illness

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 49 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Adverse Events/Adverse Device Effects
any other significant reason identified by the Investigator
For each case, information will be obtained in the source document and the Case Report Form 
(CRF), detailing circumstances leading to the withdrawal. 
Subjects who are treated for with surgery that ends with a closed incision and subjects who drop 
out, or are withdrawn, will not be re-entered into the study at a later date.
7.8.3 SUBJECT’S WITHDRAWAL OF CONSENT TO PARTICIPATE IN STUDY.
Study participation is voluntary, and subjects may withdraw at any point during the study without 
giving their reason for doing so. Where subjects withdraw consent, the Investigator should make 
a reasonable effort to ascertain the reason(s), while fully respecting the subject’s privacy. The 
reason for withdrawal will be recorded in the CRF and source documents.
7.8.4
USE OF DATA FOLLOWING WITHDRAWAL.
In cases where the subject withdraws consent, the data collected up to the point of withdrawal 
may be used, but no additional data for that subject may be collected.
STUDY DESIGN
STUDY DESIGN.
This study is a prospective, multi-centre, non-randomised, non-blinded, single arm follow-up study 
to assess performance, safety and efficacy of PICO 14. It is anticipated that up to 7 sites will 
participate within Canada, UK and EU.
The treatment phase will be 14 days post-surgery with a 30 days study follow-up period/ up to 28 
days therapy period for chronic wounds and dehisced surgical wounds with no follow up. Fourteen 
days of therapy has been chosen as the length of time to assess device efficacy with use in real 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
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Version: 2.0, 12Sep2021
Page: Page 50 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
clinical conditions, since this is the length of time one system will operate and previous studies 
involving incisions suggest that benefit is generally achieved over 7-10 days of NPWT therapy. 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 51 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Figure 8.1-1: Study Flowchart – Schedule of PICO 14 therapy comparison and follow up 
for assessment of surgical site complications- Closed Incision only

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 52 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Figure 8.1-2: Study Flowchart – Schedule of PICO 14 therapy comparison and follow up 
for assessment of reference wound- Chronic wound and dehisced surgical wounds only

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 53 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
ALLOCATION AND BLINDING
8.2.1
Treatment Allocation
This study is not randomized.
8.2.2
Blinding
This study is non-blinded. 
DATA MANAGEMENT
This study utilizes a validated, 21 CFR Part 11 compliant, electronic data capture 
system. Access to the electronic data capture system is controlled through Smith 
and Nephew procedures. 
A Data Management Plan (DMP) is written according to Smith and Nephew 
procedures containing details of the data management process. The following is a 
brief description of the key points detailed in this plan. 
DATA REVIEW AND QUALITY ASSURANCE 
Data will be transcribed from the data source to an electronic Case Report Form 
(eCRF). All data requested on the eCRFs are considered required. Data points not 
collected and/or recorded will be considered deviations unless otherwise specified. 
Data collection is the responsibility of the clinical trial staff at the site under the 
supervision of the Principal Investigator. The Principal Investigator is responsible for 
ensuring the accuracy, completeness, legibility, and timeliness of the data reported. 
The Principal Investigator must provide his/her electronic signature on the 
appropriate eCRFs to be documented in compliance with local regulations. Changes 
to data previously submitted to the sponsor will require a new signature by the 
Investigator to acknowledge/approve the changes. 
Visual and computer data review will be performed in line with Smith and Nephew 
procedures to identify possible data discrepancies. Manual and automatic queries 
will be created within the electronic data capture system, and will be issued by 
Smith and Nephew to the site for appropriate response. Site staff are responsible for 
resolving all queries in the electronic data capture system. 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 54 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
RETENTION PERIOD
All eCRFs will be archived once the study is completed and will kept for a period of 
no less than five years after the later of the following dates: the date of which the 
study is terminated or completed or; the date that the records are no longer 
required supporting marketing applications.
STUDY ENDPOINTS.
8.6.1
PRIMARY ENDPOINT.
Functional clinical performance of the PICO 14 NPWT system over the treatment period to include: 
Delivery of -80mmHg negative pressure to the wound bed over the treatment period. This 
will be measured by download of the built-in data chip from the PICO 14 devices to collect 
NPWT delivery status.
Exudate management assessed by no occurrence of exudate leaks during the treatment 
period resulting, or not, in an unplanned dressing change.
8.6.2
SECONDARY ENDPOINTS.
Closed Incisions Only:
Clinical performance and safety of the PICO 14 NPWT system over a 14 day therapy and 30 day 
follow-up period to include:
Scar quality measured by POSAS score at Day 14, and day 30.
Incidence of Surgical Site Infection (SSI) and incidence of Surgical Site Complication 
(SSC) within 30 days of surgery [CDC criteria].
Condition of peri-wound skin assessed through visual inspection at 7, 14 and 30 days.
Level of pain on application, during wear and at dressing removal assessed by VAS scale 
over the 14 day treatment period.
Patient satisfaction during wear assessed over the 14 day period. This includes leakage, 
feeling of moisture on the skin, odour control, level of protection, comfort and showerproof 
qualities.
Ease of application and removal of the PICO 14 dressing.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 55 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Dressing wear time.
Dressing conformability
Dressing change frequency and reason for dressing change.
Clinician acceptability of PICO 14 system at discontinuation of therapy.
Patient acceptability of PICO 14 system at discontinuation of therapy.
Chronic wounds and dehisced surgical wounds only:
Clinical performance and safety of the PICO 14 NPWT system over a 28 day therapy and no 
follow-up period to include:
Incidence of clinical infection 
Appearance of the wound in terms of, tissue type and amount, exudate type and amount, 
skin condition surrounding the wound, peripheral tissue edema and induration, 
Condition of peri-wound skin assessed through visual inspection at 7, 14, 21 and 28 days.
Percentage reduction in area and volume from baseline to day 7, day 14, 21 and day 28. 
Level of pain on application, during wear and at dressing removal assessed by VAS scale 
over the 28 day treatment period.
Patient satisfaction during wear assessed over the 28 day period (for each treatment 
period). This includes overall performance of dressing, comfort, noise level, discreteness, 
portability, interference with daily living – showering, sleeping, socializing and working.
Ease of application and removal of the PICO 14 dressing.
Dressing wear time.
Dressing conformability
Dressing change frequency and reason for dressing change.
Clinician acceptability of PICO 14 system at discontinuation of therapy.
Patient acceptability of PICO 14 system at discontinuation of therapy.
8.6.3
OTHER ENDPOINTS.
No other endpoints.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 56 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
8.6.4
SAFETY ENDPOINTS.
Data will be collected on adverse events and device deficiencies during the study period.
METHODS USED TO MINIMIZE BIAS AND MAXIMIZE VALIDITY.
8.7.1
REDUCTION OF BIAS TOWARDS ACCEPTABILITY OF IP SYSTEM WHEN 
COMPARED WITH OTHER MANUFACTURERS/MODELS
Smith+Nephew will ensure that reduction of bias towards acceptability of the PICO 14 system 
against any others marketed, by being fully transparent with the aim of the study prior to 
commencing and through publishing the result of the primary endpoint following reporting on 
www.clinicaltrials.gov and any other applicable trial registries.
STUDY PROCEDURES - CLOSED INCISIONS ONLY.
VISITS AND EXAMINATIONS.
Summary
For a summary of the required procedures by visit, refer to the Study Schematic Table 13.1-1: 
Study Procedures by Visit.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 57 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
                          Table 9.1-1: Study Procedures by Visit- Closed Incisions ONLY.
Schedule of events 
Pre-
Operative
Data
Operative  
Data
DAY 0
DAY 7 
Visit (-3 
days)
End of 
therapy 
assessmen
t 
DAY 14 (-2 
days)
Exit visit
DAY 30 (±3 
days)
Additional 
dressing 
change
(Day 1-13)
Unscheduled 
Visit or Early 
Exit
Informed Consent
X
Inclusion/Exclusion 
X
X
Demographics/ Medical 
History
X
X
Incision assessment
X
X
X
X
X
Dressing assessment 
X
X
X
X
Complications assessment
X
X
X
X
X
X
Photographic assessment
X
X
X
X
X
X
Operative Collection
X
X
POSAS
X
X
Concomitant Medication
X
X
X
X
X
X
X
Dressing application
X
X
Return to 
standard care
X
X
Dressing removal 
Assessment 
X
X
X
X
Patient and clinician 
acceptability questionnaire 
completion 
X
X
X
X
Discharge Data Collection, if 
applicable
X
Adverse Event Assessment
X
X
X
X
X
X
X
Device Deficiency 
Assessment
X
X
X
X
X
End of Study/Exit  
X
X

Study Protocol—Device
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management of acute and chronic wounds
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Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
9.1.1
SCREENING/PREOPERATIVE VISIT (MAY BE UP TO 4 WEEKS PRIOR TO VISIT).
NOTE: Any subject who signs an informed consent/assent but fails to meet the required entry criteria is considered 
to be a Screen Failure. Screen Failure subjects will be assigned subject numbers and ONLY the screening visit and 
their demographic information must be captured in the appropriate CRF with the reason for screen failure specified.
1.
Obtain written informed consent from the subject as detailed in Section 7.5.
----- Do not proceed until consent has been obtained -----
2.
Obtain demographic information and medical history, including information on all concomitant 
medications/therapies.
3.
Screen the subject for protocol inclusion/exclusion criteria.
4.
Subjects will be instructed to return to the treatment facility for the Operation Visit (within 4 weeks of 
consent).

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
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Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
9.1.2
BASELINE OPERATIVE VISIT (WITHIN 4 WEEKS OF SCREENING) - CLOSED INCISIONS 
ONLY.
1.
Query subject regarding any changes in general health and the use of concomitant medications.
2.
Commence operation and collect surgery data [e.g. Type of surgery (closed surgical incision, 
(type of abdominal surgery / type of knee surgery, method of closure), and reference wound type.
3.
Collect surgery risk factors (elective/emergency surgery, laparoscopic (y/n), incision length, use of 
prophylactic antibiotics, type (single / double / triple agent) and when administered (prior to start of 
surgery/after surgery began), shaving of incision (yes / no / not needed), use of a wound protector 
(yes / no), clean/contaminated surgery (clean/clean-contaminated/contaminated/dirty), 
intraoperative warming (yes / no)).
4.
Confirm eligibility following surgery details.
Assign a study number to the subject (XX.YYY where XX = site number and YYY =subject 
number at the site).
5.
Assess the incision characteristics for likelihood of SSC (oedema, seroma, haematoma, skin 
necrosis).
6.
Assess the surrounding skin (e.g., healthy, fragile, inflamed, erythema, bruising, eczematous, 
dry/flaky, macerated).
7.
Photograph incision using the camera provided by the Sponsor showing the photo label as 
supplied. 
8.
Dispense study product. Record pump lot number, size of dressing used and any ancillary 
products applied (SECURA No-Sting Skin prep, RENASYS Adhesive Gel Patch).
9.
Assess ease of application, ease of establishing seal/negative pressure delivery, satisfaction of 
applying IP.
10.
Take photograph of dressing in place.
11.
If any adverse device effects or device deficiencies are observed or reported, they must be 
recorded as instructed in Section 12 - Adverse events and device deficiencies.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 60 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
9.1.3
DAY 7 (-3 DAYS) FOLLOW UP DRESSING INSPECTION
1.
Record date and treatment setting. If outpatient, record date of previous discharge.
2.
If therapy is being discontinued prior to 7 days or dressing is no longer in place, 
complete the End of Therapy Assessment (9.1.6 below).
3.
Record if therapy has been interrupted since the previous assessment and how 
long.
4.
Record the use of concomitant medications.
5.
Take photograph of dressing in place.
6.
Assess subject comfort (yes, no) and pain level (Visual Analogue Scale).
7.
If dressing change is required then please follow additional dressing study 
procedures.
8.
If any adverse device effects or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 12 - Adverse events and device 
deficiencies.
9.
Instruct the subject on follow-up procedures, including returning to the treatment 
facility for the End of Therapy Assessment Visit at 14 (-2) days post-surgery.
9.1.4
END OF THERAPY ASSESSMENT DAY 14 (-2) DAYS.
1. Record date and treatment setting. If outpatient, and not previously recorded, record 
date of previous discharge.
2. If therapy is being discontinued prior to 14 days, record reason (e.g. PICO 14 NPWT 
system removed, treatment interrupted for 48 hours or more, clinician recommends a 
change in treatment, at the discretion of the Investigator, adverse event, subjects own 
request, lost to follow-up, other). If pump is faulty change is permissible during 
therapy period record the reason under Device deficiency CRF form.
3. Record the use of concomitant medications.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 61 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
4. Record reason if dressing is no longer in place (e.g. pain/discomfort from the 
dressing, patient removed, patient’s request, adverse event, no vacuum, pump turned 
off, reason for dressing change and exudate management data collection, other).
5. Take photograph of dressing in place.
6. Record if therapy has been interrupted since the previous assessment and how long.
7. Assess subject satisfaction (overall performance of dressing, comfort, noise level, 
discreteness, portability, interference with daily living – showering, sleeping, 
socialising, working).
8. Remove NPWT system as per procedure (section 9.2.4).
9. Assess ease of removal.
10 Record pain score (VAS) and patient comfort since last assessment and pain score 
on dressing removal.
11 A suitably qualified individual (as described in section 9.2.1) to complete assessment
of incision. If any complications have occurred, details of this and additional 
procedures to be collected (9.1.9).
12 Assess the surrounding skin (e.g., healthy, fragile, inflamed, erythema, bruising, 
eczematous, dry/flaky, macerated).
13 Photograph the incision using the camera supplied by the Sponsor.
14 If any adverse device effects or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 12 - Adverse events and device 
deficiencies.
15 Follow procedure for removal, appropriate labelling and storage of pump for return to 
S&N.
16
  17
Assess clinician acceptability of PICO NPWT system (Overall satisfaction, satisfaction 
with ability to manage incision/, satisfaction regarding dressing retention, satisfaction 
as compared to other NPWT devices).
Complete POSAS at this visit.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 62 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
9.1.5
EXIT VISIT 30 (±3) DAYS- CLOSED INCISIONS ONLY.
1. A suitably qualified individual (as described in section 9.2.1) to complete assessment 
of incision complications. If any complications have occurred, details of this and 
further to be collected (as per 9.1.10).
2. Assess the surrounding skin (e.g., healthy, fragile, inflamed, erythema, bruising, 
eczematous, dry/flaky, macerated).
3. Photograph wound using camera provided by Sponsor.
4. If any adverse device effects or device deficiencies are observed or reported, they must 
be recorded as instructed in Section 12 - Adverse events and device deficiencies.
5. Complete Exit Visit CRF and complete POSAS.
9.1.6
ADDITIONAL DRESSING CHANGE ASSESSMENT (DAY 1-13) - CLOSED INCISIONS ONLY.
PICO 14 is intended to be used for up to 14 days. Additional dressing change assessments will be 
completed if the dressing needs changing prior to Day 14 post surgery.
1. Record date and treatment setting. If outpatient, and not previously recorded, record 
date of previous discharge.
2. Record reason for dressing change (e.g. routine, dressing saturated (exudate), 
strikethrough, leakage, pain, loss of vacuum, dressing got wet during shower/bathing, 
inspection prior to patient discharge, patient removed dressing, patient’s request, other).
3. Record the use of concomitant medications.
4. Record reason if dressing is no longer in place (e.g. pain/discomfort from the dressing, 
patient removed, patient’s request, adverse event, no vacuum, pump turned off, other).
5. Record if therapy has been interrupted since the previous assessment and how long.
6. Take photograph of dressing in place.
7. Assess subject satisfaction (overall performance of dressing, comfort, noise level, 
discreteness, portability, interference with daily living –
showering, sleeping, 
socialising, working).

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 63 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
8. Remove NPWT system as per procedure (section 9.3) for data chip collection.
9. Assess ease of removal.
10 Record pain score (VAS) since last assessment and on dressing removal.
11 A suitably qualified individual (as described in section 9.2.1) to complete assessment 
of wound complications. If any complications have occurred, details of this and 
additional procedures to be collected (per section 9.1.10).
12 Assess the surrounding skin (e.g., healthy, fragile, inflamed, erythema, bruising, 
eczematous, dry/flaky, macerated).
13 Photograph the incision/ using the camera supplied by the Sponsor.
14 Dispense study product. Record pump lot number, size of dressing used and any 
ancillary products applied (SECURA No-Sting Skin prep, RENASYS Adhesive Gel 
Patch).
15 Assess ease of application, ease of establishing seal/negative pressure delivery, 
satisfaction of applying IP.
16 Take photograph of dressing in place.
17 If any adverse device effects or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 12 - Adverse events and device deficiencies.
18 Instruct the subject on follow-up procedures, including returning to the treatment facility 
for the next scheduled assessment.
9.1.7
UNSCHEDULED - SSC ASSESSMENT.
Unscheduled examinations may be conducted at the discretion of the Investigator with all obtained information 
recorded in the source documents and on the appropriate CRF. An unscheduled visit will be a visit that is not within 
the visit window for baseline, day 7 follow up and end of therapy assessment, visits. If an unscheduled visit occurs 
within 14 days post-start of treatment a new PICO 14 dressing may be applied to the incision if clinically warranted.
All information obtained during an unscheduled visit should be recorded in the source documents 
and on the appropriate CRF.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 64 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
9.1.8
CONCOMITANT MEDICATIONS AND THERAPIES.
A concomitant medication (e.g. drug, substance) and a concomitant therapy (e.g. physical therapy, TENS Unit, 
massage) are recorded at any time from enrolment into the study through the subject’s last study visit, including 
ongoing medications. 
9.1.8.1
CONCOMITANT MEDICATIONS.
9.1.8.1.1          EXCLUDED CONCOMITANT MEDICATIONS.
The following concomitant medications are not permitted from the time of entry into the study until the exit visit has 
taken place:
1.
Record the date that the complication occurred.
2. 
Record the complication type (e.g. superficial infection i.e. cellulitis, deep infection, 
organ/space infection, oedematous, seroma, haematoma, abscess, discharge 
(serous exudate with inflammation, seropurulent, haemopurulent, pus), delayed 
healing, discoloration, unexpected pain/tenderness/bridging of the epithelium or soft 
tissue, abnormal smell, wound breakdown, severe bruising, superficial dehiscence, 
deep dehiscence, other).
3. 
Record procedure (e.g. opening of wound, drainage of wound infection, antibiotics—
oral, antibiotics—intravenous, re-suture of wound, evacuation of hematoma, seroma 
aspiration, incision of an abscess, wound toilet, negative pressure wound dressing—
cavity, change to antimicrobial or antibacterial treatment, other) / treatment changed 
to treatment changed to (e.g. a different NPWT system, simple foam dressing, 
antimicrobial dressing, other). 
4.
Record any concomitant medications.
5.
The complication and any device deficiencies must be recorded as instructed in 
Section 12 - Adverse events and device deficiencies.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 65 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
No other ointments/gels/topical lotions/creams should be used with the PICO system as per the IFU 
(other than the SECURA skin barrier wipes and RENASYS Adhesive Gel Patches provided as ancillary 
for the study).
9.1.8.1.2          RECORDING CONCOMITANT MEDICATIONS IN THE CRF.
All medications will be recorded in the CRF. Refer to the CRF Completion Guidelines for how medications are 
recorded. 
9.1.8.1.3          THERAPIES PROHIBITED DURING THE STUDY.
The use of the following concomitant therapies is not permitted during the study period:
•       No dressings (i.e. foam, gauze, ACTICOAT) should be used under the IP during therapy. Please note it is 
acceptable to use foam or gauze fillers.
•
No other NPWT devices (i.e. RENASYS, Vac) should be used following the 7 day therapy treatment period 
unless it becomes necessary on clinical grounds and this would be the routine clinical protocol provided by 
the site.
9.1.8.2
RECORDING CONCOMITANT THERAPIES IN THE CRF.
Only therapies related to (directly treating) the reference incision will be recorded on the CRF. Refer to the CRF 
Completion Guidelines for how concomitant therapies are recorded.
9.1.9
DISCONTINUED SUBJECTS.
Discontinued subjects are those who voluntarily discontinue participation or who are lost to follow-up refer to section 
5.8 for further details. Where possible, a full Exit Visit should be completed for all subjects who discontinue the 
study early. Where consent is withdrawn, the date and any reason given for discontinuation should be captured, at 
a minimum (see Section 5.8.2).
Finally, if appropriate, the Investigator will also advise the subject of subsequent therapy and/or procedures 
necessary for their medical condition. 
Subjects who are withdrawn only from treatment will not automatically discontinue participation in the study, see 
Section 5.8.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 66 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
9.1.10
SUBJECT PREGNANCY.
Women of child-bearing potential are excluded from the study. However, if a woman becomes pregnant during the 
study, S&N must be contacted immediately once the investigator is made aware of the pregnancy and subject will 
be withdrawn from study. Pregnancy is not an adverse event; however, complications related to the pregnancy may be 
reportable as determined on a case-by-case basis. Pregnancy-related information will be collected until the end of the 
pregnancy
STUDY METHODS AND MEASUREMENTS.
9.2.1
INCISION CLOSURE AND CDC INCISION ASSESSMENT.
A medically qualified individual who is not deemed to have a vested interest in low reporting of complications and 
infections at an institutional level will complete incision assessment. This will include i) an assessment of whether 
the incision is fully closed/epithelialised an assessment of delayed healing, iii) an assessment of infection, 
dehiscence or other complications. 
Incision closure is defined as skin closure (100% closed) without drainage or dressing requirements. Primary or 
first intention healing occurs when tissue is cleanly incised and re-approximated and healing occurs without 
complications. Incisional wounds are usually completely sealed in 24-48 hours, with continued healing of the 
underlying structures within 5-7 days. Delayed wound healing would be defined as an incision that is not closed, or 
“parts” unhealed, >7 days.
Assessment of incision infection will be completed as specified per the CDC definitions of nosocomial surgical site 
infections at each of the specified time points to identify whether there is superficial, deep, or organ/space infection 
at the incision site. Infection is defined as “the presence of one or more of the following criteria; abscess, cellulites, 
discharge, (serous exudate with inflammation, seropurulent, haemopurulent, pus) delayed healing, discoloration, 
unexpected pain/tenderness/bridging of the epithelium or soft tissue, abnormal smell, or wound breakdown”. This 
can occur with or without the signs of leukocytosis and fever”. Cutting K F et al. 24, (2004).
If dehiscence has occurred, the level of dehiscence will be defined as superficial (involve only separation at skin 
level) or deep (involve separation of tissues below the skin, may or may not include skin separation). 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 67 of 131
CONFIDENTIAL AND PROPRIETARY
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Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
A training session will be held for the individuals at each site to standardise how the assessments of complication, 
infection and dehiscence are made.
Surgery details to be collected include the following questions:
Date of surgical procedure (DD/MMM/YYYY).
Collect surgery data [e.g. Type of surgery (closed surgical incision, (type of abdominal surgery / type of knee 
surgery, method of closure), and reference wound type and anatomical site).
Collect surgery risk factors (elective/emergency surgery, laparoscopic (y/n), incision length, use of 
prophylactic antibiotics, type (single / double / triple agent) and when administered (prior to start of 
surgery/after surgery began), shaving of incision (yes / no / not needed), use of a incision drape (yes / no), 
clean/contaminated surgery (clean/clean-contaminated/contaminated/dirty), intraoperative warming (yes / 
no)).
To be collected for each incision:
Closure method (sutures / staples / surgical glue / adhesive strips / other).
Types of sutures used (nylon / polypropylene / vicryl / monocryl / other).
Suture closure technique (simple interrupted stitch / horizontal mattress / vertical mattress / figure 8 / 
continuous locking / sub-cuticular / other).
Have any drains been used (Yes / No. If Yes, number of drains used, level of exudate contained in drain 
(ml)).
Duration of surgery (mins).
Incision information to be collected include the following questions.
To be completed for each incision:
Questions asked at surgery visit only
Measure of length/size of incision (cm) – (horizontal / vertical / NA).
Incision Characteristics – (Normal / Oedematous / Seroma / Hematoma / Dehiscence/ Skin Necrosis / Other).

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 68 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Questions asked at all assessments except the surgery visit
Level of exudate (none / light / moderate / heavy).
Colour of exudate (serous / serosanguinous /sanguineous / tan / purulent /other).
Level of post-surgical swelling (none / slight / moderate / severe).
Level of bruising (none / light / moderate / severe / extreme-critical).
Bruising site (other-please specify).
Condition of surrounding skin (Healthy / Fragile / Inflamed / Erythematous / Oedematous / Eczematous /
Macerated / Bruising / Dry & Flaky / other).
Incision closed (healed)? (Yes / No).
o
If no:
Incision dehisced (Yes / No. If yes, superficial / deep / partial / length (cm)).
Length/parts unhealed, estimation of length/parts unhealed (cm) – (vertical/horizontal).
Incision clinically infected (Yes / No. If yes, deep or superficial infection).
Clinical signs of infection (none / increased exudate-secretion levels / increased pain / increased 
temperature around the incision / tissue necrosis / local erythema / oedema / purulent drainage / dehiscence 
/ odour / other).
Assessment of incision complications (None / Superficial Infection (i.e. Cellulitis) / Deep Infection / 
Organ/Space Infection / Oedematous / Seroma/ Haematoma /  Abscess / Skin Necrosis Partial Dehiscence 
/ Total Dehiscence/ Superficial Dehiscence / Deep Dehiscence / Suture Abscess or Extrusions / Delayed 
Healing / Discolouration / Unexpected pain/tenderness/Abnormal smell / Wound breakdown / Other).
Additional procedures performed (None / Debridement / Removal of Sutures (or clips) / Opening of incision 
/ Drainage of incision infection / Antibiotics – Oral / Antibiotics – Intravenous / Re-suture of incision / l / 
Evacuation of hematoma / Seroma Aspiration / Incision of an Abscess / Debridement /  Treatment changed 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 69 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
/ Other. If treatment changed, A different NPWT system / Absorbent dressing / Antimicrobial dressing / 
other).
Incision relief (normal / flat / raised).
Incision colour (pale / white / pink / red / purple / mix).
Level of itching from the incision (none / slight / moderate / severe).
Question asked at assessments from Treatment Discontinuation to Day 30 for each incision
List any dressings that have been applied to the incision since the previous assessment (None / Steri-strips 
/ Foam dressing / Films/polymer dressing / Alginate/Hydrofiber/ Antimicrobial dressings (silver/iodine) / 
Hydrocolloid / Non-adherent dressing / Odour absorbent dressing / Absorbent pads / Bandages / Hydrogels 
/ Gauze / Other).
9.2.2
ASSESSMENT OF PERI-WOUND SKIN.
The surrounding skin will also be assessed by the above mentioned clinician. The clinician whether the skin appears 
healthy or is fragile, inflamed, eczematous, dry/flaky, macerated or has erythema, bruising.
9.2.3
SURGICAL SITE AND DRESSING PHOTOGRAPHS.
An image of the subject’s postsurgical incision  will be captured prior to initial dressing application, at 7 days post 
operatively (or when dressing is removed) and at end of therapy at 14 days and 30 days postoperatively (or early 
exit visit) using a digital camera supplied by S&N. The images will be used as a pictorial record of the study 
reference incisions. 
A photo ruler labelled with the subject’s number, study number and the date will be supplied by S&N and will be 
placed in the field of the photograph. The image should be framed such that the entire incision/dressing nearly fills 
the frame. Ensure that identifying information, such as the subject’s face, are not visible in the photograph. After 
obtaining the image, ensure that the image is clear (in focus) and that there is sufficient light to clearly see the 
incision/dressing. Instructions for capturing images will be supplied with the cameras. Training on the use of the 
camera will be given during the site initiation visit.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 70 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
An image of the dressing in place will be taken after application, and before removal, to check the device 
compliance.
If an AE or any other change to the subject’s surgical site occurs during the study, further images of the wound will 
be captured to document the event if there is visible impact of the AE or other change. A photograph should also 
be taken where appropriate of all DevD reported.
All photographs should be uploaded to the relevant assessment on the CRF.
9.2.4
DRESSING APPLICATION ASSESSMENT.
Dressing Application information to be collected include the following questions. 
To be completed for each incision (Day 0 – Treatment Discontinuation): 
Any products applied at dressing application (None/ SECURA No-Sting Barrier Film wipes / RENASYS 
Adhesive Gel Patch / topical antibiotics / other). Reduce bioburden, Lower risk of infection, other.
o
Renasys gel patch used (Yes/No).
-
If used how long did the patch last for, and any problems upon removal. 
-
Did the Renasys gel patch provide comfort to the subject’s incision wound.
PICO 14 UDI Number 
PICO 14 pump Lot Number and Catalogue number will also be collected. 
If Dressing used is separate to what is provided in the PICO14 kit please record UDI, Lot and Catalogue 
number of the dressing.
Size of PICO 14 NPWT dressing kit size used (10 x 20 cm / 10 x 30 cm / 10 x 40 cm / 15 x 15 cm / 15 x 20 
cm / 15 x 30 cm / 20 x 20 cm / 25 x 25 cm / Small Multisite / Large Multisite).
-
Was the dressing used on the closed incision wound conformable (Yes/No)

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 71 of 131
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written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
If No, please comment.
Easy to create a vacuum on the PICO dressing (Yes / No).
Easy to operate the pump on the PICO dressing (Yes / No).
Dressing application on incision:
o
Dressing easy to apply (Yes / No).
o
Satisfaction with the application of the PICO dressing (Yes / No).
o
Dressing comfortable (Yes / No) (not on day of surgery)
Question asked at all assessments from Treatment Discontinuation to Day 30 for each incision
List the dressings that has been applied to the incision at this assessment (None / Steri-Strips / Foam 
dressing / Films/polymer dressing / Alginate/Hydrofiber / Antimicrobial dressings (silver/iodine) / Hydrocolloid 
/ Non-adherent dressing / Odour absorbent dressing / Absorbent pads / Bandages / Hydrogels / Gauze / 
Other).
9.2.5
DRESSING REMOVAL ASSESSMENT (AT DAY 14, ALSO APPLICABLE IF DRESSING HAS TO BE 
CHANGED BEFORE DAY 14).
Dressing removal information to be collected include the following questions: 
To be completed for each incision:
Subject treatment setting (In-patient / Out-patient /other).
Subject discharged from hospital since the last assessment (Yes / No / NA. If yes, date of discharge).
Has the subject been re-admitted to hospital since the last assessment as a result of their surgery (Yes / 
No. If yes, date of re-admission).
Additional procedures carried out (Yes / No. If yes, please provide details).
Dressing comfortable during wear (Yes / No. If no, please comment).
Dressing acceptable to the patient (Yes / No. If no, please explain).

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 72 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Acceptable dressing exudate management (Yes / No. If no, please comment).
Level of pain from the incision since the last assessment (0-10 scale).
Reason for dressing change (Routine/ inadequate exudate management / pain-discomfort from the dressing 
/ dressing damaged / dressing fell off / patient removed dressing / adverse event / surgical procedure / safety 
alarm / dressing components not in place / no vacuum /other).
Is the dressing still covering the incision as applied? (Yes / No).
How long has the dressing not covered the incision? (Day / Hour / Min) if applicable.
Has the dressing been removed at any point since application? (Yes / No).
How long was the dressing not in place? (Day / Hour / Min).
Has there been any period that the vacuum was not applied during therapy apart from showering? (Yes / 
No. If yes, for how long).
Level of Pain on removal of dressing (0 -10 scale).
Was the dressing easy to remove? (Yes / No. If no, please comment).
9.2.6
TREATMENT DISCONTINUATION.
Treatment discontinuation information to be collected include the following questions:
Date of treatment discontinuation.
Reason for treatment discontinuation (End of treatment period (14 days) / Vacuum interrupted for > 48 
hours / A change in treatment is clinically warranted / Subject withdrawn—Adverse Event / Other 
(specify). If Incision management complete. 
Overall subject assessment of PICO 14:
o
How was the pump carried around (Pump Clip / Pocket / Hand / Other? If other, please state). 
If the Pump Clip used, was the clip a useful feature (Yes/No. If No, why).
o
Subject satisfaction with the following aspects of the NPWT system: Overall performance, 
Comfort during wear, Noise Level, Discreetness, Portability (Scale).

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 73 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
o
Interference with daily living – Showering, Sleeping, Socialising, Working  (Yes, please 
comment/ No)
Overall investigator assessment of PICO 14:
o
Overall is the Investigator satisfied with the performance of the PICO 14 system (pump and 
dressing) (Yes / No. If No please comment).
o
Following questions will be asked :"Are you satisfied with the PICO 14 systems ability to 
manage wound/ incision?", Are you satisfied with the PICO 14 systems ability regarding 
dressing retention?" and "Are you satisfied with the PICO 14 systems ability when compared to 
other NPWT devices?"
9.2.7
SUBJECT EXIT.
Subject exit information to be collected include the following questions,
Date of Subject Exit.
Reason for Subject Exit (End of Follow Up period (30 days) /  Subject Withdrawn – Non-compliance / 
Subject Withdrawn – Adverse Event / Subject Withdrawn – Subject’s own request / Subject Withdrawn 
– Lost to follow-up / Investigator Decision / Other (Specify)).
Complete of POSAS and exit questionnaire. 
PICO 14 DEVICE RETURN.
All PICO 14 pumps will be returned to S&N for download of the in-built data chip. Once the pumps have been 
removed from the subject they are to be decontaminated using the following procedure:
Label a zip-locked bag with subject ID number, initials and date labelled.
At the Treatment Discontinuation Assessment the PICO dressing will be removed from the subject in order 
to inspect the surgical site as per the study protocol.
The PICO dressing will be disconnected from the pump and the dressing disposed of as clinical waste.
The surface of the pump should be wiped with a disinfectant wipe. Remove and retain the batteries. Clean 
the batteries and the inside of the battery compartment with a disinfectant wipe.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 74 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Put the PICO pump and the batteries in the labelled bag.
During the monitoring visits, the study monitor will count the devices and verify that they have been labelled 
correctly, collect devices and shipment will be arranged to Smith+Nephew Wound Management, Hull, UK.
In an identified handling area at Smith+Nephew Wound Management, Hull, UK, the devices shall be processed to 
have their internal memory contents downloaded, analysed and saved following an approved NPD (New Product 
Development) Work Instruction.
HEALTH ECONOMICS/QUALITY OF LIFE.
No Quality of Life Questionnaires will be collected for this study however, assessment of acceptability of the therapy 
will be made by specific targeted questions to the clinician and subject as described in section 9.2.5 above.
SCAR QUALITY ASSESSMENT (AT DAY 0, DAY 14 AND AT EXIT VISIT).
The Patient and Observer Scar Assessment Scale (POSAS) is a comprehensive scale that is designed for the 
evaluation of all types of scars by professionals and patients. The POSAS aims to measure scar quality. The Patient 
Scale gives the POSAS an important extra dimension because the patient’s opinion is mandatory for a complete 
scar evaluation. The Observer Scale will be completed by an independent member of the study team.
The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are 
scored numerically and make up a ‘Total Score’ of the Patient and Observer Scale. The sum altogether will give the 
‘Total Score’ of the POSAS. Besides the 10-step scale, category boxes are available to score nominal parameters 
(e.g. type of colour). Moreover, the patient and observer also score their ‘Overall Opinion’.
Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest 
score is ‘1’, and corresponds to the situation of normal skin (normal pigmentation, no itching etc.), and goes up to 
the worst imaginable. The Total Score of both scales can be simply calculated by summing up the scores of each 
of the six items. The Total Score will therefore range from 6 to 60. Besides the six items the ‘Overall Opinion’ of the 
scar quality is scored separately of both patients and observers.
A full description of the Patient and Observer Scar Assessment Scale can be found in appendix 22.5.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 75 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
STUDY PROCEDURES- CHRONIC WOUNDS AND DEHISCHED SURGICAL WOUNDS ONLY.
VISITS AND EXAMINATIONS.
10.1.1 SUMMARY.
For a summary of the required procedures by visit, refer to the Study Schematic Table 10.1-1: Study Procedures 
by Visit.
Table 10.1-1: Study Procedures by Visit- Chronic wounds and dehisced surgical wounds ONLY.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 76 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Schedule of events 
Pre-
Treatment
Data
Treatmen
t Data
DAY 0
DAY 7 
Visit (-3 
days)
DAY 14 
Visit (-2 
days)
Day 21 
Visit (-3 
days)
End of 
therapy and 
Exit visit
DAY 28 (-3 
days)
Additional 
dressing 
change
(Day 1-27)
Unscheduled 
Visit or Early 
Exit
Informed Consent
X
Inclusion/Exclusion 
X
X
Demographics/ Medical 
History
X
X
Wound Assessment 
(including 
measurement)
X
X
X
X
X
X
Dressing assessment 
X
X
X
X
X
Complications 
assessment
X
X
X
X
X
X
X
Photographic 
assessment
X
X
X
X
X
X
X
Treatment Data 
Collection
X
X
X
X
X
Concomitant 
medication
X
X
X
X
X
X
X
X
Dressing application
X
X
X
X
Return to 
standard 
care
X
X
Dressing removal 
Assessment 
X
X
X
X
X
X
Patient and clinician 
acceptability 
questionnaire 
completion 
X
X
X
X
X
X
Adverse Event 
Assessment
X
X
X
X
X
X
X
X
Device Deficiency 
Assessment
X
X
X
X
X
X
End of Study/Exit  
X
X

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 77 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
10.1.2 SCREENING VISIT/BASELINE VISIT.
NOTE: Any subject who signs an informed consent/assent but fails to meet the required entry criteria is 
considered to be a Screen Failure. Screen Failure subjects will be assigned subject numbers and ONLY the 
screening visit and their demographic information must be captured in the appropriate CRF with the reason for 
screen failure specified.
1. 
Obtain written informed consent from the subject as detailed in Section 7.5.
----- Do not proceed until consent has been obtained -----
2.
Obtain demographic information and medical history, including information on all 
concomitant medications/therapies. 
3.
Screen the subject against eligibility criteria and assign a study number to the subject 
(XX.YYY where XX= site number and YYY= subject number at site.
4.
Instruct the subject on treatment procedures.
5.
Complete a full wound assessment sections (10.4.2). 
6.
Take a photograph of the reference wound showing the photo label as supplied.
7.
Product/therapy used prior to study.
8.
Assess the peri-wound skin.
9.
Take a photograph of the reference wound showing the photo label as supplied 
(section 10.4.3).
10.
Dispense study product. Record pump lot number, size of dressing used and any 
ancillary products applied (SECURA No-Sting Skin prep, RENASYS Adhesive Gel 
Patch).
11.
Take photograph of dressing in place by camera supplied by Sponsor and add label 
supplied.
12.
VAS score will be recorded upon product application.
13.
Assess ease of application, ease of establishing seal/negative pressure delivery, 
satisfaction of applying IP.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 78 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
14.
If any AE or DevD are observed or reported, they must be recorded as instructed in 
Section 12, Adverse Events and Device Deficiencies. Take a photograph of the 
wound/dressing as appropriate.
15.
Instruct subject of the follow up visit at day 7 (-3 days).
10.1.3 DAY 7 (-3 DAYS) FOLLOW UP DRESSING INSPECTION.
1.
Record date and treatment setting.
2.
If therapy has been discontinued prior to this visit or dressing is no longer in place, complete the End of 
Therapy Assessment (10.1.5below).
3.
Record if therapy has been interrupted since the previous assessment and how long.
4.
Record any changes in general health and record the use of concomitant medications.
5.
Take photograph of dressing in place by camera supplied by Sponsor and add label supplied.
6.
Dressing removal assessment.
7.
Assess the peri-wound skin.
8.
Complete a full Wound Assessment (section 10.4.2).
9.         Take photograph of the wound site area.
10.
A new dressing will be applied and the PICO14 pump will be restarted to apply for up to 7      
           days.
11.      Take photograph of new dressing in place.      
12.           Assess subject comfort (yes, no) and pain level (Visual Analogue Scale).
13.
If any adverse device effects or device deficiencies are observed or reported, they must be recorded as 
instructed in Section 12 - Adverse events and device deficiencies. Take a photograph of the 
wound/dressing as appropriate.
14.
Instruct the subject on follow-up procedures, including returning to the treatment facility for the 
Assessment Visit at 14 (-2) days. Record date of assessment.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 79 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
10.1.4 ASSESSMENT VISIT DAY 14 (-2) DAYS.
1.
Record date and treatment setting. 
2. 
If therapy is being discontinued prior to 14 days, record reason (e.g. PICO 14 NPWT 
system removed, treatment interrupted for 48 hours or more, clinician recommends a 
change in treatment, at the discretion of the Investigator, adverse event, subjects own 
request, lost to follow-up, other).
3.
Record reason if dressing is no longer in place (e.g. pain/discomfort from the 
dressing, patient removed, patient’s request, adverse event, no vacuum, pump turned 
off, exudate management level, other).
4. 
Take photograph of dressing in place.
5.
If any AE or DevD are observed or reported, they must be recorded as instructed in 
Section 12, Adverse Events and Device Deficiencies. Take a photograph of the 
wound/dressing as appropriate.
6.
Record any changes in general health and the use of concomitant medications.
7. 
Record if therapy has been interrupted since the previous assessment and how long.
8.
Complete the Dressing Removal Assessment.
9. 
Complete a full Wound Assessment (section 10.4.2).
10.
Assess the peri-wound skin.
11.
Assess subject satisfaction (overall performance of dressing, comfort, noise level, 
discreteness, portability, interference with daily living – showering, sleeping, 
socialising, working).
12.
Assess clinician and participant acceptability of PICO NPWT system (Overall 
satisfaction, satisfaction with ability to manage, satisfaction regarding dressing 
retention, satisfaction as compared to other NPWT devices).Record date of 
assessment.
13.
Remove NPWT system and re-apply new PICO 14 device onto same wound.
14.
Assess ease of removal.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 80 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
15.
Record pain score (VAS) and patient comfort since last assessment and pain score 
on dressing removal.
16.
Photograph wound area using the camera supplied by the Sponsor.
17.
Follow procedure for removal, appropriate labelling and storage of pump for return to 
S&N.
18.
Dispense study product. Record pump batch number, size of dressing used and any 
ancillary products applied (SECURA No-Sting Skin prep, RENASYS Adhesive Gel 
Patch).
19.
Take photograph of the new dressing in place.
20.
Assess ease of application of new dressing.
21.
Instruct the subject on follow-up procedures, including returning to the treatment 
facility for the Assessment Visit at 21 (-2) days. Record date of assessment.
10.1.5 DAY 21 (-3 DAYS) FOLLOWUP DRESSING INSPECTION
1.
Record date and treatment setting.
2.
If therapy is being discontinued prior to 21 days or dressing is no longer in place, complete the End of 
Therapy Assessment (10.1.5 below).
3.
Record if therapy has been interrupted since the previous assessment and how long.
4.
Record any changes in general health and record the use of concomitant medications.
5.
Take photograph of dressing in place by camera supplied by Sponsor and add label supplied.
6.
Dressing removal assessment will be performed at this visit as it is required to remove dressing at 21 
days.
7.
Assess the peri-wound skin.
8.
Complete a full Wound Assessment (section 10.4.2).
9. 
Take photographs of wound area site. 
10.
A new dressing will be applied and the PICO 14 pump will be restarted to apply for up to    
7 days.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 81 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
11.       Take photograph of new dressing in place. 
12.
Assess subject comfort (yes, no) and pain level (Visual Analogue Scale).
13.
If any adverse device effects or device deficiencies are observed or reported, they must be recorded as 
instructed in Section 12 - Adverse events and device deficiencies. Take a photograph of the 
wound/dressing as appropriate.
14.
Instruct the subject on follow-up procedures, including returning to the treatment facility for the End of 
therapy and Exit visit 28 (-2) days. Record date of assessment.
10.1.6 END OF THERAPY AND EXIT VISIT 28 (-3) DAYS.
1.
Record date and treatment setting.
2.
Record any changes in general health and the use of concomitant medications.
3.
Record if therapy has been interrupted since the previous assessment and how long.
4.
Take photograph of dressing in place and complete the Dressing Removal Assessment.
5.
Complete a full Wound Assessment (section 10.4.2).
6.
Assess the peri-wound skin.
7.
Assess subject satisfaction (overall performance of dressing, comfort, noise level, discretene
portability, interference with daily living – showering, sleeping, socialising, working).
10.
Assess clinician and participant acceptability of PICO NPWT system (Overall satisfacti
satisfaction with ability to manage, satisfaction regarding dressing retention, satisfaction 
compared to other NPWT devices).Record date of assessment.
11.
Remove NPWT system as per procedure 9.4 for data chip collection.
12.
Record pain score (VAS) and patient comfort since last assessment and pain score on dress
removal.
13
Follow procedure for removal, appropriate labelling and storage of pump for return to 
S&N.
14.
Take photographs of the wound using camera provided by Sponsor (section 10.4.3)
If any adverse events are observed or reported, they must be recorded as 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 82 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
instructed in Section 12.
15.
Follow procedure for removal, appropriate labelling and storage of pump for return to 
S&N.
16.
Complete an Exit Form and exit the subject from the study stating the date and reason 
discontinuation. Standard care will be provided to the subject.
10.1.7 ADDITIONAL DRESSING CHANGE ASSESSMENT (DAY 1-27). 
PICO 14 dressings are intended to be used for up to 7 days. Additional dressing change assessments will be 
completed if the dressing needs changing prior to Day 28 therapy period.
1. Record date and treatment setting. 
2. Record reason for dressing change (e.g. routine, dressing saturated (exudate), 
strikethrough, leakage, pain, loss of vacuum, dressing got wet during shower/bathing,  
patient removed dressing, patient’s request, other).
3. Record the use of concomitant medications.
4. Record reason if dressing is no longer in place (e.g. pain/discomfort from the dressing, 
patient removed, patient’s request, adverse event, no vacuum, pump turned off, other).
5. Record if therapy has been interrupted since the previous assessment and how long.
6. Take photograph of dressing in place.
7. Assess subject satisfaction (overall performance of dressing, comfort, noise level, 
discreteness, portability, interference with daily living – showering, sleeping, 
socialising, working).
8. Assess ease of removal.
9. Record pain score (VAS) since last assessment and on dressing removal.
10 A suitably qualified individual to complete assessment of wound complications. If any 
complications have occurred, details of this and additional procedures to be collected.
11 Assess the peri-wound skin.
12 Photograph the wound using the camera supplied by the Sponsor.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 83 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
13 Dispense study product. Record pump lot number, size of dressing used and any 
ancillary products applied (SECURA No-Sting Skin prep, RENASYS Adhesive Gel 
Patch).
14 Assess ease of application, ease of establishing seal/negative pressure delivery, 
satisfaction of applying IP and VAS score on dressing application.
15 Take photograph of dressing in place.
16 If any adverse device effects or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 12 - Adverse events and device 
deficiencies.
17 Instruct the subject on follow-up procedures, including returning to the treatment 
facility for the next scheduled assessment 
10.1.8 CONCOMITANT MEDICATIONS AND THERAPIES.
A concomitant medication (e.g. drug, substance) and a concomitant therapy (e.g. physical therapy, TENS Unit, 
massage) are recorded at any time from enrolment into the study through the subject’s last study visit, including 
ongoing medications. 
10.1.8.1 CONCOMITANT MEDICATIONS.
10.1.8.1.1
Excluded Concomitant Medications
The following concomitant medications are not permitted from the time of entry into the study until the exit visit has 
taken place:
No other ointments/gels/topical lotions/creams should be used with the PICO system as per the IFU 
(other than the SECURA skin barrier wipes and RENASYS Adhesive Gel Patches provided as ancillary 
for the study).
10.1.8.1.2
Recording Concomitant Medications in the CRF
All medications will be recorded in the CRF. Refer to the CRF Completion Guidelines for how medications are 
recorded. 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 84 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
10.1.8.1.3
Therapies Prohibited During the Study 
The use of the following concomitant therapies is not permitted during the study period:
•
No dressings (i.e foam, gauze, ACTICOAT) should be used under the IP during therapy. Please note it is 
acceptable to use foam or gauze fillers.
•
No other NPWT devices (i.e RENASYS, Vac) should be used following the 7 day therapy treatment period 
unless it becomes necessary on clinical grounds and this would be the routine clinical protocol provided by 
the site.
10.1.8.1.4
Recording Concomitant Therapies in the CRF
Only therapies related to (directly treating) the reference incision will be recorded on the CRF. Refer to the CRF 
Completion Guidelines for how concomitant therapies are recorded.
DISCONTINUED SUBJECTS.
Discontinued subjects are those who voluntarily discontinue participation or who are lost to follow-up refer to section 
5.8 for further details. Where possible, a full Exit Visit should be completed for all subjects who discontinue the 
study early. Where consent is withdrawn, the date and any reason given for discontinuation should be captured, at 
a minimum (see Section 5.8.2).
Finally, if appropriate, the Investigator will also advise the subject of subsequent therapy and/or procedures 
necessary for their medical condition. 
Subjects who are withdrawn only from treatment will not automatically discontinue participation in the study, see 
Section 5.8.
SUBJECT PREGNANCY
Women of child-bearing potential are excluded from the study. However, if a woman becomes pregnant during the 
study, S&N must be contacted immediately once the investigator is made aware of the pregnancy and subject will 
be withdrawn from study. Pregnancy is not an adverse event; however, complications related to the pregnancy may 

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A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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be reportable as determined on a case-by-case basis. Pregnancy-related information will be collected until the end 
of the pregnancy.
STUDY METHODS AND MEASUREMENTS - CHRONIC WOUNDS AND DEHISCED SURGICAL WOUNDS 
ONLY.
10.4.1 SURGICAL DETAILS FOR DEHISCHED WOUNDS ONLY
Surgery details to be collected include the following questions:
Date of surgical procedure (DD/MMM/YYYY).
Collect surgery data [e.g. Type of surgery (type of surgery, method of closure and reference wound type and 
anatomical site).
Collect surgery risk factors (elective/emergency surgery, laparoscopic (y/n), incision length, use of 
prophylactic antibiotics, type (single / double / triple agent) and when administered (prior to start of 
surgery/after surgery began), shaving of incision (yes / no / not needed), use of an incision drape (yes / no), 
clean/contaminated surgery (clean/clean-contaminated/contaminated/dirty), intraoperative warming (yes / 
no)).
10.4.2 WOUND ASSESSMENT.
Reference Wound Details Recorded at Initial Assessment
Location of wound:
o
Upper leg;
o
lower leg;
o
knee;
o
ankle;
Duration of wound (weeks/months/years)
Previous Treatment (add options given in CRF)

Study Protocol—Device
A prospective, study to evaluate the safety 
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management of acute and chronic wounds
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Has the reference wound been debrided? (Yes/No), if yes how?
Has the reference wound been cleansed? (Yes/No. If yes, give detail of cleanser used).
Reference wound measurement taken using the longest length, and width at right angles at  midway 
point of length:
o
Length (cm); 
o
Width (cm);
o
Depth (mm)
Appearance of the reference wound using a Modified Bates-Jensen Wound Assessment Tool: 
o
Necrotic Tissue Type: Pick the type of necrotic tissue that is predominant in the wound according to 
colour, consistency, and adherence using this guide:
White/grey non-viable 
tissue
=
May appear prior to wound opening; skin surface is 
white or grey.
Non-adherent, yellow 
slough
=
Thin, mucinous substance; scattered throughout 
wound bed; easily separated from wound tissue.
Loosely adherent, yellow 
slough
=
Thick, stringy, clumps of debris; attached to wound 
tissue.
Adherent, soft, black 
eschar
=
Soggy tissue; strongly attached to tissue in centre or 
base of wound.
Firmly adherent, 
hard/black eschar
=
Firm, crusty tissue; strongly attached to wound base 
and edges (like a hard scab).
None visible
< 25% of wound bed covered
25% to 50% of wound covered
50% and < 75% of wound covered
75% to 100% of wound covered

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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o
Granulation Tissue: Granulation tissue is the growth of small blood vessels and connective tissue to 
fill in full thickness wounds. Tissue is healthy when bright, beefy red, shiny and granular with a velvety 
appearance. Poor vascular supply appears as pale pink or blanched to dull, dusky red colour.
Skin intact or partial thickness wound
Bright, beefy red; 75% to 100% of wound filled &/or tissue overgrowth
Bright, beefy red; < 75% & > 25% of wound filled
Pink, &/or dull, dusky red &/or fills < 25% of wound
No granulation tissue present
o
Epithelialization: Epithelialization is the process of epidermal resurfacing and appears as pink or red 
skin. In partial thickness wounds, it can occur throughout the wound bed as well as from the wound 
edges. In full thickness wounds, it occurs from the edges only. Use a transparent metric measuring 
guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine the percent
of wound involved and to measure the distance the epithelial tissue extends into the wound.
100% wound covered, surface intact
75% to < 100% wound covered &/or epithelial tissue extends to > 0.5 cm into wound bed
50% to < 75% wound covered &/or epithelial tissue extends to < 0.5 cm into wound bed
25% to < 50% wound covered
< 25% wound covered
Level of Exudate
o
None;
o
Light;
o
Moderate;
o
Heavy
Level of Pain since the last assessment (0-9; 0= no pain, 9 = maximum pain)
Clinical judgement reference wound is clinically infected (Yes/No)

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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Signs of clinical infection
o
None;
o
Wound static or deteriorating;
o
Increased exudate-secretion levels;
o
Increased pain;
o
Increased temperature around wound;
o
Discolouration of granulation tissue;
o
Friable granulation;
o
Tissue necrosis;
o
Local erythema;
o
Oedema;
o
Purulent drainage;
o
Odour;
o
Other
10.4.3 ASSESSMENT OF PERI-WOUND SKIN.
The surrounding skin will also be assessed by the above mentioned clinician. The clinician will assess whether the 
skin appears healthy or is fragile, inflamed, eczematous, dry/flaky, macerated or has erythema.
Condition of peri-wound?
o
Normal
o
Erythematous
o
Oedematous
o
Eczematous
o
Excoriated
o
Macerated
o
Indurated
o

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
10.4.4 CHRONIC WOUND SITE AND DRESSING PHOTOGRAPHS.
An image of the subject’s will be captured prior to initial dressing application, at 7 days, 14 days, 21 days (or when 
dressing is removed) and at end of therapy at 28 days  (or early exit visit) using a digital camera supplied by S&N. 
The images will be used as a pictorial record of the study reference wound. 
A photo ruler labelled with the subject’s number, study number and the date will be supplied by S&N and will be 
placed in the field of the photograph. The image should be framed such that the entire wound/dressing nearly fills 
the frame. Ensure that identifying information, such as the subject’s face, are not visible in the photograph. After 
obtaining the image, ensure that the image is clear (in focus) and that there is sufficient light to clearly see the 
wound/dressing. Instructions for capturing images will be supplied with the cameras. Training on the use of the 
camera will be given during the site initiation visit.
An image of the dressing in place will be taken after application, and before removal, to check the device 
compliance.
If an AE or any other change to the subject’s surgical site occurs during the study, further images of the wound will 
be captured to document the event if there is visible impact of the AE or other change. A photograph should also 
be taken where appropriate of all DevD reported.
All photographs should be uploaded to the relevant assessment on the CRF.
10.4.5 DRESSING APPLICATION ASSESSMENT.
Dressing Application information to be collected include the following questions. 
To be completed for the reference wound (Day 0 – Treatment Discontinuation): 
Any products applied at dressing application (None/ SECURA No-Sting Barrier Film wipes / RENASYS 
Adhesive Gel Patch / topical antibiotics / other). Reduce bioburden, Lower risk of infection, Other.
o
Renasys gel patch used (Yes/No)
-
If used how long did the patch last for, and any problems upon removal. 
-
Did the Renasys gel patch provide comfort to the subject’s reference wound?

Study Protocol—Device
A prospective, study to evaluate the safety 
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management of acute and chronic wounds
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PICO 14 Pump UDI Number
PICO 14 pump Lot Number and Catalogue number will also be collected. 
If Dressing used is separate to what is provided in the PICO14 kit please record UDI, Lot and Catalogue 
number of the dressing.
Size of PICO 14 NPWT dressing kit size used (10 x 20 cm / 10 x 30 cm / 10 x 40 cm / 15 x 15 cm / 15 x 20 
cm / 15 x 30 cm / 20 x 20 cm / 25 x 25 cm / Small Multisite / Large Multisite).
-
Was the dressing used on the chronic wound conformable (Yes/No)
If No, please comment.
Easy to create a vacuum on the PICO dressing (Yes / No).
Easy to operate the pump on the PICO dressing (Yes / No).
Dressing application on chronic wound:
o
Dressing easy to apply (Yes / No).
o
Satisfaction with the application of the PICO dressing (Yes / No).
o
Dressing comfortable (Yes / No).
Question asked at all assessments from Treatment Discontinuation to Day 28 on wound
List the dressings that has been applied to the at this assessment (None / Steri-Strips / Foam dressing / 
Films/polymer dressing / Alginate/ Hydrofiber / Antimicrobial dressings (silver/iodine) / Hydrocolloid / Non-
adherent dressing / Odour absorbent dressing / Absorbent pads / Bandages / Hydrogels / Gauze / Other).
10.4.6 DRESSING REMOVAL ASSESSMENT (AT DAY 14 AND DAY 28, ALSO APPLICABLE IF 
DRESSING HAS TO BE CHANGED BEFORE DAY 14/ DAY 28).
Dressing removal information to be collected include the following questions: 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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The dressing check indicator flashes routinely every 24 hours as a reminder to check the dressings. (Checked at 
day 1, 2, 3, 4, 5, 6 and 7 etc.) and (Checked by HCP/Patient).
To be completed for the chronic wound:
Subject treatment setting (In-patient / Out-patient / Other).
Dressing comfortable during wear (Yes / No. If no, please comment).
Dressing acceptable to the patient (Yes / No. If no, please explain).
Acceptable dressing exudate management (Yes / No. If no, please comment).
Level of pain from the wound since the last assessment (0-10 scale).
Reason for dressing change (Routine/ inadequate exudate management / pain-discomfort from the dressing 
/ dressing damaged / dressing fell off / patient removed dressing / adverse event / surgical procedure / safety 
alarm / dressing components not in place / no vacuum /other).
Is the dressing still covering the wound as applied? (Yes / No).
How long has the dressing not covered the wound? (Day / Hour / Min) if applicable.
Has the dressing been removed at any point since application? (Yes / No).
How long was the dressing not in place? (Day / Hour / Min).
Has there been any period that the vacuum was not applied during therapy apart from showering? (Yes / 
No. If yes, for how long).
Level of Pain on removal of dressing (0 -10 scale).
Was the dressing easy to remove? (Yes / No. If no, please comment).
10.4.7 TREATMENT DISCONTINUATION.
Treatment discontinuation information to be collected include the following questions,
Date of treatment discontinuation.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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Reason for treatment discontinuation (End of treatment period (28 days) / Vacuum interrupted for > 48 
hours / A change in treatment is clinically warranted / Subject withdrawn—Adverse Event / Other 
(specify). If Incision management complete. 
Overall subject assessment of PICO 14.
o
How was the pump carried around (Pump Clip / Pocket / Hand / Other? If other, please state). 
If the Pump Clip used, Was the clip a useful feature (Yes / No. If No, why).
o
Subject satisfaction with the following aspects of the NPWT system: Overall performance, 
Comfort during wear, Noise Level, Discreetness, Portability (Scale).
o
Interference with daily living – Showering, Sleeping, Socialising, Working (Yes, please 
comment/ No).
Overall investigator assessment of PICO 14.
o
Overall is the Investigator satisfied with the performance of the PICO 14 system (pump and 
dressing) (Yes / No. If No please comment).
o
Following questions will be asked :"Are you satisfied with the PICO 14 systems ability to 
manage wound/ incision?", Are you satisfied with the PICO 14 systems ability regarding 
dressing retention?" and "Are you satisfied with the PICO 14 systems ability when compared to 
other NPWT devices?"
10.4.8 SUBJECT EXIT.
Subject exit information to be collected include the following questions,
Date of Subject Exit.
Reason for Subject Exit (end of therapy at day 28 /  Subject Withdrawn – Non-compliance / Subject 
Withdrawn – Adverse Event / Subject Withdrawn – Subject’s own request / Subject Withdrawn – Lost 
to follow-up / Investigator Decision / Other (Specify)).
Complete exit questionnaire. 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
PICO 14 DEVICE RETURN.
All PICO 14 pumps will be returned to S&N for download of the in-built data chip. Once the pumps have been 
removed from the subject they are to be decontaminated using the following procedure:
Label a zip-locked bag with subject ID number, initials and date labelled.
At the Treatment Discontinuation Assessment the PICO dressing will be removed from the subject in order 
to inspect the surgical site as per the study protocol.
The PICO dressing will be disconnected from the pump and the dressing disposed of as clinical waste.
The surface of the pump should be wiped with a disinfectant wipe. Remove and retain the batteries. Clean 
the batteries and the inside of the battery compartment with a disinfectant wipe.
Put the PICO pump and the batteries in the labelled bag.
During the monitoring visits, the study monitor will count the devices and verify that they have been labelled 
correctly, collect devices and shipment will be arranged to Smith+Nephew Wound Management, Hull, UK.
In an identified handling area at Smith+Nephew Wound Management, Hull, UK, the devices shall be processed to 
have their internal memory contents downloaded, analysed and saved following an approved NPD (New Product 
Development) Work Instruction.
HEALTH ECONOMICS/QUALITY OF LIFE.
No Quality of Life Questionnaires will be collected for this study however, assessment of acceptability of the therapy 
will be made by specific targeted questions to the clinician and subject as described in section 11.4.5 above.
STATISTICAL DESIGN.
A Statistical Analysis Plan (SAP) will be written and finalized prior to database lock. The following is a brief 
description of the analyses to be described in this plan. The SAP will be more detailed and account for all analyses.  
All analyses will be conducted with statistical software SAS Version 9.4 or later. 

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management of acute and chronic wounds
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
GENERAL.
Smith+Nephew’s Global Biostatistics group will conduct the statistical analysis for this study. The subject data will 
be described and summarised using the baseline demographic and medical variables which include but are not 
limited to age, gender, ethnicity, medical and medication history, diagnostic factors as well as study process 
variables (e.g. AE and withdrawal(s)). Summary statistics will be given according to the nature of the variable, 
continuous or categorical. For continuous variables, the number of observations, mean, standard deviation, median, 
minimum, and maximum will be presented, while for categorical variables the number of observations, frequency, 
and percentages will be reported. Summary statistics will be presented by wound type and by country, where 
appropriate.
Primary, secondary, and exploratory outcome variables and derived variables will also be summarised accordingly. 
Parametric statistical tests will be used if the data is normally distributed and corresponding non-parametric tests 
will be considered if the data is not. Where necessary, suitable regression techniques will be used to adjust for 
confounding since the study is non-randomised. Unless otherwise stated, the results will be reported at 5% 
significance level and where appropriate 95% confidence intervals will be given.
ANALYSIS POPULATIONS.
Full analysis set population (FAS), including all subjects who were recruited into the study and have at 
least one post-baseline visit. 
Safety Population (SAF), including all subjects who have received the study device.
Per-Protocol Population (PP), including all subjects in the full analysis set who have no significant protocol 
deviations and met the inclusion/exclusion criteria.
Statistical analysis will be performed using each of the patient populations as follows: Analysis of the primary, 
secondary and exploratory efficacy objectives will be performed separately using both the Full Analysis Set and the 
Per Protocol Population. All safety analyses will utilize the Safety Population.

Study Protocol—Device
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management of acute and chronic wounds
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
BASELINE DATA.
For chronic wounds and dehisced surgical wounds Day 0 (baseline) will be classified as the screening/ baseline 
visit. For closed surgical incisions Day 0 (baseline) will be classified as the operative day.
The subjects will be described and summarised using the baseline demographic and medical variables which 
include but are not limited to age, gender, ethnicity, medical and medication history, diagnostic factors. Summary 
statistics will be given according to the nature of the variable; continuous or categorical.  
EFFICACY ANALYSIS.
The study will assess and evaluate the efficacy of PICO 14 by establishing equivalence in the mean operating 
negative pressure over a period of 14 days with a pressure of -80.2 mmHg. The clinical efficacy of PICO 14 will be 
concluded if statistically significant equivalence (within an equivalence margin of ±6mmHg) is achieved. Secondary 
and exploratory outcomes will be evaluated to consolidate the primary outcome analysis. 
The study is non-comparative and non-randomised, the impact of confounding on the measures of efficacy may be 
expected and will be evaluated through fitting appropriate models and adjusting for potential factors. 
ANALYSIS OF PRIMARY ENDPOINT.
Delivery of -80mmHg negative pressure to the wound bed over the treatment period. This will be 
measured by download of the built-in data chip from the PICO 14 devices to collect NPWT delivery 
status.
The following hypotheses will be tested to establish equivalence of the PICO 14  integrated pump system 
compared to the literature value, with equivalence margin, 1>0: 
H0
-
0 
1
Ha
-
0 | < 1
In the stated hypotheses, 
represents the assumed mean operating pressure taken from data extracted 
from a PICO sample device (-80.2 mmHg) and  
represents the mean PICO 14 pump operating pressure.  

Study Protocol—Device
A prospective, study to evaluate the safety 
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The equivalence limit 
1 = 6mmHg was chosen as a conservative non-clinically significant difference 
assuming that the difference is actually 0. 
The average negative pressure across all subjects will be summarised as a continuous variable.
The difference between the average negative pressure from baseline to treatment discontinuation and the 
assumed mean negative pressure (-80.2mmHg) will be calculated for each subject separately. This 
difference for closed incisions, dehisced surgical wounds and chronic wounds combined will be assessed 
using a two one-sided t-test at the alpha level of 0.025. The mean difference will be presented along with 
the associated 95% confidence interval and if the 95% confidence interval lies fully within the equivalence 
boundaries (-6; 6) then the null hypothesis is rejected and clinical equivalence will be confirmed.
As an additional analysis the above will be repeated separately for each wound indication.
No occurrence of exudate leaks observed during the dressing wearing period resulting or not, in an 
unplanned dressing change.
Occurrence of exudate leaks in the opinion of the clinician will be recorded in the CRF. For non-occurrence 
of exudate leaks, a binary variable indicating presence of/absence of will be defined. For the combined 
group (closed surgical incisions, dehisced surgical wounds and chronic wounds) the frequency together with 
percentage of reported/identified outcome will be reported with a 95% CI. This will also be summarised 
separately for each wound indication.
Logistic models will be fitted and important associated factors adjusted for if there is adequate data.
Composite Clinical Success (CCS) defined as a binary variable (1/0) (1 if both of the following are true and 0 
if either one is false):
A. Nominal pressure is in the interval 80mmHg ± 6mmHg.
B. No exudate leakage.
The CCS will be reported as a count and percentage with a 95% CI for the combined group and separately for 
each wound indication.

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ANALYSIS OF SECONDARY ENDPOINTS.
Closed Incision Only:
Clinical performance and safety of the PICO 14 NPWT system over a 14 day therapy and 30 day follow-up period 
to include:
Scar quality measured by POSAS score at Day 14, and day 30.
Incidence of Surgical Site Infection (SSI) and incidence of Surgical Site Complication (SSC) within 30 days 
of surgery [CDC criteria].
Condition of peri-wound skin assessed through visual inspection at 7, 14 and 30 days.
Level of pain on application, during wear and at dressing removal assessed by VAS scale over the 14 day 
treatment period.
Patient satisfaction during wear assessed over the 14 day period. This includes leakage, feeling of moisture 
on the skin, odour control, level of protection, comfort and showerproof qualities.
Ease of application and removal of the PICO 14 dressing.
Dressing wear time.
Dressing conformability
Dressing change frequency and reason for dressing change.
Clinician acceptability of PICO 14 system at discontinuation of therapy.
Patient acceptability of PICO 14 system at discontinuation of therapy.
The POSAS consists of two parts: a Patient Scale and an Observer Scale. Each of the six items on both scales has 
a 10-point score. The lowest score is 1 and corresponds to the situation of normal skin (normal pigmentation, no 
itching etc.) and goes up to 10 indicating the worst imaginable. Total scores for both scales will be calculated 
separately by summing up the scores of each of the six items. An ‘Overall Opinion’ is scored separately of both 
patients and observers. Total scores and overall opinions will be summarised. 
For incidence of SSC and incidence of SSI, binary variables indicating presence of/absence of will be defined. 
Total frequencies and number of subjects reporting each will be reported together with percentages. 

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Condition of the peri-wound (e.g., healthy, fragile, inflamed, erythema, bruising, eczematous, dry/flaky, macerated) 
will be summarised.
Level of pain on dressing application will be collected at Day 0 and for each dressing change assessment, level of 
pain during wear will be collected throughout the 14 day period, and level of pain on dressing removal will be 
collected at routine dressing changes and at the end of study visit. These will be measured using a VAS scale and 
will be summarised by wound type.   
Patient satisfaction will be measured by overall performance of the dressing, comfort, noise level, discreteness, 
portability and interference with daily living – showering, sleeping, socializing and working. Summary statistics will 
be given according to the nature of the variable, continuous or categorical. 
Ease of application, ease of establishing seal/negative pressure delivery, satisfaction of applying IP, knowing when
to perform a dressing change and ease of removal will be reported by the clinician and frequencies will be 
summarised. 
Dressing wear time (days) will be summarised as wear time per subject, by wound type and overall.  Dressing 
change frequency will be summarised as the number of dressings per subject. Dressing conformability will be 
summarised as a categorical endpoint
Clinician and patient acceptability of PICO 14 system at discontinuation of therapy will be summarised through 
descriptive statistics and tabulated accordingly.
Chronic wounds and dehisced surgical wounds only:
Clinical performance and safety of the PICO 14 NPWT system over a 28 day therapy and no follow-up period to 
include:
Incidence of clinical infection.
Appearance of the wound in terms of tissue type and amount, exudate type and amount, skin condition 
surrounding the wound, peripheral tissue edema and induration.
Condition of peri-wound skin assessed through visual inspection at 7, 14, 21 and 28 days.

Study Protocol—Device
A prospective, study to evaluate the safety 
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Percentage reduction in area, depth and volume from baseline to day 7, day 14, day 21 and day 28.
Level of pain on application, during wear and at dressing removal assessed by VAS scale over the 28 day 
treatment period.
Patient satisfaction during wear assessed over the 28 day period. This includes leakage, feeling of moisture 
on the skin, odour control, level of protection, comfort and showerproof qualities.
Ease of application and removal of the PICO 14 dressing.
Dressing wear time.
Dressing conformability
Dressing change frequency and reason for dressing change.
Clinician acceptability of PICO 14 system at discontinuation of therapy.
Patient acceptability of PICO 14 system at discontinuation of therapy.
Incidence of clinical infection will be summarised at all study visits and dressing changes by wound type and overall.
Appearance of the wound will be assessed by size, depth, edges, undermining, necrotic tissue type and amount, 
exudate type and amount, skin colour surrounding the wound, peripheral tissue edema and induration, granulation 
tissue and epithelialization. Numbers and percentages will be presented by wound type for baseline and Day 28.
Condition of the peri-wound (e.g., healthy, fragile, inflamed, erythema, bruising, eczematous, dry/flaky, macerated) 
will be summarised.
The reference wound length, width and depth will be used to derive area and volume which will be summarised at 
each study visit. Percentage reduction in area and volume will be calculated and summarised using a Wilcoxon 
Signed Rank test from baseline to all post-baseline study visits.
Level of pain on dressing application will be collected at Day 0 and for each dressing change assessment, level of 
pain during wear will be collected throughout the 28 day period, and level of pain on dressing removal will be 
collected at routine dressing changes and at the end of study visit. These will be measured using a VAS scale and 
will be summarised by wound type.   

Study Protocol—Device
A prospective, study to evaluate the safety 
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management of acute and chronic wounds
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Patient satisfaction will be measured by overall performance of the dressing, comfort, noise level, discreteness, 
portability and interference with daily living – showering, sleeping, socializing and working. Summary statistics will 
be given according to the nature of the variable, continuous or categorical. 
Ease of application, ease of establishing seal/negative pressure delivery, satisfaction of applying IP, knowing when 
to perform a dressing change and ease of removal will be reported by the clinician and frequencies will be 
summarised. 
Dressing wear time (days) will be summarised as wear time per subject, by wound type and overall.  Dressing 
change frequency will be summarised as the number of dressings per subject. Dressing conformability will be 
summarised as a categorical endpoint
Clinician and patient acceptability of PICO 14 system at discontinuation of therapy will be summarised through 
descriptive statistics and tabulated accordingly.
ANALYSIS OF OTHER ENDPOINT(S).
There are no other endpoints planned for this study.
SAFETY ANALYSES.
Adverse Events and Device Deficiencies.
All safety analyses and summaries will be conducted using the Safety Population. Unless otherwise stated.
Extent of Exposure
The duration of treatment will be summarised by wound type and overall.
Adverse Events
The number of subjects reporting: adverse events, serious adverse events, adverse device effects, serious adverse 
device effects and unanticipated serious adverse device effects will be summarized. In addition, for each adverse 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
event, the following will be summarized: severity, the relationship to the investigational device, outcome and duration 
of the resolved adverse events and the duration of the adverse events at trial discontinuation.
Device deficiencies
The number of device deficiencies and the number of patients reporting a device deficiency will be summarised.
The number of device defficiencies leading to a serious adverse device effect will also be summarised and they 
will be listed along with any corrective actions taken (if any).
INTERIM ANALYSES.
There is no interim analysis planned for this study.
SAMPLE SIZE JUSTIFICATION.
Data extracted from a PICO sample device showed that the mean operating pressure was -80.2 mmHg (SD=14.8). 
It is assumed that all the PICO 14 pumps will have a similar mean operating pressure.   The following hypotheses 
will be tested to establish the clinical equivalence in mean operating pressure of PICO 14  integrated pump systems 
over a period of 14 days compared to the sample PICO pump mean pressure (-80.2mmHg) with equivalence 
margin, 1>0: 
H0
-
0 
1
Ha
-
0 | < 1
-
80.2mmHg, SD=14.8) and  
represents the mean operating pressure of the study PICO 14 integrated pump 
systems.  The equivalence 
1 = 6mmHg was chosen as a conservative non-clinically significant difference for 
operating pressure assuming the difference is actually 0. The hypothesis will be tested by two one-sided t-test at 
the alpha level of 0.025.  If the null hypothesis is rejected, clinical equivalence will be confirmed.
Based on data and assumptions used for sample size estimation (mean=-80.2mmHg, SD=14.8), a minimum of 55 

Study Protocol—Device
A prospective, study to evaluate the safety 
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
6mmHg using a two one-sided t-test (TOST) approach. Drawing from past experience, it is expected that 
approximately 20% of the subjects may be lost to follow up by the end of the study and therefore to account for this 
N=70 subjects will be recruited into this study. This will allow for a minimum of 10 subjects with each of the following 
indications to be recruited: Chronic open wounds (pressure ulcers, venous leg ulcers and diabetes-related foot 
ulcers), dehisced surgical wounds and closed surgical incisions (post-operative incisions following hip or knee 
arthroplasty). 
The sample size was estimated using SAS V9.4.
ADVERSE EVENTS AND DEVICE DEFICIENCIES.
DEFINITIONS.
The categories of adverse events are shown in table 12.1-1. The definitions for each of these categories are given 
in the subsequent sections.Table
12.1-1: Categories of Adverse Event
NOT DEVICE-RELATED
DEVICE- OR PROCEDURE- RELATED
Non-Serious 
Adverse Event (AE)
Adverse Device Effect (ADE)
Serious
Serious Adverse Event 
(SAE)
Serious Adverse Device Effect
(SADE) (See 12.1.3)
Anticipated
Unanticipated
Anticipated Serious Adverse 
Device Effect (ASADE)
Unanticipated Serious Adverse 
Device Effect (USADE)

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A prospective, study to evaluate the safety 
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
12.1.1 Adverse Event
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device and whether anticipated or unanticipated.  
Note 1: This definition includes events related to the investigational medical device or the comparator. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to the use of investigational medical 
devices.
AE is used both to refer to AE which do not meet the definitions of Adverse Device Effects or Serious Adverse 
Events and as an umbrella term referring to adverse events of all classifications. 
An AE can be any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom, or 
disease. For reporting purposes, emphasis is placed first and foremost on whether or not the event constitutes an 
untoward medical occurrence.
12.1.2 ADVERSE DEVICE EFFECT.
An Adverse Device Effect (ADE) is an adverse event related to the use of an investigational medical device. 
Note 1: This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation or operation, or any malfunction of the investigational medical device. 
Note 2: This definition includes any event resulting from use error or from intentional misuse of the investigational 
medical device. 
Note 3: This includes "comparator" if the comparator is a medical device.

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Not Related - An AE is considered to be not related to the use of an IP or the procedure when the effect is 
DEFINITELY UNRELATED to have any relationship to the use of the IP or the procedure;
Related – An AE is considered to be related to the use of an IP or the procedure when there is a POSSIBLE, or 
DEFINITE relationship between the AE and the use of the IP or the procedure.
An ADE is further categorized depending on whether the criteria in section 12.1.3 and 12.1.4 are met.
12.1.3 RELATED SERIOUS ADVERSE EVENTS AND SERIOUS ADVERSE DEVICE EFFECTS
An AE or ADE is considered a Serious Adverse Event (SAE) or Serious Adverse Device Effects (SADE) if, it led to 
any of the following:
a)
death,
b)
serious deterioration in the health of the subject, users or other persons as defined by one or more of the 
following: 
1)
a life-threatening illness or injury, or
2)
a permanent impairment of a body structure or a body function including chronic diseases, or
3)
in-patient or prolonged hospitalization, or
4)
medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a 
body structure or a body function,
c)
foetal distress, foetal death or a congenital abnormality or birth defect including physical or mental 
impairment
Note 1: Planned hospitalization for a pre-existing condition, or a procedure required by the study protocol, without 
serious deterioration in health, is not considered a serious adverse event.
12.1.4 ANTICIPATED/UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT.
An Unanticipated Serious Adverse Device Effect (USADE) is a serious ADE which by its nature, incidence, severity 
or outcome has not been identified in the current version of the risk assessment. 

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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Note 1: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or 
outcome has been identified in the risk assessment. 
12.1.5 SEVERITY.
The severity of every AE will be assessed by the PI or medically qualified site staff to whom the responsibility has 
been delegated and documented on the delegation of authority log. AE should be classified as mild, moderate, or 
severe, regardless of whether or not the AE are considered to be serious or non-serious. The classification should 
be based on the following definitions:
Mild -
An event is mild if the subject is aware of, but can easily tolerate the sign or symptom;
Moderate - An event is moderate if the sign or symptom results in discomfort significant enough to cause 
interference with the subject’s usual activities;
Severe - An event is severe if the sign or symptom is incapacitating and results in the subject’s inability to work or 
engage in their usual activities.
12.1.6 DEVICE DEFICIENCY.
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety 
or performance. DD includes malfunctions, use errors and inadequate labeling. 
Note 1: DD includes malfunctions, use errors and inadequacy in the information supplied by the manufacturer including 
labelling. 
Note 2: This definition includes device deficiencies related to the investigational medical device or the comparator.
Device deficiencies that did not lead to an adverse event but could have led to a medical occurrence 
a) if either suitable action had not been taken, 
b) if intervention had not been made, or 
c) if circumstances had been less fortunate, 
are considered Device Deficiencies with potential to cause SADE and shall be reported as specified in section 12.3.

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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
AE CODING DICTIONARY.
Coding for this study will be done per International Medical Device Regulators Forum (IMDRF) AE Terminology 
Annex E – Clinical signs, symptoms and conditions.
REPORTING PROCEDURES.
AE of any kind and DD will be recorded in the applicable CRF and source notes to include the date of occurrence, treatment 
and the details resolution. The Investigator will evaluate all AE for relationship to the device and procedure, seriousness, and 
severity (if applicable). DD will be evaluated for potential to cause SADE.  The following timescales should be followed for the 
AE/DD information to be submitted/entered into the CRF and reported to the Sponsor or designee (see figure 12.2-1):
ADE and DD – without unreasonable delay
SAE, SADE and DD with potential to cause SADE – immediately (i.e. within 24 hours of the investigator 
being informed about the event)
All other events – according to usual timescales
In addition to inputting SAE and SADE information within 24 hours of being aware of the event, the investigator should email 
Clinical.safety@Smith-nephew.com to alert the safety representative of the events existence and to clarify details if 
necessary.
For ADE and DD, date of occurrence, and details of the product/procedure related to the event will be included and where 
applicable, pictures taken of the device. The deficient product should be retained for return to S+N unless it is contaminated 
(e.g., used dressings must not be retained). Updates to submitted information will be recorded in the CRF according to the 
timescales above.
All adverse events will be reviewed by a medically qualified person appointed by the Sponsor to determine which, if any, 
meet criteria for expedited reporting to the regulatory authorities. 
The investigator will inform the regulatory agency and IRB/IEC of adverse events as per the requirements listed below: -
Give timelines for applicable IRB/reg authority here.
If there is no clear timescale given by applicable IRB/reg authority then the following text should be used, otherwise delete:
Unanticipated SADE’s and DD’s that could have led to SADE will be reported to IEC/IRB and regulatory authorities within 10 
working days.
All other events will be reported on a periodic/annual basis.
Depending on the nature of the adverse event, S+N may request copies of the subject’s medical records, Imaging, Operative 
notes, as well as results of any relevant laboratory tests performed or other documentation related to the AE. If the subject

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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
was hospitalized, a copy of the discharge summary may be requested by S+N and should be forwarded as soon as it 
becomes available. In certain cases, S+N also may request a letter from the Investigator that summarizes the events related 
to the case. Refer to the ISF Sponsor Contact Information Sheet to report SAE, unanticipated SADE, anticipated SADE, and 
DD.
Figure 12.3-12-1: Evaluation and Reporting of AE
Site 
aware 
of AE
Investigator 
assesses 
seriousness 
Serious
Investigator 
assesses device 
relationship
Related 
Investigator 
assesses whether 
SADE is 
anticipated
Not Related
Serious Adverse 
Event (SAE)
Unanticipated
Unanticpated 
Serious Adverse 
Device Effect 
(USADE)
Anticipated
Anticipated 
Serious Adverse 
Device Effect 
(ASADE)
Investigator 
assesses device 
relationship
Non-serious
Related
Adverse Device 
Effect (ADE)
Not Related
Adverse Event 
(AE)
Complete CRF 
and alert S+N 
IMMEDIATELY  
Record 
information in 
patient CRF 
according to 
usual 
timescales.
Complete CRF 
and alert S+N 
without 
unreasonable 
delay. 
Record 
details in 
subject’s 
medical 
records

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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
EVALUATION AND REPORTING OF DD
Figure 13-1: EVALUATION AND REPORTING OF DD
Site aware 
of DD
Investigator 
assesses whether 
could have led to 
SADE 
Potential to cause SADE
No potential to cause SADE
Complete CRF and alert S+N 
Without Unreasonable Delay
Record information in patient 
CRF according to usual 
timescales.
Record details in subject’s 
medical records
UNBLINDING OF INVESTIGATIONAL PRODUCT.
This is not applicable as the study is not blinded.
FOLLOW-UP OF SUBJECTS WITH ADVERSE EVENTS.
For subjects who are experiencing ongoing unresolved AE at the time of their study completion or early 
discontinuation from the study, it is recommended that the Investigator schedule an appropriate follow-up visit to 
determine the outcome of the event. 
Any additional data must be documented and available to the Sponsor who will determine whether the data need 
to be documented in the CRF/Clinical Study Report.

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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
13.2.1 Ongoing Adverse Events at Study Discontinuation.
Adverse events which are related to a study procedure or S+N IP and are ongoing at the end of subject’s 
participation: The event should be followed until it is either resolved or until the event has become chronic and is 
not expected to further improve based on Investigator’s review of the event.
Adverse events which are not related to a study procedure or S+N IP and are ongoing at the end of subject’s 
participation should be followed for 30 days after discontinuation or if the AE is resolved, whichever is sooner.
At the time of data analysis (e.g., interim or final), an evaluation of ongoing events should take place and be listed 
as ongoing in the safety table.
INVESTIGATOR OBLIGATIONS.
The Principal Investigator will comply with the commitments outlined in the in the Statement of 
Investigator, provided by the Sponsor/within the Clinical Trial Agreement>, and with Good Clinical 
Practice (GCP), and all applicable regulatory requirements as outlined in Appendix 23.7 of this 
protocol.
In addition, the PI will ensure that the Financial Disclosure Statements will be completed by the PI 
and the Sub-Investigator upon entry into the study and as any changes that affect their financial 
disclosure status occur during the course of the study and up to one year after study completion.
SPONSOR AND MONITOR RESPONSIBILITIES.
The Sponsor will designate a monitor to conduct the appropriate site visits at the appropriate intervals. The clinical 
investigation will be monitored to ensure that: the rights and wellbeing of the subjects are protected; the reported 
data are accurate, complete, and verifiable from the source documents; and the study is conducted in compliance 
with the currently approved protocol and amendment(s), if applicable, with GCP regulations, and with applicable 
regulatory requirements.
Detailed monitoring requirements will be documented in the Clinical Monitoring Plan for this study.

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SITE QUALIFICATION VISIT.
A site qualification visit may be performed by the Sponsor prior to the execution of a clinical agreement to ensure 
that all Investigators have the appropriate training, staff, facilities, and resources to adequately conduct the study.
SITE INITIATION VISIT.
A site initiation visit to provide training on the specifics of the study, site obligations and expectations of study 
conduct will be performed by the Sponsor or qualified person designated by the Sponsor following the execution of 
the CTA and documented IRB/IEC approval. 
INTERIM MONITORING VISIT
Regular interim monitoring visits will be performed by the Sponsor or qualified person designated 
by the Sponsor.
SPONSOR AUDITS AND REGULATORY INSPECTION.
Quality Assurance auditors, whether an employee of the Sponsor or its designee, may evaluate study conduct at 
the study sites. These parties must have access to any and all study reports and source documentation, regardless 
of location and format. 
CLOSE-OUT VISIT.
A study close-out visit will be performed by the Sponsor or designee to retrieve and account for all remaining clinical 
data and to resolve outstanding queries. During study close-out, the monitor will review investigator files to ensure 
required documents and records are on file, confirm the disposition of any other ancillary items used for the study, 
and review regulatory requirements regarding records retention and IRB/IEC reporting requirements. When no 
subjects have been included, a remote close-out visit may be conducted. 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 111 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
PROTOCOL AMENDMENTS.
Amendments should be made only in necessary cases once the study has started. Protocol amendments must be 
approved by the protocol signatories prior to submission to the IRB/IEC. Protocol amendments need to be approved 
by the IRB/IEC and Regulatory Authority(ies), according to the applicable requirements prior to implementation at 
the site.
CONFIDENTIALITY OF THE STUDY.
The confidentiality of this study and associated documents is governed by the terms of the Clinical Trial Agreement
(CTA).
STATEMENTS OF COMPLIANCE.
This clinical study will be performed in compliance with the ethical principles of the Declaration of Helsinki; and ISO 
14155: Clinical investigation of medical devices – Good Clinical Practice.
This clinical study will not commence until the required approval/favorable opinion from the IRB/IEC or regulatory 
authority has been obtained. Any additional requirements imposed by the IRB/IEC or regulatory authority will be 
followed. 
Public/Products Liability Insurance has been purchased by Smith+Nephew plc. Worldwide and incorporates 
coverage for personal injury in respect of clinical studies. The Sponsor agrees to operate in good faith and in 
accordance with ABHI (Association of British Healthcare Industries) guidelines regarding compensation for injury 
arising in the course of clinical studies.
END OF STUDY.
The end of the study is defined as the last visit of the last subject undergoing treatment in the study. The expected 
duration of the study as defined from the first site initiated to the last subjects last visit is approximately 6 months. 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 112 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Should any of the subjects suffer a complication during the course of the study, they will be analysed on an intention 
to treat basis and will be treated according to standard clinical care (that is considered to be the best care for the 
applicable coplication).
Early suspension or termination should only occur due to a safety issue since there is no interim analysis for this 
study and a full data set is required for BSI requirements and comparison of data to the pre-registration study.
Should circumstances arise which require the termination of the entire study prior to its planned completion (e.g.,
safety concerns) or circumstances arise which mean the end of the participation of an individual site (e.g., departure 
of Investigator, non-compliance), then this will be undertaken according to the SOPs of the Sponsor. 
PUBLICATION POLICY 
PUBLICATION OF STUDY DATA
The preparation and submission for publication of manuscripts containing the study results shall be in accordance 
with a process determined by the Clinical Trial Agreements between the study Sponsor and participating institutions. 
The publication or presentation of any study results shall comply with all applicable privacy laws.
DATA SHARING
Smith+Nephew is committed to upholding the highest ethical and legal standards involved in conducting clinical 
trials. Smith+Nephew, therefore, supports the data sharing requirements of The International Committee of Medical 
Journal Editors (ICMJE) published on the 6th June 2017. In accordance, Smith+Nephew will consider requests to 
share individual (de-identified) participant data that underlie the results of any interventional clinical trial, as 
presented from the 1st July 2018 within an ICMJE associated journal. Requests made by researchers who provide 
a methodologically sound proposal will be considered. Requests may include data that underlie results presented 
in text, tables, figures, and appendices, together with data dictionaries. Availability of these data will begin nine
months and end 36 months after article publication. Data supplied may only be used by the researcher(s) named in 
the approved research proposal for the purposes of achieving the aims of the analyses specified therein. All 
proposals should be directed to datasharing.gcs@smith-nephew.com. To gain access, data requestors will need to 
sign a data access agreement.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 113 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
REFERENCES
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Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 114 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
22.
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with laparotomy incisions using negative-pressure therapy. Am J Surg. 2013;205(6):647-654.
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extremity fractures. J Orthop Trauma. 2012;26(1):37-42.
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Complications After Primary Hip Arthroplasty: A Pilot RCT. Surg Innov. 2015;22(5):488-495.
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Strugala V, Martin R. Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure 
Wound Therapy System for the Prevention of Surgical Site Complications. Surg Infect (Larchmt). 2017;18(7):810-
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Xia CY, Yu AX, Qi B, Zhou M, Li ZH, Wang WY. Analysis of blood flow and local expression of 
angiogenesisassociated growth factors in infected wounds treated with negative pressure wound therapy. Molecular 
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frequency diagnostic ultrasound: oedema reduction and new tissue accumulation. International wound journal. 
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surgical incisions. Medical technologies guidance published 9 May 2019. www.nice.org.uk/guidane/mtg43. 2019.
38.
O'Leary DP, Peirce C, Anglim B, et al. Prophylactic Negative Pressure Dressing Use in Closed Laparotomy Wounds 
Following Abdominal Operations: A Randomized, Controlled, Open-label Trial: The P.I.C.O. Trial. Ann Surg. 
2017;265(6):1082-1086.
39.
Cooper HJ, Bas MA. Closed-Incision Negative-Pressure Therapy Versus Antimicrobial Dressings After Revision Hip 
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Hester T, Mahmood S, Moftah F. Is Single Use Portable Incisional Negative Pressure Wound Therapy System 
Suitable for Revision Arthroplasty? Advances in Orthopedic Surgery. 2015;2015.
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Manoharan V, Grant AL, Harris AC, Hazratwala K, Wilkinson MP, McEwen PJ. Closed Incision Negative Pressure 
Wound Therapy vs Conventional Dry Dressings After Primary Knee Arthroplasty: A Randomized Controlled Study. J 
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Pellino G, Sciaudone G, Candilio G, et al. Preventive NPWT over closed incisions in general surgery: does age 
matter? International journal of surgery (London, England). 2014;12 Suppl 2:S64-s68.

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 115 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
43.
Leaper D, Wilson P, Assadian O, et al. The role of antimicrobial sutures in preventing surgical site infection. Annals of 
the Royal College of Surgeons of England. 2017;99(6):439-443.
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CDC. Surgical Site Infection (SSI) Event. Centers for Disease Control and Prevention (CDC), 2016. Available from: 
http://www.cdc.gov/nhsn/acute-care-hospital/ssi/.
45.
Dowsett C, Hampton, J., Myers, D., and Styche, T., . Use of PICO to improve clinical and economic outcomes in 
hard-to-heal wounds. Wounds International. 2017;8(2):52-58.
46.
Schwartz JA, Goss SG, Facchin F, Gendics C, Lantis JC. Single-use negative pressure wound therapy for the 
treatment of chronic lower leg wounds. Journal of Wound Care. 2015;24(Sup2):S4-S9.
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Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A Prospective, Randomized, Controlled Clinical Trial on the 
Efficacy of a Single-use Negative Pressure Wound Therapy System, Compared to Traditional Negative Pressure 
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& Nephew; 29 February 2016 2016.
49.
Wang E, Tang, R., Walsh, N., Stopher, L., Bharat, C., Ponosh, S., and Jansen, S, . Topical negative pressure therapy 
and compression in the management of venous leg ulcers: a pilot study. Wound Practice and Research 
2017;25(1):36-40.
50.
Hurd T, Trueman, P., and Rossington, A., . Use of a Portable, Single-use Negative Pressure Wound Therapy Device 
in Home Care Patients with Low to Moderately Exuding Wounds: A Case Series. Ostomy Wound Mangement. 
2014;60(3):30-36.
51.
Yamaguchi Y, Yanagi T, Sato K, et al. Portable negative-pressure wound therapy for pyoderma gangrenosum: 
Report of two cases. Journal of Dermatology. 2018;45(4):483-486.
52.
Canonico S, Campitiello, F., Della Corte, A., Padovano, V., Giannini, S., Luciani, D., Capra, P., Brambilla, R., Mazzei, 
S., Deotto, L., Chiarenza, S., Corbetta, F., Romanelli, M., Dini, V., Barbanera, S., and Gasperini, S., . Therapeutic 
Possibilities of Portable NPWT Initial Multidisciplinary Observation with the Negative Pressure Therapy Device. ACTA 
VULNOLOGICA. 2012;10:57-66.
53.
Hampton J. Providing cost-effective treatment of hard-to-heal wounds in the community through use of NPWT. British 
journal of community nursing. 2015;Community Wound Care:S14, S16-20.
54.
Sharpe A, Myers D, Searle R. Using single use negative pressure wound therapy for patients with complicated 
diabetic foot ulcers: An economic perspective. Wounds UK. 2018;14(4):89-93.
55.
Murphy S, Powell G. Pilonidal sinus wounds: Successful use of the novel negative pressure wound therapy device 
PICO. Wounds UK. 2013;9(4):80-83.
56.
Adeyemi A, Waycaster C. Cost-minimization Analysis of Negative Pressure Wound Therapy in Long-term Care 
Facilities. Wounds : a compendium of clinical research and practice. 2018;30(2):E13-e15.
57.
Menzies S, McGrath E, Ormond P, Barry R. Portable Negative Pressure Wound Therapy Leading to Rapid 
Resolution of Pain Associated with Poorly Healing Wounds of the Lower Limbs. J Clin Exp Dermatol Res. 
2017;8(425):2.
58.        Jon B. Suzuki, Randolph R. Resnik Wound dehiscence is a common early complication, which should be prevented 
with a good design of the flap and an adequate surgical technique, while small dehiscence can be managed with 
clorhexidine irrigation.Int. Wounds 2018; 5 (56)

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 116 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
APPENDICES
PROTOCOL AMENDMENT
Master Protocol Version 1.0 dated 7 Jan 2020 had to be amended to version 2.0 12 Mar 2021. The protocol amendment for 
this version is substantial and will go through UK ethics approval,
19.1.1 General Purpose
Reason for amendment:
-
Inclusion and Exclusion criteria changes to allow for recent pandemic. Exclusion criteria 
change was also changed to reflect on the IFU that allows for participants to be included in 
study despite use of anti-coagulants. 
-
Change of informed consent processes to allow for Verbal consenting by sites if this is 
deemed necessary due to COVID 19 pandemic, also change in dehisced wound consenting 
to allow for emergency consenting. 
-
Allow for a new pathway to recruiting dehisced wounds.
-
Change in number of sites to be included in the study. 
-
Changes were made to protocol to align with TMP-CD-05-01 REV D.1 as the template used 
is on REV A.
19.1.2 Rationale
Reason for amendment:
-
REV D.1 is effective template for protocol with changes based on ISO14155.2020 and other 
regulatories, the template used for this study is on REV A, it is therefore important to align 
with the latest revision for compliance purposes. 
-
Pathway for recruitment has changed due to COVID pandemic and therefore it is important 
to accommodate for the changes and therefore change informed consent processes, 
change into dehisced wound recruitment, change the number of sites to increased 
recruitment rates post various lockdowns in UK. 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 117 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
19.1.3 Effect on Study Status
No effect on study, the changes will only allow for better recruitment rates in light of the COVID-19 pandemic. PIS and ICF 
changes made will be effective from date of Ethics approval and new versions will be used from that point. 

Study Protocol—Device
A prospective, study to evaluate the safety 
and performance of PICO 14 in the 
management of acute and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 118 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by 
Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
19.1.4 Details

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 119 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Section
Smith+Nephew Logo 
2 Synopsis
Inclusion criteria
Current Text DD/MMM/YYYY 
Version #
07 JAN 2020 Version 1.0
Logo used is Smith&Nephew.
07 JAN 2020 Version 1.0
Revised Text DD/MMM/YYYY Version 
#
12 Sep 2021 VERSION 2.0
Changed logo throughout document 
Smith+Nephew
12 Sep 2021 VERSION 2.0
Additional description on Inclusion 
criterion for dehishced wounds, to allow 
for new pathway of recruitment. 
2 Synopsis 
Exclusion criteria 
07 JAN 2020 Version 1.0
Patients with bleeding disorders, 
or concomitant use of 
anticoagulants.
12 Sep 2021 VERSION 2.0
Removed this exclusion criteria.
2 Synopsis
07 JAN 2020 Version 1.0
Site numbers: up to seven. 
12 Sep 2021 VERSION 2.0
Site numbers: up to ten. 
7.3 Exclusion criteria
07 JAN 2020 Version 1.0
Patients with bleeding disorders, 
or concomitant use of 
anticoagulants.
12 Sep 2021 VERSION 2.0
Removed this exclusion criteria.
7.5 Informed consent 
07 JAN 2020 Version 1.0
No verbal consenting permitted 
12 Sep 2021 VERSION 2.0
Due to COVID-19 pandemic verbal 
consenting might be required by sites to 
achieve consent from participants who 
are unable to attend at the time of 
consent. Process for this will involve, site 
to provide PIS and full information on the 
study at least 24 hours prior to the Verbal 
call and consent. 
Verbal consent will be sought and the 
consenter will date and sign the ICF on 
the participant behalf, the participant will 
be screened thereafter and once in 

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 120 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
clinic they will be asked to sign and date 
the ICF personally.
7.5 Informed Consent 
Added language to align with REV A to 
REV D.1 protocol template. 
7.8.2 Withdrawal from 
study
Added language to align with REV A to 
REV D.1 protocol template. 
8.3 Data Management 
Added language to align with REV A to 
REV D.1 protocol template.
8.3.1 Data Review and 
Quality Assurance 
Added language to align with REV A to 
REV D.1 protocol template.
8.3.2 Retention Period 
Added language to align with REV A to 
REV D.1 protocol template.
9.1.7 Unscheduled Visit 
Additional language added from 
REV A to REV D.1 protocol 
template. “All information obtained 
during an unscheduled visit should be 
recorded in the source documents and 
on the appropriate CRF.”
9.1.10 Subject Pregnancy 
Additional language added from 
REV A to REV D.1 protocol 
template.” Pregnancy-related 
information will be collected until 
the end of the pregnancy.”
12 Adverse Events and 
Device Deficiencies 
REV A protocol template used for 
this section. 
REV D.1 protocol template used for this 
section. 
20.2 DATA sharing
REV A protocol template used for 
this section.
REV D.1 protocol template used for this 
section.

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 121 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
INSTRUCTIONS FOR USE
PRINCIPAL INVESTIGATOR OBLIGATIONS (ISO14155:2011)
1. General: 
a.
The role of the PI is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety, and well-being of the 
subjects involved in the clinical investigation. 
2. Qualification of the PI. The PI shall:
a.
be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation in accordance with this International Standard; 
evidence of such qualifications of the PI and key members of the investigation site team 
shall be provided to the Sponsor through up-to-date Curriculum Vitae (CV) or other 
relevant documentation,
b.
be experienced in the field of application and trained in the use of the investigational 
device under consideration,
c.
disclose potential conflicts of interest, including financial, that interfere with the conduct 
of the clinical investigation or interpretation of results, and
d.
Be knowledgeable with the method of obtaining informed consent.
3. Qualification of investigation site. The PI shall be able to demonstrate that the proposed 
investigation site:
a.
has the required number of eligible subjects needed within the agreed recruitment period, 
and
b.
Has one or more qualified investigators, a qualified investigation site team and adequate 
facilities for the foreseen duration of the clinical investigation.
4. Communication with the IEC. The PI shall: 
a.
provide the Sponsor with copies of any clinical-investigation-related communications 
between the PI and the IEC,
b.
Comply with the requirements described in 4.5 of ISO 14155:2011.

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 122 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
i.
Submit to the IEC the following information, any amendments and any additional 
documentation required by the IEC: the Protocol; IB or equivalent; informed 
consent form and any other written information provided to subjects; procedures for 
recruiting subjects and advertising materials, if any; a copy of the CV of the PI(s) 
for with the IEC has oversight.
ii.
Provide documentation of the IECs approval/favorable opinion, identifying the 
documents and amendments on which the opinion was based, to the Sponsor, prior 
to commencing the clinical investigation. 
iii.
Submit the following to the IEC if required by national regulations, the protocol or 
IEC, whichever is more stringent:
1.
SAEs
2.
Requests for deviations, and reports of deviations, if the deviation affects 
subject’s rights, safety, and well-being, or the scientific integrity of the clinical 
investigation. Document and report to the Sponsor and IEC a report of 
deviations made to protect the rights, safety, and well-being of human subjects 
under emergency circumstances. 
3.
Progress reports, including safety summary and deviations
4.
Amendments to any documents already approved by the IEC. 
5.
If applicable, notifications of suspension or premature termination
6.
If applicable, justification and request for resuming the clinical investigation 
after suspension. 
7.
Clinical investigation report or summary.
iv.
As a minimum, during the clinical investigation, the following information shall be 
obtained in writing from the IEC prior to implementation:
1.
Approval/favorable opinion of amendments
2.
Approval of the request for deviations that can affect the subject’s rights, safety,
and well-being or scientific integrity of the clinical investigation
3.
Approval for resumption of a suspended clinical investigation if applicable. 

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 123 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
c.
obtain the written and dated approval/favorable opinion of the IEC for the clinical 
investigation before recruiting subjects and implementing all subsequent amendments, if 
required,
d.
Promptly report any deviations from the protocol that affect the rights, safety or well-being 
of the subject or the scientific integrity of the clinical investigation, including those which 
occur under emergency circumstances, if required by the IEC, protocol or national 
regulations. In particular circumstances, the communication with the IEC can be 
performed by the Sponsor, partly or in full, in which case the Sponsor shall keep the 
Principal Investigator informed.
5. Informed consent process. The PI shall:
a.
General:
i.
Informed consent shall be obtained in writing from the subject and the process shall 
be documented before any procedure specific to the clinical investigation is applied 
to the subject; except when special circumstances for emergency treatments apply 
(see below)
b.
Process of obtaining informed consent. The general process for obtaining informed 
consent shall be documented in the protocol and shall comply with the following. These 
requirements also apply with respect to informed consent obtained from a subject’s 
legally authorized representative: 
i.
Ensure that the PI or his/her authorized designee conducts the informed consent 
process
ii.
Include all aspects of the clinical investigation that are relevant to the subject’s 
decision to participate throughout the clinical investigation
iii.
Avoid any coercion or undue improper influence on, or inducement of, the subject 
to participate
iv.
Not waive or appear to waive the subject’s legal rights
v.
Use native non-technical language that is understandable to the subject
vi.
Provide ample time for the subject to read and understand the informed consent 
form and to consider participation in the clinical investigation

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 124 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
vii.
Include personally dated signatures and the PI or an authorized designee 
responsible for conducting the informed consent process
viii.
Show how informed consent will be obtained in special circumstances (see below) 
where the subject is unable to provide him or herself, and 
ix.
Ensure important new information is provided to new and existing subjects 
throughout the clinical investigation. 
c.
Special circumstances for informed consent (the following provisions are subject to 
national regulations):
i.
Subject needing legally authorized representatives:  informed consent may be 
given by the legally authorized representative only if a subject is unable to make 
the decision to participate in a clinical investigation (e.g., infant, child, or juvenile, 
seriously ill or unconscious subject, mentally ill person, mentally handicapped 
person). In such cases, the subject shall also be informed about the clinical 
investigation within his/her ability to understand. 
ii.
Subject unable to read or write: informed consent shall be obtained through a 
supervised oral process if a subject or legally authorized representative is unable 
to read or write. An independent witness shall be present throughout the process. 
The written informed consent form and any other information shall be read aloud 
and explained to the prospective subject or his/her legally authorized representative 
and, whenever possible, either shall sign and personally date the informed consent 
form. The witness also signs and personally dates the informed consent for 
attesting that the information was accurately explained and that the informed 
consent was freely given. 
iii.
Emergency treatments: 
1.
For clinical investigations involving emergency treatments, when prior informed 
consent of the subject is not possible because of the subject’s medical 
condition, the informed consent of the subject’s legally authorized 
representative, if present, shall be requested. 

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 125 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
2.
When it is not possible to obtain prior informed consent from the subject, and 
the subject’s legally authorized representative, is not available, the subject may 
still be enrolled if a specific process has been described in the protocol. 
3.
Arrangements shall be made to inform the subject or legally authorized 
representative, as soon as possible, about the subject’s inclusion in the clinical 
investigation and about all aspects of the clinical investigation. 
4.
The subject shall be asked to provide informed consent for continued 
participation as soon as his/her medical condition allows. 
d.
The Principal Investigator may not enroll a subject without obtaining informed consent of 
the subject or his/her legally authorized representative only when the following conditions 
are fulfilled: the prospective subject fulfils the emergency conditions and is obviously in a 
life-threatening situation; no sufficient clinical benefits are anticipated from the currently 
available treatment; there is a fair possibility that the life-threatening risk to the 
prospective subject can be avoided if the investigational device is used; anticipated risks 
are outweighed by the potential benefits of applying the investigational device ; the legally 
authorized representative cannot be promptly reached and informed. 
e.
Information provided to the subject. All information pertinent to the clinical investigation, 
including at least the following, shall be provided in writing and in native, non-technical 
language that is understandable to the subject (or the subject’s legally authorized
representative):
i.
Description and purpose
ii.
Potential benefits
iii.
Risks and inconveniences or the subject and, when applicable, for any embryo, 
fetus or nursing infant
iv.
Alternative procedures
v.
Confidentiality
vi.
Compensation
vii.
Anticipated expenses, if any, to be borne by the subject for participating in the 
clinical investigation
viii.
Information on the role of Sponsor’s representative in the clinical investigation

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 126 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
ix.
Contact persons
x.
Statement declaring that new findings or the reasons for any amendment to the 
protocol that affect the subject’s continued participation shall be made available to 
the subject. 
xi.
Statement indicating that, upon the subject’s approval, the subject’s personal 
physician will be informed of the subject’s participation in the clinical investigation
xii.
Termination procedures
f.
Informed consent signature shall contain the following: 
i.
The voluntary agreement to participate in the clinical investigation and follow the 
investigator’s instructions
ii.
A statement declaring that refusal of participation incurs no penalty for the subject
iii.
A statement declaring that discontinuation at any time incurs no penalty for the 
subject
iv.
A statement with regard to the possible consequences of withdrawal
v.
An acknowledgment of the information provided and confirmation that all the 
subject’s questions were answered
vi.
A statement confirming that the subject or his/her legally authorized representative 
agrees to the use of the subject’s relevant personal data for the purpose of the 
clinical investigation
vii.
A statement confirming that the subject or his/her legally authorized representative 
agrees 
that 
Sponsor’s 
representatives, 
regulatory 
authorities and 
IEC
representatives will be granted direct access to the subject’s medical records. 
g.
New information: if new information becomes available that can significantly affect a 
subject’s future health and medical care that information shall be provided to the subject
affected in written form. If relevant, all affected subjects shall be asked to confirm their 
continuing consent in writing. 
h.
ensure compliance with the applicable regulatory requirements and ethical principles for 
the process of obtaining informed consent, and
i.
Ensure and document appropriate training if an authorized designee is appointed to 
conduct the informed consent process.

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 127 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
6. Compliance with the protocol. The Principal Investigator shall:
a.
indicate his/her acceptance of the protocol in writing,
b.
conduct the clinical investigation in compliance with the protocol,
c.
create and maintain source documents throughout the clinical investigation and make 
them available as requested during monitoring visits or audits,
d.
ensure that the investigational device is used solely by authorized users as specified in 
6.2, and in accordance with the protocol and instructions for use,
e.
propose to the Sponsor any appropriate modification(s) of the protocol or investigational 
device or of the use of the investigational device,
f.
refrain from implementing any modifications to the protocol without agreement from the 
Sponsor, IEC and regulatory authorities, if required,
g.
document and explain any deviation from the approved protocol that occurred during the 
course of the clinical investigation,
h.
ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation,
i.
ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable,
j.
ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
Sponsor in the CRF and in all required reports,
k.
maintain the device accountability records,
l.
allow and support the Sponsor to perform monitoring and auditing activities,
m. be accessible to the monitor and respond to questions during monitoring visits,
n.
allow and support regulatory authorities and the IEC when performing auditing activities,
o.
ensure that all clinical-investigation-related records are retained as required taking 
measures to prevent accidental or premature destruction, and
p.
Review and sign the clinical investigation report, as applicable.
7. Medical care of subjects. The Principal Investigator shall
a.
provide adequate medical care to a subject during and after a subject's participation in a 
clinical investigation in the case of adverse events, 
b.
inform the subject of the nature and possible cause of any adverse events experienced,

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 128 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
c.
provide the subject with the necessary instructions on proper use, handling, storage, and 
return of the investigational device, when it is used or operated by the subject,
d.
inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required,
e.
provide the subject with well-defined procedures for possible emergency situations 
related to the clinical investigation, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, as 
needed,
f.
ensure that clinical records are clearly marked to indicate that the subject is enrolled in a 
particular clinical investigation,
g.
if appropriate, subjects enrolled in the clinical investigation shall be provided with some 
means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided),
h.
inform, with the subject's approval or when required by national regulations, the subject's 
personal physician about the subject's participation in the clinical investigation, and 
i.
Make all reasonable efforts to ascertain the reason(s) for a subject's premature 
withdrawal from the clinical investigation while fully respecting the subject's rights.
8. Safety reporting. The Principal Investigator shall:
a.
record every adverse event and observed device deficiency, together with an 
assessment,
b.
report to the Sponsor, without unjustified delay, all serious adverse events and device 
deficiencies that could have led to a serious adverse device effect; this information shall 
be promptly followed by detailed written reports, as specified in the protocol,
c.
c) report to the IEC serious adverse events and device deficiencies that could have led 
to a serious adverse device effect, if required by the national regulations or protocol or 
by the IEC,
d.
report to regulatory authorities serious adverse events and device deficiencies that could 
have led to a serious adverse device effect, as required by the national regulations, and

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 129 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
e.
supply the Sponsor, upon Sponsor's request, with any additional information related to 
the safety reporting of a particular event.
THE PATIENT AND OBSERVER SCAR ASSESSMENT SCALE (POSAS).
The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales 
contain six items that are scored numerically and make up a ‘Total Score’ of the Patient 
and Observer Scale. The sum altogether will give the ‘Total Score’ of the POSAS. Besides 
the 10-step scale, category boxes are available to score nominal parameters (e.g. type of 
colour). Moreover, the patient and observer also score their ‘Overall Opinion’.
The six items and Total Score of the Patient and Observer Scale POSASv2.0
Each item of both scales has a 10-point score, with 10 indicating the worst imaginable 
scar or sensation. The lowest score is ‘1’, and corresponds to the situation of normal skin 
(normal pigmentation, no itching etc), and goes up to the worst imaginable. The Total 
Score of both scales can be simply calculated by summing up the scores of each of the 
six items. The Total Score will therefore range from 6 to 60. One may argue if the results 
of the separate items should be weighted to come to a more accurate Total Score. To 
date no convincing evidence is available that indicates that weighting improves the 
accuracy of the Total Score. Currently, the significance of weighting parameters is under 
investigation. Besides the six items the ‘Overall Opinion’ of the scar quality is scored 
separately of both patients and observers.
Categories (Observer Scale POSASv2.0)
Category boxes are provided to score the items not only quantitatively on a ten step scale 
but also qualitatively. In this way not only the severity but also the direction of the disorder 
(e.g., hypopigmentation or hyperpigmentation) is addressed. The categories are not 
included in calculating the Total Score of the POSAS. However, they are considered 
clinically relevant for complete documentation.
Overall Opinion (Patient and Observer Scale POSASv2.0)

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 130 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
Both the patient and the observer are asked to give their Overall Opinion on the 
appearance of the scar. Again, a 10-point scale is used in which 10 corresponds to the 
worst imaginable scar. The ‘Overall Opinion’ is not part of the Total Score of the Observer 
and Patient Scale of the POSAS.
Observer Scale POSASv2.0
In the POSASv2.0 observers rate vascularity, pigmentation, pliability, thickness, relief and 
surface area.
The directions for use of the different parameters of the Observer Scale POSASv2.0 are 
as follows (all parameters should be compared to normal skin at a comparable anatomical 
site whenever possible):
Vascularity: Presence of vessels in scar tissue assessed by the amount of redness, tested 
by the amount of blood return after blanching with a piece of Plexiglas Pigmentation: 
Brownish coloration of the scar by pigment (melanin); apply Plexiglas to the skin with 
moderate pressure to eliminate the effect of vascularity
Thickness: Average distance between the subcuticular-dermal border and the epidermal 
surface of the scar Relief: The extent to which surface irregularities are present (preferably 
compared with adjacent normal skin) Pliability: Suppleness of the scar tested by wrinkling 
the scar between the thumb and index finger Surface area: Surface area of the scar in 
relation to the original wound area
Furthermore the Overall Opinion is assessed as well as categories for each of the six 
items:
Vascularity*: pale | pink | red | purple | mix Pigmentation: hypo | hyper | mix Thickness*: 
thicker | thinner Relief*: more | less | mix Pliability*: supple | stiff | mix Surface area*: 
expansion | contraction | mix
* If more options are applicable please select the most suitable option.
Patient Scale POSASv2.0

Study Protocol—Device
A prospective, study to evaluate the safety and 
performance of PICO 14 in the management of acute 
and chronic wounds
Number: 
PICO14.WND.PRO.2019.03
Version: 2.0, 12Sep2021
Page: Page 131 of 131
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols
The Patient Scale contains six questions applying to pain, itching, colour, pliability, 
thickness and relief. Because it was too difficult for patients to make the distinction 
between pigmentation and vascularity, both characteristics were captured in one item: 
colour. Each of the six items on both scales has a 10-point score, with 10 indicating the 
worst imaginable scar or sensation. The lowest score is ‘1’, and corresponds to the 
situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst 
imaginable.
The Patient Scale POSASv2.0 contains the following questions: 1. has the scar been 
painful the past few weeks? 2. Has the scar been itching the past few weeks? 3. Is the 
scar colour different from the colour of your normal skin at present? 4. Is the stiffness of 
the scar different from your normal skin at present? 5. Is the thickness of the scar different 
from your normal skin at present? 6. Is the scar more irregular than your normal skin at 
present?
These six items add up to the Total Score of the Patient Scale. Besides those six 
questions, the patient is asked to provide an Overall Opinion concerning scar quality.
Conditions for assessment
Ideally, scars should be evaluated clinically under the same conditions such as room 
temperature and humidity. At the time of measurement the skin and scar tissue of the 
patient should be adapted to this situation. Especially pigmentation may change because 
of seasonal variation.