A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border
Conditions: Wound
Sponsor: Smith & Nephew Orthopaedics AG

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 1 of 90 
 
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 
Sponsor Name and 
Address: 
T.J. Smith and Nephew Limited  
101 Hessle Road, 
Hull HU3 2BN, England 
 
Investigational and 
Comparator Product: 
ALLEVYN Gentle Border wound dressing 
No comparator 
 
 
Protocol Authors: 
Hilary Watkins, Clinical Research Analyst 
Michelle Foster, Senior Biostatistician 
Kareen Chu, Clinical Study Manager 
 
 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 2 of 90 
 
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 
 
SIGNATURES 
1.1 
PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
This page will be returned to T.J. Smith and Nephew Limited and a copy will be retained at the 
investigational site. 
I have read the attached protocol entitled “A Prospective, Multi-center, Post-Market Clinical Follow-
Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border,” version 3.0, dated 
21 JUN 2019, and agree to abide by all provisions set forth herein. 
I agree to comply with the Investigator’s Obligations stipulated in Section 27.1 of the protocol,  
I agree to ensure that the confidential information contained in this document will not be used for 
any purpose other than the conduct of the described clinical investigation without the prior written 
consent of T.J. Smith and Nephew Limited. 
 
 
 
Name, Address,  
Professional Position 
Signature 
Date Signed 
(DD/MMM/YYYY) 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 4 of 90 
 
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 
 SYNOPSIS 
Title of Study: 
A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to 
Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border 
Study Design: 
x 
Prospective 
x 
Multi-center 
x 
Single-arm 
Study Type: 
Observational Study 
Study Product:  
ALLEVYN Gentle border is a triple layer foam dressing consisting of a 
highly absorbent hydrocellular foam pad held between a perforated 
wound contact layer (WCL) which is coated with a soft silicone gel 
adhesive and a highly permeable outer top film. 
Comparison Group: 
No comparison groups. 
Study Purpose: 
PMCF study to assess clinical performance and safety of ALLEVYN 
Gentle Border with new wound contact layer to support performance 
claims. 
Primary Objective: 
To demonstrate clinical performance of ALLEVYN Gentle Border as 
measured by reduction in the size of the wound area (cm2) over 4 week 
treatment period in patients with chronic and acute; full-thickness, partial 
thickness or shallow granulating, exuding wounds including pressure 
ulcers, leg ulcers, diabetic foot ulcers and dehisced surgical wounds. 
Secondary Objective: 
To generate safety and performance related data of ALLEVYN Gentle 
Border in patients with chronic and acute wounds.  
Other Objective: 
None 
Statistical Rationale: 
It is assumed that the actual reduction in the mean wound area from 
baseline to 28 days is 3cm2 with a standard deviation of 5cm2. 
Assuming this data holds true it can be calculated that 26 subjects 
would provide 83% power to show a statistically significant reduction in 
the mean wound area from baseline to 28 days. Accounting for the 
protocol modifications outlined in Section 21, it is recommended to 
increase the total patient recruitment target to 35 subjects, providing 
93% power. Allowing for a 15% lost to follow up rate, 40 subjects will 
be recruited into this study.  

Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 5 of 90 
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 
Sample Size: 
40 subjects, with a minimum of 10 subjects in each group of Acute 
Wounds and Chronic Wounds. 
Number of Study 
Sites: 
Up to 8 study sites 
Targeted Global 
Regions: 
Up to 3 countries in Europe 
Inclusion Criteria: 
1.
Signed written informed consent.
2.
18 years of age or older.
3.
Willing and able to make all required study visits.
4.
Able to follow instructions and deemed capable of completing the
CWIS questionnaire, Patient Assessment Scale and Pain Scale.
5.
Presence of a moderately to highly exuding wound of at least 3cm2
in size.
6.
Presence of a chronic wound of at least 6 weeks duration at the
point of enrollment; full-thickness, partial thickness or shallow
granulating wounds.
Chronic wounds include:
o
pressure ulcers or
o
leg ulcers or
o
diabetic foot ulcers.
or  
Presence of an acute wound at the point of enrolment; full-
thickness, partial thickness or shallow granulating wounds.  
Acute wounds include: 
o
dehisced surgical or
o
traumatic wounds.
7.
The patient has a wound size which can be treated with the available
sizes and shapes of ALLEVYN Gentle Border. Cutting of the dressing is 
allowed, if needed. ALLEVYN Gentle Border can be cut and an 
aseptic technique should be used with cutting the dressing. Ensure any 
exposed foam areas are covered with an appropriate film dressing 
taking care not to cover the entire dressing.

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 6 of 90 
 
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 
Exclusion Criteria: 
1. Subjects with confirmed or suspected clinically infected reference 
wound.  
2. Reference wound undergoing treatment with compression therapy. 
3. Contraindications or hypersensitivity to the use of the ALLEVYN 
Gentle Border. 
4. Participation in the treatment period of another clinical trial within 30 
days of Visit 1 or planned participation overlapping with this study. 
5. Subjects with skin features (e.g. tattoos, skin color, pre-existing 
scarring) which, in the opinion of the Investigator, could interfere with 
the study assessments. 
6. Subjects who have participated previously in this clinical trial. 
7. Subjects with a history of poor compliance with medical treatment. 
8. Subjects with a medical or physical condition that, in the opinion of 
the Investigator, would preclude safe subject participation in the 
study 
Study Duration: 
Total Study Duration: 26 months 
Enrolment Period: 13 months 
Treatment Duration: 4 week Follow-up (5 study visits) 
Primary endpoint: 
The absolute reduction in wound area from baseline to end of study visit. 
Secondary endpoints: x 
Absolute reduction in area from baseline to days 7(+/-3), 14 (+/-3), 21 
(+/-3). 
x 
Absolute reduction in depth and volume from baseline to visits 2, 3, 
4 and end of study visit. 
x 
Percentage reduction in area, depth and volume from baseline visit 
to visits 2, 3, 4 and end of study visit. 
x 
Exudate management (fluid handling ability including leakage and 
percentage strikethrough)  
x 
Exudate type, amount and viscosity 
x 
Odour control – during wear and during dressing change  
x 
Dressing change frequency 
x 
Condition of surrounding skin 
x 
Signs of clinical infection 
x 
Healing of reference wound status 
x 
Dressing wear time 
x 
Dressing retention, presence of bunching up and percentage 
dressing lift.  
x 
Comfort during wear 
x 
Showerproof qualities 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 7 of 90 
 
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 
x 
Pain on application, during treatment and on dressing removal 
 
Patient Reported Outcome (PRO): 
 
x 
To assess the change from baseline in subject reported outcomes 
using the Cardiff Wound Impact Schedule (CWIS) 
Other exploratory 
endpoint: 
None  
Safety Data 
Adverse Events and Device Deficiencies data will be collected,  
such as AEs, SAEs, ADEs, SADEs, USADEs 
 
 
 
 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 8 of 90 
 
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 SCHEDULE  
Table 1: Study Visits and Assessments 
Schedule of 
Events 
Key Visits  
Other Visits  
Visit 1 
(Baseline) 
 
 
Day 0 
Visit 2 
 
 
 
Day 7  
(+/-3) 
Visit 3 
 
 
 
Day 14 
(+/-3) 
Visit 4 
 
 
 
Day 21 
(+/-3) 
End of 
Study 
Visit 5 
 
Day 28 
(+/-3) 
Routine 
Dressing 
Changes 
Treatment 
Discontin
uation 
(before 
end of 
study) 
Informed 
Consent 
√ 
 
 
 
 
 
 
Demographics/ 
Medical History 
√ 
 
 
 
 
 
 
Verify Inclusion/ 
Exclusion Criteria 
√ 
 
 
 
 
 
 
Allocate Study ID 
Number 
√ 
 
 
 
 
 
 
Concomitant 
Medication 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
CWIS Patient 
Questionnaire 
√ 
√ 
√ 
√ 
√ 
 
√ 
Patient Pain 
Scale 
√ 
√ 
√ 
√ 
√ 
√ 
 
Patient 
Assessment 
 
√ 
√ 
√ 
√ 
√ 
 
Wound 
Assessment 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
Photograph 
Dressing in situ 
Before Removal 
 
√ 
√ 
√ 
√ 
√ 
√ 
Dressing Change 
 
√ 
√ 
√ 
 
√ 
 
Photograph 
Wound Before 
Dressing 
Application  
√ 
√ 
√ 
√ 
√ 
√ 
√ 
Dressing 
Performance 
√ 
√ 
√ 
√ 
√ 
√ 
 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 9 of 90 
 
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 
Key Visits  
Other Visits  
Visit 1 
(Baseline) 
 
 
Day 0 
Visit 2 
 
 
 
Day 7  
(+/-3) 
Visit 3 
 
 
 
Day 14 
(+/-3) 
Visit 4 
 
 
 
Day 21 
(+/-3) 
End of 
Study 
Visit 5 
 
Day 28 
(+/-3) 
Routine 
Dressing 
Changes 
Treatment 
Discontin
uation 
(before 
end of 
study) 
Adverse Event 
(AE) Assessment  
√ 
√ 
√ 
√ 
√ 
√ 
√ 
Record Device 
Deficiencies (DD) 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
End of Study 
/Exit Form 
 
 
 
 
√ 
 
√ 
 
 
 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 10 of 90 
 
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 
 CONTENTS 
3.1 
TABLE OF CONTENTS 
 
Signatures ......................................................................................................................................... 2 
1.1 
Principal Investigator Signature Page ........................................................................................ 2 
1.2 
Sponsor Approval ...................................................................................................................... 3 
 
Synopsis ........................................................................................................................................... 4 
 
Contents .......................................................................................................................................... 10 
3.1 
Table of Contents ..................................................................................................................... 10 
3.2 
Table of Tables ........................................................................................................................ 13 
3.3 
Table of Figures ....................................................................................................................... 13 
3.4 
List of Abbreviations ................................................................................................................. 15 
 
Introduction .................................................................................................................................... 17 
4.1 
Literature Summary ................................................................................................................. 18 
4.2 
Study Purpose ......................................................................................................................... 19 
4.3 
Safety Considerations .............................................................................................................. 19 
4.3.1 
Benefits .............................................................................................................................. 20 
4.3.2 
Other Precautions.............................................................................................................. 20 
 
Objective(s) ..................................................................................................................................... 20 
5.1 
Primary Objective ..................................................................................................................... 21 
5.2 
Secondary Objective(s) ............................................................................................................ 21 
5.3 
Claims ...................................................................................................................................... 21 
 
Investigational Product ................................................................................................................. 21 
6.1 
Identification ............................................................................................................................. 22 
6.1.1 
Investigational Product ...................................................................................................... 22 
6.1.2 
Comparator Treatment ...................................................................................................... 25 
6.1.3 
Ancillary Product ................................................................................................................ 25 
6.2 
Product Use .............................................................................. Error! Bookmark not defined. 
6.2.1 
Medical Personnel Training ............................................................................................... 25 
6.2.2 
Application of ALLEVYN Gentle Border ............................................................................ 25 
6.2.3 
Dressing Change ............................................................................................................... 26 
6.3 
Packaging and Labeling ........................................................................................................... 27 
6.3.1 
Labeling of Investigational Product ................................................................................... 27 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 11 of 90 
 
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 
6.3.2 
Storage of ALLEVYN Gentle Border ................................................................................. 27 
6.4 
Product Accountability Procedures .......................................................................................... 27 
 
Subject Enrollment and Withdrawal ............................................................................................. 28 
7.1 
Subject Population ................................................................................................................... 28 
7.2 
Inclusion Criteria ...................................................................................................................... 28 
7.3 
Exclusion Criteria ..................................................................................................................... 29 
7.4 
Screening ................................................................................................................................. 30 
7.5 
Informed Consent .................................................................................................................... 30 
7.6 
Enrolment ................................................................................................................................. 30 
7.7 
Lost to follow-up ....................................................................................................................... 30 
7.8 
Withdrawal ............................................................................................................................... 31 
7.8.1 
Withdrawal from Treatment ............................................................................................... 31 
7.8.2 
Subject’s Withdrawal of Consent to Participate in Study .................................................. 32 
7.8.3 
Use of Data Following Withdrawal .................................................................................... 32 
 
Study Design .................................................................................................................................. 32 
8.1 
Study Design ............................................................................................................................ 32 
8.1.1 
Treatment Allocation.......................................................................................................... 33 
8.1.2 
Blinding .............................................................................................................................. 33 
8.2 
Study Endpoints ....................................................................................................................... 33 
8.2.1 
Primary Endpoint ............................................................................................................... 33 
8.2.2 
Secondary Endpoints ........................................................................................................ 33 
8.2.3 
Other Endpoints ................................................................................................................. 34 
8.3 
Methods Used to Minimize Bias and Maximize Validity .......................................................... 34 
 
Study Procedures .......................................................................................................................... 34 
9.1 
Visits and Examinations ........................................................................................................... 34 
9.1.1 
Summary ........................................................................................................................... 34 
9.1.2 
Study Visit 1 - Initial Visit (Baseline Visit, day 0) ............................................................... 35 
9.1.3 
Study Visit 2 (day 7, ±3), Visit 3 (day 14, ±3), Visit 4 (day 21, ±3) .................................... 36 
9.1.4 
Routine Dressing Change Visit (between key study visits, if required) ............................. 37 
9.1.5 
End of Study Visit (day 28, ±3) .......................................................................................... 38 
9.1.6 
Unscheduled Visits ............................................................................................................ 39 
9.1.7 
Concomitant Medications and Therapies .......................................................................... 39 
9.1.8 
Discontinued Subjects ....................................................................................................... 40 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 12 of 90 
 
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 
9.1.9 
Subject Pregnancy ............................................................................................................ 41 
9.2 
Study Methods and Measurements ......................................................................................... 41 
9.2.1 
Pressure Ulcer Classification ............................................................................................ 41 
9.2.2 
Diabetic Foot Ulcer (DFU) Classification ........................................................................... 42 
9.2.3 
Photographs and Wound Size Measurements .................................................................. 43 
9.2.4 
Reference Wound Assessments with modified Bates-Jensen Wound Assessment Tool 
(BWAT) .............................................................................................................................. 44 
9.2.5 
Patient Assessment Scale ................................................................................................. 44 
9.2.6 
Patient Pain Scale ............................................................................................................. 45 
9.2.7 
Cardiff Wound Impact Questionnaire (CWIS) ................................................................... 46 
9.2.8 
Dressing and Clinical Performance ................................................................................... 46 
9.2.9 
Biological Samples ............................................................................................................ 47 
9.3 
Quality of Life ........................................................................................................................... 47 
 
Statistical Design ........................................................................................................................... 48 
10.1 
General .................................................................................................................................... 48 
10.2 
Analysis Populations ................................................................................................................ 48 
10.3 
Baseline Data ........................................................................................................................... 49 
10.4 
Efficacy Analysis ...................................................................................................................... 49 
10.4.1 
Analysis of Primary Endpoint ............................................................................................ 49 
10.4.2 
Analysis of Secondary Endpoints ...................................................................................... 50 
10.5 
Safety Analyses ....................................................................................................................... 51 
10.6 
Interim Analyses ...................................................................................................................... 52 
 
Sample Size Justification .............................................................................................................. 52 
 
Adverse Events and Device Deficiencies .................................................................................... 53 
12.1 
Definitions ................................................................................................................................ 53 
12.1.1 
Adverse Event ................................................................................................................... 54 
12.1.2 
Adverse Device Effect ....................................................................................................... 54 
12.1.3 
Serious Adverse Events and Serious Adverse Device Effects ......................................... 55 
12.1.4 
Anticipated/Unanticipated Serious Adverse Device Effect ................................................ 55 
12.1.5 
Severity .............................................................................................................................. 55 
12.1.6 
Device Deficiency .............................................................................................................. 56 
12.2 
AE Coding Dictionary ............................................................................................................... 56 
12.3 
Reporting Procedures .............................................................................................................. 57 
12.4 
Unblinding of Investigational Product ...................................................................................... 59 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 13 of 90 
 
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 
12.5 
Follow-up of Subjects with Adverse Events ............................................................................. 59 
12.5.1 
Ongoing Adverse Events at Study Discontinuation ........................................................... 59 
 
Investigator Obligations ................................................................................................................ 60 
 
Sponsor and Monitor Responsibilities ........................................................................................ 60 
14.1 
Contract Research Organization ............................................................................................. 60 
14.2 
Site Qualification Visit .............................................................................................................. 61 
14.3 
Site Initiation Visit ..................................................................................................................... 61 
14.4 
Sponsor Audits and Regulatory Inspection .............................................................................. 61 
14.5 
Close-out Visit .......................................................................................................................... 61 
 
Protocol Amendments ................................................................................................................... 61 
 
Confidentiality of the Study .......................................................................................................... 62 
 
Statements of Compliance ............................................................................................................ 62 
 
End of Study ................................................................................................................................... 62 
 
Publication Policy .......................................................................................................................... 63 
19.1 
Publication of Study Data ......................................................................................................... 63 
19.2 
Data Sharing ............................................................................................................................ 63 
 
References ...................................................................................................................................... 63 
 
Appendices ..................................................................................................................................... 65 
21.1 
Protocol Amendment ............................................................................................................... 65 
21.2 
Instructions For Use ................................................................................................................. 74 
21.3 
Equipment and Special Instructions ........................................................................................ 74 
21.4 
Bates-jensen wound assessment tool and instructions for use ............................................... 74 
21.5 
Health Economic Outcome Measures/ Quality of Life Measures ............................................ 79 
21.6 
Additional Information .............................................................................................................. 85 
21.7 
Principal Investigator Obligations (ISO 14155:2011) ............................................................... 85 
3.2 
TABLE OF TABLES  
Table 1: Study Visits and Assessments ........................................................................................................ 8 
Table 2: ALLEVYN Gentle Border Size and Ordering Information.............................................................. 24 
Table 3: Categories of Adverse Event ......................................................................................................... 53 
3.3 
TABLE OF FIGURES 
Figure 1: Composite structure of all ALLEVYN Gentle Border Dressings .................................................. 22 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 14 of 90 
 
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 2: ALLEVYN Gentle Border Shapes ................................................................................................ 24 
Figure 3: AGB Application Instruction ......................................................................................................... 26 
Figure 4: Stages before dressing change ................................................................................................... 27 
Figure 5: Evaluation and Reporting of AE ................................................................................................... 58 
Figure 6: Evaluation and Reporting of DD ................................................................................................... 59 
 
 
 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 15 of 90 
 
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 
3.4 
LIST OF ABBREVIATIONS  
Abbreviation 
Definition 
ADE 
Adverse Device Effect(s) 
AE 
Adverse Event(s) 
AGB 
Allevyn Gentle Border 
BWAT 
Bates-Jensen Wound Assessment Tool 
CE 
Conformité Européene  
cm 
Centimeter 
CRF 
Case Report Form(s) 
CRO 
Contract Research Organization  
CV 
Curriculum Vitae 
CWIS 
Cardiff Wound Impact Schedule 
DD 
Device Deficiency(ies) 
DFU 
Diabetic Foot Ulcer 
EC 
Ethics Committee 
EPUAP 
European Pressure Ulcer Advisory Panel 
FU 
Follow-Up 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonization  
IFU 
Instructions for Use 
ISF 
Investigator Site File 
ITT 
Intention to Treat population 
LTFU 
Lost to Follow Up 
LU 
Leg Ulcer 
MedDRA 
Medical Dictionary for Regulatory Activities  
MVP 
Moisture Vapour Permeability 

 
Study Protocol—Device 
 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 16 of 90 
 
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 
Abbreviation 
Definition 
NA or N/A 
Not Applicable 
N (or n) 
Total Sample Size (or subgroup sample size) 
PI 
Principal Investigator 
PMA 
Pre-Market Authorization 
PP 
Per-protocol Population 
Reference 
Wound 
Identified Study Wound 
S&N 
T.J. Smith and Nephew Limited, England 
SADE 
Serious Adverse Device Effect(s) 
SAE 
Serious Adverse Event(s) 
SAF 
Safety Population 
SAP 
Statistical Analysis Plan 
TÜV 
Technischer Überwachungsverein/ Technical Inspection Association 
USADE 
Unanticipated Serious Adverse Device Effect(s) 
WCL 
Wound Contact Layer 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 17 of 90 
 
 
 
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 
 INTRODUCTION 
Chronic wounds, independent from their origin or body location, significantly impact patients’ 
quality of life. These chronic wounds fail to heal and remain stuck in an inflammatory phase. In 
developed countries, the incidence of chronic wounds has increased in recent years (9), possibly 
due to an aging population with an abundance of concurrent illnesses such as diabetes, 
hypertension, obesity, and peripheral vascular disease. 
 
Closure of complex wounds, including chronic wounds, post-surgical wounds, and trauma wounds 
is often achieved through secondary intention. Although these wound types have different 
etiologies and underlying pathophysiology, their treatment follows a similar course. Wound closure 
by secondary intention can be supported by a wide range of wound dressings designed specifically 
for this purpose. An ideal dressing must provide the following at a minimum: 
• a barrier to exogenous contamination and infection 
• adequate management of wound exudate 
• maintenance of a moist wound healing environment 
 
Failure of a dressing to deliver these fundamental features will negatively impact the ability of a 
complex wound to heal and may allow the wound to deteriorate. Failure to prevent contamination 
may allow a wound to become infected. Inability to manage moderate to high exudate volume may 
lead to maceration of the peri-wound skin, which can lead to further wound breakdown if untreated. 
At the same time, a dressing should not allow a wound to dry out; the dressing should maintain a 
moist wound healing environment. The consequences of wound deterioration vary, but can result 
in protracted wound healing or may cause an otherwise preventable hospital episode for surgical 
management or closure.  
The present study will be the second clinical trial to evaluate the actual use of ALLEVYN Gentle 
Border (AGB) in clinical practice. In this study, the performance of a new Wound Contact Layer 
(WCL) will be assessed. The reason for this change was to create a more consistent size in the 
perforation of the WCL. The new layer is non-adherent to the wound, minimizes stripping of 
epidermal cells and minimizes the disruption of the healing tissue. In this study, 40 subjects with 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 18 of 90 
 
 
 
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 
acute wounds and chronic wounds older than 6 weeks will be enrolled to assess the performance 
of AGB with the new Wound Contact Layer (WCL) by the reduction of wound area up to 4 weeks. 
A summary of known and potential risks and benefits to humans of the test article can be found in 
the Package Insert and Instructions for Use (IFU). 
4.1 
LITERATURE SUMMARY 
The data provided in the literature suggest that the dressing meets clinician’s needs based on 
dressing wear time, exudate management, wound pain and trauma on dressing removal (2). No 
wound infections have been identified within the adverse event (AE) profile for ALLEVYN Gentle 
Border either from PMS or manufacturer sponsored clinical studies (10).  
 
In addition, several clinical studies utilising AGB have been identified demonstrating evidence of 
the safety and performance of AGB in wound management. A previous comparative clinical study 
evaluating the use of AGB compared to a competitor dressing demonstrated the safe and effective 
use in 21 patients with chronic and acute wounds. No major safety issues were highlighted with 
either dressing and clinicians were satisfied with exudate handling in all AGB dressing changes. 
(10). A study by Grothier et al. (2009) showed that AGB was rated highly by the investigating 
clinicians, with an 87% level of acceptance for the range of clinical indications treated. Satisfaction 
with the dressing’s exudate management was reported in 86% of dressing changes. Another case 
series, including 153 patients, demonstrated that the AGB dressing was effective in improving 
wound outcomes, in particular reducing wound area, depth and level of exudate in routine clinical 
practice. Significant reduction in wound area and depth by the final assessment was observed 
(p<0.001; Hurd et al, 2009). Both of these studies, alongside many others (including comparative 
studies), have demonstrated the safe and effective use of ALLEVYN Gentle Border in wound 
management (10). 
 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 19 of 90 
 
 
 
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 
4.2 
STUDY PURPOSE 
The purpose of this study is to assess the clinical performance and the safety of ALLEVYN Gentle 
Border with new wound contact layer (WCL).  
4.3 
SAFETY CONSIDERATIONS 
Precautions for the use of AGB, as specified in the current Instructions for Use (IFU), are:  
x 
Care should be taken when using the dressing under medical devices near the nose and 
mouth, where moisture can build up and affect adherence, leading to dressing movement.  
x 
The use of ALLEVYN Gentle Border, as part of a program of prophylaxis against the 
development of a pressure ulcer, does not preclude the need to continue to develop and follow 
a comprehensive pressure ulcer prevention protocol (e.g. regular repositioning, appropriate 
support surfaces, skin care and frequent skin assessments). 
x 
Due to the gentle adhesive used, do not use this dressing to secure other medical devices to 
the patient. 
x 
If reddening of the skin or signs of sensitization appear, discontinue use. 
x 
Cutting the dressing will compromise the bacteria barrier and showerproof properties of the 
dressing. 
x 
Do not immerse the dressing in water. 
x 
Do not use with oxidizing agents such as hypochlorite solutions (e.g. EUSOL) or hydrogen 
peroxide as these can reduce the absorbency of the dressing. 
x 
Single use only, if used on more than one patient cross contamination or infection may occur. 
x 
Once opened, do not retain unused dressings for application at a later date. 
x 
If used on infected wounds, the infection should be managed as per local clinical protocol.  
Risks associated with the use of AGB within the present study will be mitigated as follows: 
Study personnel will be trained in the correct use of AGB prior to applying the dressing to the 
wounds of study subjects. 
x 
Study personnel will be trained on the study protocol. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 20 of 90 
 
 
 
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 personnel will be directed to carefully follow the inclusion and exclusion criteria for 
participation in the study when assessing the subject eligibility. 
x 
Study personnel will be directed to read and follow the IFU. 
4.3.1 Benefits 
 
ALLEVYN Gentle Border is a silicone gel adhesive hydrocellular foam dressing that provides 
optimal moist wound healing environment to promote the healing of moderately and highly exuding 
wounds. 
The silicone adhesive layer is gentle, even to fragile skin, and makes it easy to apply, reposition 
and remove. The dressing has an absorbent foam pad. A breathable top film helps prevent 
bacterial contamination and is showerproof however the dressing should not be immersed in 
water. 
4.3.2 Other Precautions 
 
This will be the second study with ALLEVYN Gentle Border and its new wound contact layer (WCL) 
to evaluate the use in clinical practice. There is currently no direct clinical evidence concerning 
the safety of ALLEVYN Gentle Border with the new wound contact layer. There are no other 
precautions than listed in section 4.3. 
 OBJECTIVE(S) 
The aim of this multi-centre post-market clinical follow-up study is to gather clinical, health 
economic and safety data on the use of ALLEVYN Gentle Border with new wound contact layer 
(WCL) in the treatment of chronic wounds in the frame of post-market surveillance for this medical 
device. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 21 of 90 
 
 
 
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 
5.1 
PRIMARY OBJECTIVE 
To demonstrate clinical performance of ALLEVYN Gentle Border as measured by reduction in the 
size of the wound area (cm2) over a 4 week treatment period in patients with chronic and acute; 
full-thickness, partial thickness or shallow granulating, exuding wounds including pressure ulcers, 
leg ulcers, diabetic foot ulcers and dehisced surgical wounds. 
 
5.2 
SECONDARY OBJECTIVE(S) 
To generate safety and performance related data of ALLEVYN Gentle Border in patients with 
chronic and acute wounds. 
5.3 
CLAIMS 
This will be the second study with the new wound contact layer (WCL) to evaluate the entire 
performance of ALLEVYN Gentle Border in clinical practice. Clinical performance and safety data 
on AGB will support to extend the current evidence for ALLEVYN Gentle Border.  
 INVESTIGATIONAL PRODUCT 
ALLEVYN Gentle Border dressings are composite dressings, which are comprised of three layers 
as shown in Figure 1. The foam thickness of the middle layer for ALLEVYN Gentle Border is 4 mm 
thick.  
 
 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 22 of 90 
 
 
 
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 pink, high MVP, polyurethane adhesive 
pattern spread film, makes up the top layer. This layer 
is a dynamic breathable top film, allowing for faster 
fluid removal and aids in the prevention of fluid and 
bacterial strikethrough 
A 4-6mm white polyurethane foam absorbent 
layer (non-patient contacting) makes up the middle 
layer. 
A perforated, wound contact layer coated with a 
silicone adhesive is used in the bottom layer, which 
allows for the dressing to be easily applied and 
removed without losing its adhesive properties. 
Figure 1: Composite structure of all ALLEVYN Gentle Border Dressings 
Finished products are fitted with a release handle on the lower wound contact layer, which protects 
the adhesive during storage and transport, and which is removed prior to application of the device. 
The individual dressings are then packaged into 4-sided sealed, peelable pouches before 
cartoning. The final devices are sterilised by ethylene oxide sterilisation. 
6.1 
IDENTIFICATION  
6.1.1 Investigational Product 
ALLEVYN Gentle Border dressings are intended for external use only. They will be applied to the 
skin, over a wound, at a variety of anatomical sites. 
ALLEVYN Gentle Border dressings have been designed in different sizes and shapes.  
x 
ALLEVYN Gentle Border Square 
x 
ALLEVYN Gentle Border Rectangle 
x 
ALLEVYN Gentle Border Multisite 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 23 of 90 
 
 
 
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 
x 
ALLEVYN Gentle Border Sacrum 
x 
ALLEVYN Gentle Border Heel 
 
The regular shaped ALLEVYN Gentle Border dressing can be left in place for up to seven days, 
depending on the condition of the wound and the surrounding skin or until exudate is visible and 
approaches to within 0.5cm of the edge of the dressing pad, whichever is sooner. 
Intended Use 
ALLEVYN Gentle Border Dressings are indicated for the use in: 
x 
Wound management of chronic and acute; full-thickness, partial thickness or shallow 
granulating, exuding wounds such as: 
o Pressure ulcers 
o Leg Ulcers 
o Diabetic Foot Ulcers 
o First & Second Degree Burns 
o Donor Sites 
o Fungating ulcers 
o Surgical Wounds 
o Skin Tears 
x 
Pressure ulcer prevention on intact skin, including pressure ulcers caused by medical devices, 
as part of a pressure ulcer prevention protocol. 
Can be used in conjunction with INTRASITE Gel for necrotic or sloughy wounds. 
 
Manufacturer and available sizes 
ALLEVYN Gentle Border is manufactured by Smith & Nephew Medical Limited, 101 Hessle 
Road, Hull, HU32 BN, England. 
 
 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 24 of 90 
 
 
 
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 
 
 
Sizes and shapes used in this study 
 
The study centers will be provided with ALLEVYN Gentle Border dressings based on the center 
specific needs. Figure 2 and table 2 show the different sizes and shapes available in the ALLEVYN 
Gentle Border range.  
   
  
  
  
 
 
Figure 2: ALLEVYN Gentle Border Shapes 
 
Table 2: ALLEVYN Gentle Border Size and Ordering Information 
 
S&N code 
Dressing size 
Carton 
66800269 
7.5cm x 7.5cm 
10 
66800270 
10cm x 10cm 
10 
66800900 
10cm x 20cm 
10 
66800264 
10cm x 25cm 
10 
66800265 
10cm x 30cm 
10 
66800272 
12.5cm x 12.5cm 
10 
66800506 (Heel) 
23cm x 23.2cm 
  5 
66800959 (Multisite) 
17.1cm x 17.9cm 
10 
66800897 (Sacrum) 
16.8cm x 17.1cm 
  6 
 
AGB is designed to be worn for up to seven days. Subjects will have their dressings changed 
according to individual clinical need. The total duration of treatment with AGB will also depend on 
factors such as wound healing, topical wound treatments, or suitability of continued treatment with 
AGB. If the wound does not heal, the maximum study treatment period will be 4 weeks. In these 
Square 
Rectangular 
Multisite 
Sacrum 
Heel 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 25 of 90 
 
 
 
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 treatment weeks the dressing will be changed at minimum every week (each 7th day). Depending 
on the healing process, the number of AGB dressings used by each subject will differ. 
6.1.2 Comparator Treatment 
There is no comparator treatment in this study. 
6.1.3 Ancillary Product 
INTRASITE GEL WILL BE PROVIDED ON REQUEST FOR NECROTIC OR SLOUGHY WOUNDS. 
6.1.4 Medical Personnel Training 
Study centre personnel with responsibilities for the medical care of subjects and/or application of 
ALLEVYN Gentle Border will be trained by the Monitor or Study Manager on the use and 
application of AGB prior to enrolling subjects into the study. The training of the investigator will 
only occur following completion of the clinical trial agreement. Study training of involved medical 
personnel will involve a presentation on the correct application and use of AGB, including 
frequency of dressing change.  
6.1.5 Application of ALLEVYN Gentle Border 
Application of the product will follow the directions from the product IFU. 
1. Cleanse the wound in accordance with normal procedures. 
2. Select the appropriate dressing size. 
3. Prepare and clean the skin surrounding the wound area by removing excess moisture. Any 
excess hair should be clipped to ensure close approximation to the wound. 
4. Start to remove the protector material from the dressing and anchor the adhesive side of the 
dressing to the skin. (Image A) 
5. Smooth the dressing over the wound removing the remaining protector material and ensure that 
the dressing is adhered all around the wound. (Image B) 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 26 of 90 
 
 
 
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. ALLEVYN Gentle Border can be cut and an aseptic technique should be used with cutting the 
dressing. Ensure any exposed foam areas are covered with an appropriate film dressing taking 
care not to cover the entire dressing. 
 
Figure 3: AGB Application Instruction
6.1.6 Dressing Change 
The investigator will be instructed to follow directions given in the product IFU when changing the 
study device. 
During the early stages of wound management, ALLEVYN Gentle Border dressings should be 
inspected frequently. Dressings can be left in place for up to 7 days depending on the condition 
of the wound and the surrounding skin or until exudate is visible and approaches to within 0.5cm 
of the edge of the dressing pad, whichever is sooner. 
 
No need to change 
 
 
No need to change 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 27 of 90 
 
 
 
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 
 
 
Exudate within 0.5cm of the edge of the pad requires changing 
Figure 4: Stages before dressing change 
 
6.2 
PACKAGING AND LABELING 
6.2.1 Labeling of Investigational Product 
ALLEVYN Gentle Border is a marketed product. However, Smith & Nephew will supply each site 
with ALLEVYN Gentle Border for use during the study. All test articles will be supplied in standard 
commercial packaging, clearly showing the batch number and expiry date. A label with the 
following information will be affixed to the AGB packaging without obscuring any regulatory text:  
• 
T.J. Smith and Nephew Limited, England 
• 
Study Number 
• 
Store in a dry place below 25° C 
• 
Keep away from sunlight  
• 
For Investigational Use Only 
6.2.2 Storage of ALLEVYN Gentle Border 
ALLEVYN Gentle Border should be stored in a dry place below 25°C, and away from sunlight. 
6.3 
PRODUCT ACCOUNTABILITY PROCEDURES  
The Sponsor will keep a record of all AGB dressings supplied to each site. Confirmation of receipt 
by the Investigator will also be retained. Overall accountability for the accuracy of the used devices 
is the responsibility of the Investigator or designated individual. All cartons will be clearly identified 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 28 of 90 
 
 
 
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 
per the labeling in Section 6.2.1. The Study Monitor will ensure that the procedures and records 
are in place to monitor the appropriate use of all test articles. 
In addition, any ancillary products (INTRASITE) supplied to the site by the Sponsor will require 
also a confirmation of receipt by the Investigator and an overall accountability.  
Used dressings will be appropriately destroyed per local requirements for clinical waste by the site 
staff without verification by the study monitor. 
 
 SUBJECT ENROLLMENT AND WITHDRAWAL 
7.1 
SUBJECT POPULATION 
Forty adult subjects with moderate to highly exuding wounds that require a dressing will be 
recruited. Only subjects with acute wounds or chronic wounds which are present > 6 weeks will 
be enrolled. Chronic wounds will include pressure ulcers, leg ulcers, diabetic foot ulcers. Acute 
wounds will include dehisced surgical or traumatic wounds. In order to ensure a balanced 
distribution on chronic and acute indications, at least 10 subjects with chronic wounds and at least 
10 subjects with acute wounds will be enrolled. 
7.2 
INCLUSION CRITERIA 
Subjects will be considered qualified for enrollment if they meet the following criteria: 
1. Signed written informed consent. 
2. 18 years of age or older. 
3. Willing and able to make all required study visits. 
4. Able to follow instructions and deemed capable of completing the CWIS 
questionnaire, Patient Assessment Scale and Pain Scale. 
5. Presence of a moderately to highly exuding wound of at least 3cm2 in size. 
6. Presence of a chronic wound of at least 6 weeks duration at the point of 
enrollment; full-thickness, partial thickness or shallow granulating wounds. 
7. Chronic wounds include: 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 29 of 90 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
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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 
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 pressure ulcers or 
o leg ulcers or 
o diabetic foot ulcers.  
or 
Presence of an acute wound at the point of enrolment; full-thickness, partial 
thickness or shallow granulating wounds. 
8. Acute wounds include: 
o dehisced surgical or 
o traumatic wounds. 
9. The patient has a wound size which can be treated with the available sizes and 
shapes of ALLEVYN Gentle Border. Cutting of the dressing is allowed, if needed. 
ALLEVYN Gentle Border can be cut and an aseptic technique should be used with 
cutting the dressing. Ensure any exposed foam areas are covered with an 
appropriate film dressing taking care not to cover the entire dressing. 
 
 
7.3 
EXCLUSION CRITERIA 
Any one (1) of the following criteria will disqualify a potential subject from participation in the 
study: 
1.  Subjects with confirmed or suspected clinically infected reference wound. 
2.  Reference wound undergoing treatment with compression therapy. 
3.  Contraindications or hypersensitivity to the use of the ALLEVYN Gentle Border. 
4.  Participation in the treatment period of another clinical trial within 30 days of Visit 1 
or planned participation overlapping with this study. 
5.  Subjects with skin features (e.g. tattoos, skin color, pre-existing scarring) which, in 
the opinion of the Investigator, could interfere with the study assessments. 
6.  Subjects who have participated previously in this clinical trial. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
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Version: 3.0 
Date: 21 JUN 2019 
Page: Page 30 of 90 
 
 
 
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 
7.  Subjects with a history of poor compliance with medical treatment. 
8.  Subjects with a medical or physical condition that, in the opinion of the 
Investigator, would preclude safe subject participation in the study. 
7.4 
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.  
7.5 
INFORMED CONSENT 
Before conducting any study procedures or examinations, the purpose and nature of the study 
should be explained to the subject. The subject, will then read, sign, and personally date the 
EC-approved informed consent document(s). Additionally, the individual who obtains consent from 
the subject will sign and date the informed consent document. A copy of the signed informed 
consent document will be provided to the subject, a copy will be placed in the subject’s medical 
record, with the original filed in the Investigator Site File (ISF). 
7.6 
ENROLMENT 
The point of enrolment into the study is when the subject has signed and dated the informed 
consent document and met all the eligibility criteria. 
The anticipated enrolment period for 40 subjects is thirteen (13) months. Once the subject is 
enrolled a subject ID number will be assigned as a unique study identifier. 
7.7 
LOST TO FOLLOW-UP 
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 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
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Version: 3.0 
Date: 21 JUN 2019 
Page: Page 31 of 90 
 
 
 
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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 
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. 
7.8 
WITHDRAWAL 
7.8.1 Withdrawal from Treatment 
If a subject is withdrawn from study treatment the Treatment Discontinuation Case Report Form 
(CRF) needs to be filled out. However, the subjects will be followed up to the end of the study for 
safety assessments until day 28 (± 3 days).  
Subjects may be withdrawn early from study treatment based on the decision of the investigator. 
This might include but is not limited to the following reasons: 
x 
Closure of the reference wound 
x 
Worsening condition of reference wound 
x 
If the subject misses two (2) consecutive dressing changes/study visits, interrupting treatment 
for longer than seven (7) days 
x 
A change in treatment that is clinically warranted 
x 
An adverse event (AE) 
x 
Concurrent illness 
x 
Adverse device effects (ADE) 
x 
Non-compliance (e.g. did not follow instructions) 
x 
Lost to follow-up (LTFU) 
x 
Any other significant reason identified by the Investigator 
 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
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Version: 3.0 
Date: 21 JUN 2019 
Page: Page 32 of 90 
 
 
 
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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 
Any subject that does not meet the minimum reference wound size requirement following wound 
size tracing at Visit 1 will be withdrawn. Subjects withdrawn from the study for this reason alone 
shall be replaced by enrolment of a new study subject. A new subject number will be assigned. 
7.8.2 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. 
7.8.3 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 
8.1 
STUDY DESIGN 
This is a non-randomized, open label study in up to 8 study centres at maximum, conducted in up 
to 3 countries in Europe. The sample size is 40 subjects. There is no comparator group, however, 
subjects will be consecutively enrolled into 2 wound groups: A minimum of 10 subjects with acute 
wounds and a minimum of 10 subjects with chronic wounds. 
Participation in the study will last 4 weeks (28±3 days) for each subject. All subjects will receive 
ALLEVYN Gentle Border as the study device, there is no control group. Subjects will be required 
to make at least one visit per week to the study center. 
In total, 5 study visits are planned for each subject (day 0, day 7, day 14, day 21, day 28). The 
primary clinical endpoint (reduction of wound size) will be assessed at each study visit by using a 
specific camera. This camera will make a photograph of the wound in a standardized manner and 
will calculate the wound length, wound width and the depth of the wound automatically.  

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 33 of 90 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
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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 
8.1.1 Treatment Allocation 
This study is not randomized.  
8.1.2 Blinding 
This study is an open label post-market clinical follow-up study. 
8.2 
STUDY ENDPOINTS 
8.2.1 Primary Endpoint 
The absolute reduction in wound area from baseline to end of study visit. 
8.2.2 Secondary Endpoints  
x 
Absolute reduction in area from baseline to days 7(+/-3), 14 (+/-3), 21 (+/-3) 
x 
Absolute reduction in depth and volume from baseline to visits 2, 3, 4 and end of study visit 
x 
Percentage reduction in area, depth and volume from baseline visit to visits 2, 3, 4 and end of 
study visit 
x 
Exudate management (fluid handling ability including leakage and percentage strikethrough)  
x 
Exudate type, amount and viscosity 
x 
Odour control – during wear and during dressing change  
x 
Dressing change frequency 
x 
Condition of surrounding skin 
x 
Signs of clinical infection 
x 
Healing of reference wound 
x 
Dressing wear time 
x 
Dressing retention, presence of bunching up and percentage dressing lift 
x 
Comfort during wear 
x 
Showerproof qualities 
x 
Pain on application, during treatment and on dressing removal 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
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Version: 3.0 
Date: 21 JUN 2019 
Page: Page 34 of 90 
 
 
 
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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 
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 
 
Patient Reported Outcome (PRO): 
 
x 
To assess the change from baseline in subject reported outcomes using the Cardiff Wound 
Impact Schedule (CWIS) 
 
Safety Performance: 
 
x 
All Adverse Events and Device Deficiencies 
 
8.2.3 Other Endpoints 
Not applicable. 
8.3 
METHODS USED TO MINIMIZE BIAS AND MAXIMIZE VALIDITY 
The study will be conducted across multiple centres and subjects will be enrolled by wound type 
to safeguard against major imbalances in clinical characteristics at baseline and aid comparability 
between the wound groups.  
 STUDY PROCEDURES 
9.1 
VISITS AND EXAMINATIONS  
9.1.1 Summary 
All subjects receive the ALLEVYN Gentle Border study device at visit 1 (Baseline, day 0). In total, 
all subjects need to perform 5 key study visits between week 1 and week 4, as shown in table 1. 
The visit schedule is based on the 7 days of maximum dressing wear time of ALLEVYN Gentle 
Border. The key visit date is counted from Baseline (day 0) and usually occurs on the same 
weekday in the following week. If a dressing change is required between the key visits the subject 
should come to an interim on-site visit (Routine Dressing Change Visit). A routine dressing change 
assessment will then be performed and documented in the Case Report Form. Then the subject 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 35 of 90 
 
 
 
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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 
continues with the next study key visit, counted from Baseline. If a subject is withdrawn from AGB 
treatment prior to key visit 5, this subject is still regarded as an active study participant. He/she 
should continue to come to the study key visit to follow-up with patients’ safety up to visit 5. 
 
9.1.2 Study Visit 1 - Initial Visit (Baseline Visit, day 0) 
The following assessment will be performed at Visit 1. 
1. 
Obtain written informed consent from the subject as detailed in Section 7.5. 
----- Do not proceed until consent has been obtained ----- 
2. 
Screen the subject for protocol inclusion/exclusion criteria and identify the study wound 
as the “reference wound” (if more chronic wounds are present per subject). 
3. 
Assign the subject to a study number. 
4. 
Provide the subject with the pages of CWIS and Patient Pain Scale, and allow sufficient 
time to complete it. 
5. 
Classify the wound type and perform wound assessment according to the Bates-Jensen 
Wound Assessment Tool (BWAT), as outlined in chapter 9.2.4. 
6. 
Photograph the wound with the delivered digital camera (Silhouette) and make sure 
that the image is assigned to the correct patient. 
7. 
Apply ALLEVYN Gentle Border dressing on the wound. 
8. 
Record details of the size and order number of ALLEVYN Gentle Border (including 
dressing cut, if performed). ALLEVYN Gentle Border can be cut and an aseptic technique 
should be used with cutting the dressing. Ensure any exposed foam areas are covered with an 
appropriate film dressing taking care not to cover the entire dressing. 
9. 
Assess the ease of applying the dressing, including remains in place and repositioning 
(if applicable). 
10. 
Instruct the subject to carefully follow the standard care instructions until the next 
dressing change and provide information concerning arrangements for future study 
visits. Subjects should return to the study center for the next study visit in 7 days (± 3), 
or earlier if a dressing change is required. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 36 of 90 
 
 
 
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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. 
Record the total time that the subject spent at the visit (start to finish of wound care 
procedures). 
 
9.1.3 Study Visit 2 (day 7, ±3), Visit 3 (day 14, ±3), Visit 4 (day 21, ±3) 
Visits 2 - 4 will be performed as on-site visits, so the subjects need to be present at each key study 
time point. These visits should take place every seventh (7) day. In case a dressing change is 
required before day 7, the instructions for a Routine Dressing Change Visit need to be followed 
(chapter 9.1.4). 
Subjects who are already withdrawn from treatment and no longer require a dressing change shall 
be followed up on the study visits to collect safety information. 
 
1. 
Question subjects regarding any changes in health or concomitant treatment. 
2. 
Hand out the CWIS, Patient Assessment Scale and Pain Scale to the subject and allow 
sufficient time to complete it.  
3. 
Photograph the dressing in situ prior to removal with the delivered digital camera. 
4. 
Remove the old dressing and inspect the wound. Complete a wound assessment 
according to BWAT (see Section 9.2.4). 
5.  
Assess the reason for dressing change, assess the ease of dressing removal and 
dressing leakage. 
6. 
Record any debridement and the method of debridement, and take a photograph of 
the wound immediately prior to and following debridement.  
Note: Photographs are not necessary if the subject was withdrawn from treatment at a 
previous visit. 
7.  
Redress the wound, if clinically indicated. 
8. 
Record details of all dressings used (e.g. brand, size, etc.) as well as any treatment 
applied underneath the dressing.  

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
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Version: 3.0 
Date: 21 JUN 2019 
Page: Page 37 of 90 
 
 
 
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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. 
Assess the ease of applying the new dressing, including remains in place and 
repositioning (if applicable). 
10. 
Instruct the subject to carefully follow the ulcer care instructions until the next dressing 
change and provide information concerning arrangements for future study visits. 
11. 
Record the total time that the subject spent at the visit (start to finish of ulcer care 
procedures). 
12. 
If any AE or DevD are observed or reported after application of study product, they must 
be reported as instructed in Section 12 (Adverse Events and Device Deficiencies). 
 
9.1.4 Routine Dressing Change Visit (between key study visits, if required) 
As ALLEVYN Gentle Border has a maximum recommended wear time of 7 days, routine dressing 
changes might occur between scheduled study visits. Dressings should not be given to study 
subjects; the dressing should only be changed by the investigator or delegated person. 
 
If a subject requires dressing change in between a study visit, the following assessments will be 
performed.  
 
1. 
Question subjects regarding any changes in health or concomitant treatment. 
2. 
Ask the subject to assess the comfort of wearing the dressing since the last visit. 
3. 
Photograph the dressing in situ prior to removal with the delivered digital camera. 
4. 
Remove the old dressing, inspect the wound and complete wound assessment 
according to BWAT (see Section 9.2.4). 
5.  
Assess the reason for dressing change, assess the ease of dressing removal and 
dressing leakage. 
6.  
Record any debridement and the method of debridement, and take a photograph of 
the wound immediately prior to and following debridement.  
7. 
Assess the level of pain experienced by the subject when the dressing is removed. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
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Version: 3.0 
Date: 21 JUN 2019 
Page: Page 38 of 90 
 
 
 
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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 
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.  
Redress the wound, if clinically indicated. 
9. 
Record details of all dressings used (e.g. brand, size, etc.) as well as any treatment 
applied underneath the dressing.  
10. 
If any adverse events or device deficiencies are observed or reported, they must be 
recorded as instructed in Safety Section 12.  
11. 
Redress the wound with ALLEVYN Gentle Border. 
12. 
Record details of the new ALLEVYN Gentle Border dressing. 
 
9.1.5 End of Study Visit (day 28, ±3) 
The End of Study Visit will be performed as an on-site visit. This should coincide with the normal 
timing of dressing changes, i.e. seven (7) days.  
 
1. 
Question subjects regarding any changes in health or concomitant treatment.  
2. 
Hand out the CWIS, Patient Assessment Scale and Pain Scale to the subject and 
allow sufficient time to complete it. 
3. 
Photograph the dressing in situ prior to removal with the delivered digital camera. 
4. 
Remove the old dressing, inspect the wound and complete wound assessment 
according to BWAT (see Section 9.2.4). 
Note: A full wound assessment is not necessary if the subject has already been 
withdrawn from treatment. 
5. 
Assess the reason for dressing change, assess the ease of dressing removal and 
dressing leakage. 
6. 
Record any debridement and the method of debridement, and take a photograph of 
the wound immediately prior to and following debridement. 
7. 
Fill out the Study Completion CRF.  

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
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Date: 21 JUN 2019 
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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 
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. 
Record the total time that the subject spent at the visit (start to finish of wound care 
procedures). 
9. 
If any AE or DD are observed or reported, they must be recorded as instructed in 
Safety Section 12.  
 
9.1.6 Unscheduled Visits  
Visits to the research site for other reasons than dressing changes may be captured as an 
Unscheduled Visit at the discretion of the Investigator with all information recorded in the source 
documents and on the Unscheduled Visit CRF. 
9.1.7 Concomitant Medications and Therapies 
A concomitant treatment is any drug, substance or device administered at any time from enrolment 
into the study through the last study visit.  
9.1.7.1 
Concomitant Medications  
9.1.7.1.1 Excluded Concomitant Medications 
x 
Oxidizing agents such as hypochlorite solutions (e.g. EUSOL) or hydrogen peroxide in 
conjunction with AGB, as these can reduce the absorbency of the dressing. 
9.1.7.1.2 Recording Concomitant Medications in the CRF 
Concomitant medications meeting the following criteria will be recorded on the CRF: 
x 
All current and past reference wound medication. 
x 
Concomitant medication used to treat the reference wound and the peri-wound area (such as 
treatment for erythema, irritation, itching), together with the indication for the medication. 
x 
Concomitant medications used to treat all Adverse Events (AE), Serious Adverse Events 
(SAE), ADE, Serious Adverse Device Effects (SADE) and Unanticipated Serious Adverse 
Device Effects (USADE).  

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
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Version: 3.0 
Date: 21 JUN 2019 
Page: Page 40 of 90 
 
 
 
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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 
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 
9.1.7.2 
Concomitant Therapies 
9.1.7.2.1 Therapies Prohibited During the Study 
x 
Negative pressure wound therapy during the study (e.g. PICO) 
9.1.7.2.2 Recording Concomitant Therapies in the CRF 
Concomitant therapies meeting the following criteria will be recorded on the CRF: 
x 
All current and past reference wound therapies. 
x 
Concomitant therapies used to treat the reference wound and the peri-wound area, together 
with the indication for the therapy. 
x 
Concomitant medications used to treat all Serious Adverse Events (SAE), ADE, Serious 
Adverse Device Effects (SADE) and Unanticipated Serious Adverse Device Effects (USADE). 
Adverse device effects related to administration of these treatments must be documented in 
the appropriate CRF.  
9.1.8 Discontinued Subjects 
Discontinued subjects are those who voluntarily discontinue participation in the study, who are 
withdrawn from the study for reasons of safety or non-compliance, or who are withdrawn from the 
study for failure to complete the patient scores at Visit 1. Where possible, the Treatment 
Discontinuation CRF should be completed for all subjects who discontinue the study early. When 
consent is withdrawn, the date of and reason for discontinuation should be captured. 
Subjects may be withdrawn from the study at any time if, in the opinion of the Investigator, their 
continued participation in the study poses a risk to the subject, as outlined in section 7.8.1.  
If appropriate, the Investigator will advise the subject of subsequent therapy and/or procedures 
necessary for their medical condition, which will consist of standard care. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
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Date: 21 JUN 2019 
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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 
9.1.9 Subject Pregnancy 
Women of child-bearing potential are not 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 a decision will be made regarding the continuation in the study of the 
pregnant woman. Pregnancy is not reportable as 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. 
9.2 
STUDY METHODS AND MEASUREMENTS 
9.2.1 Pressure Ulcer Classification 
Pressure ulcers should be classified according to the European Pressure Ulcer Advisory Panel 
2017 (3). 
Stage I: Non-blanchable erythema 
Intact skin with non-blanchable redness of a localized area usually over a bony prominence. Darkly 
pigmented skin may not have visible blanching; its color may differ from the surrounding area. The 
area may be painful, firm, soft, warmer or cooler as compared to adjacent tissue. Category I may 
be difficult to detect in individuals with dark skin tones. May indicate “at risk” persons. 
 
Stage II: Partial-thickness 
Partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, 
without slough. May also present as an intact or open/ruptured serum-filled blister. Presents as a 
shiny or dry shallow ulcer without slough or bruising.* This Category/Stage should not be used to 
describe skin tears, tape burns, perineal dermatitis, maceration or excoriation. 
*Bruising indicates suspected deep tissue injury. 
 
Stage III: Full-thickness skin loss 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
Full thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscle are not 
exposed. Slough may be present but does not obscure the depth of tissue loss. May include 
undermining and tunneling. The depth of a Category/Stage III pressure ulcer varies by anatomical 
location. The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and 
Category/Stage III ulcers can be shallow. In contrast, areas of significant adiposity can develop 
extremely deep Category/Stage III pressure ulcers. Bone/tendon is not visible or directly palpable.  
 
Stage IV: Full thickness tissue loss 
Full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present 
on some parts of the wound bed. Often include undermining and tunneling. The depth of a 
Category/Stage IV pressure ulcer varies by anatomical location. The bridge of the nose, ear, 
occiput and malleolus do not have subcutaneous tissue and these ulcers can be shallow. 
Category/Stage IV ulcers can extend into muscle and/or supporting structures (e.g., fascia, tendon 
or joint capsule) making osteomyelitis possible. Exposed bone/tendon is visible or directly 
palpable. 
9.2.2 Diabetic Foot Ulcer (DFU) Classification  
Diabetic foot ulcers should be classified according to SINBAD assessment (5). The SINBAD score 
represents an ulcer classification system which can be used as a standard measure in 
international studies. The SINBAD score ranges from 0 to 6 and emphases 6 different elements 
for DFU classification. The higher the score the higher the grade of DFU. The SINBAD score will 
be assessed for each subject at baseline visit. 
Site 
 
0=Forefoot 
1=Midfoot and Hind Foot 
Ischemia 
0=Pedal blood flow intact 
1=Reduced pedal blood flow 
Neuropathy 
0=Sensation intact 
1=Sensation lost 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
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Date: 21 JUN 2019 
Page: Page 43 of 90 
 
 
 
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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 
Infection 
0=None (bacterial) 
1=Present  
Area 
 
0=Ulcer< 1cm² 
1=Ulcer> 1cm² 
Depth  
0=Ulcer confined to skin and subcutaneous tissue 
1=Ulcer reaching muscle, tendon or deeper 
9.2.3 Photographs and Wound Size Measurements 
The primary endpoint will be assessed by the wound photographs collected by the delivered digital 
camera (Silhouette) during each key study visit. This makes sure that photographs can be 
compared by using a standardized technique. The secondary endpoint information will be derived 
by the following investigator assessments and by patient questionnaires as listed in this section 
below. 
 
Photographs: 
Wound photographs will be done by the investigator or delegated personnel. 
Photographs will be taken for all subjects per visit instructions (see section 9.1) by using the 
delivered digital camera (Silhouette). The study centers will be trained on the use of the camera 
prior to start with patient enrolment.  
 
Wound Size Measurement: 
The wound size measurements will be performed directly from the wound photographs taken from 
the wound per each visit. A special digital camera (Silhouette, ARANZ) will be delivered to the 
study center. The camera will measure the lengths, the depth and the width of the wound 
automatically. The wound photographs and the resulting wound measures will be stored in a 
database. A training will be performed prior to start of the study and handling instructions will be 
provided. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
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Date: 21 JUN 2019 
Page: Page 44 of 90 
 
 
 
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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 
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 
9.2.4 Reference Wound Assessments with modified Bates-Jensen Wound Assessment 
Tool (BWAT) 
Wound assessments will be performed by the investigator at each study visit in alignment with the 
Bates-Jensen Wound Assessment Tool (4). The Bates-Jensen Wound Assessment Tool provides 
13 assessment parameters which will be scored in a defined measure (1). Each score items will 
be summarized into a total score. The higher the total score, the more severe the wound status. 
A source data sheet containing each listed score items will be provided to the study centers to 
document the BWAT on a primary source. The BWAT tool and the instructions can be found in 
Appendix 21.4. 
9.2.5 Patient Assessment Scale 
The patient assessment scale (PAS) is a questionnaire that will be filled out by the patient. 
During the AGB treatment phase, the subject will be asked to answer the following questions at 
each study visit. The PAS will be entered directly into the case report form and will serve as 
source data. 
1. How have you found your experience in terms of leakage? 
0=Unacceptable level of leakage 
10=No leakage 
 
2. How have you found your experience in terms of the feeling of moisture on your skin 
underneath the dressing 
0=Unacceptable feeling of moisture 
10=No feeling of moisture on the skin 
 
3. How have you found your experience in terms of odour? 
0=Unacceptable level of odour 
10=No odour 
 
4. How have you found your experience in terms of visible exudate? 
0=Unacceptable level of visible exudate 
10=No visible exudate 
 

 
Study Protocol—Device 
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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 
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. How protected did the dressing make your wound feel? 
0=Unacceptable level of protection 
10=Very protected 
6. How have you found your experience in terms of dressing comfort? 
0=Unacceptable level of comfort 
10=Very comfortable 
 
7. How have you found your experience in terms of being able to maintain a normal showering 
routine? (NA if patient does not have a normal showering routine) 
0=Unacceptable level of impact (unable to bathe) 
10=No negative impact 
9.2.6 Patient Pain Scale (PPS) 
During the AGB treatment phase, the patient will be asked to describe the level of pain during the 
application, during AGB treatment and on removal of the dressing on a scale from 0 (no pain) to 
10 (worst pain). The subject will be asked to draw a vertical line on this visual scale to indicate the 
value. The value will be rounded to a whole number and transmitted into the CRF by the 
investigator. The PPS will be entered directly into the case report form and will serve as source 
data. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
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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 
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 
  
9.2.7 Cardiff Wound Impact Questionnaire (CWIS) 
The CWIS is a Quality of Life Questionnaire. During the AGB treatment phase, the subject will be 
asked to fill out the CWIS at each study visit. The CWIS will be entered directly into the case report 
form and will serve as source data. 
The CWIS is a subjective, qualitative measure that covers four domains: physical functional status, 
symptoms and side effects, social functioning and psychological state. Each line item provides 5 
answers. Only one box should be ticked by the subject per line item. The 5-point Likert scale will 
be counted from 1 to 5 and each domain will be listed separately at the end of the study (6). 
1 = Not at all/Not Applicable, 2 = Slightly, 3 = Moderately, 4 = Quite a bit, and 5 = Very 
 
9.2.8 Dressing and Clinical Performance 
The following items on dressing and clinical performance will be assessed by the investigator at 
each study visit. 

 
Study Protocol—Device 
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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 
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 
x 
Healing of reference wound (yes/no) and signs of clinical infection. 
x 
Dressing comfort (wear comfort, showerproof qualities, odour control) 
x 
Dressing movement (reason for change, adherence to wound, dressing retention, dressing lift 
or bunching up) 
x 
Dressing performance (leakage, strikethrough, change frequency, wear time, fluid handling 
ability) 
x 
Exudate evaluation (type, amount, viscosity)  
x 
Pain evaluation (application, during treatment, removal) 
x 
Wound and surrounding skin evaluation 
 
9.2.9 Biological Samples 
This study does not require the collection of any biological samples. 
9.3 
QUALITY OF LIFE  
The CWIS is a Quality of Life Questionnaire. During the AGB treatment phase, the subject will be 
asked to fill out the CWIS at each key study visit.  
 
The Cardiff Wound Impact Schedule (CWIS) is a validated tool for assessing the health-related 
quality of life of people with venous leg ulcers and diabetic foot ulcers. It is a subjective, qualitative 
measure that covers three domains:  
x 
Physical symptoms and daily living (24 items, score range: 24-120) 
x 
Social life (14 items, score range: 14-70) 
x 
Well-being (7 items, score range: 7-35) 
 
Each question provides 5 answers and will be counted from 1 (not at all) to 5 (very). Only one box 
should be ticked by the subject per line item. (6). This instrument also includes two further single 
item ‘global’ scales for HRQoL and satisfaction with the quality of life.  

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
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Version: 3.0 
Date: 21 JUN 2019 
Page: Page 48 of 90 
 
 
 
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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 
 STATISTICAL DESIGN 
The following is a brief description of the analyses to be described in this plan. If there are any 
changes from the analysis described below it will be detailed in the SAP and the Clinical Study 
Report (CSR). Any changes/additions to the analysis described in the SAP will also be detailed in 
the CSR. 
10.1 
GENERAL 
Smith & Nephew’s Global Biostatistics group will conduct the statistical analysis for this study. 
Unless otherwise stated, all significance tests and hypothesis testing will be two-sided, performed 
at the 5% significance level. Resulting p-values will be quoted and 95% two-sided confidence 
intervals will be generated where appropriate.  
Where data summaries are specified, categorical and ordinal variables will be summarized with 
frequencies and percentages. Continuous variables will be summarized with the following 
summary statistics: number of observations, mean, median, standard deviation, minimum and 
maximum values. All analyses will be performed in SAS 9.4 (or later).  
The handling of missing data will be detailed in the SAP. 
10.2 
ANALYSIS POPULATIONS 
The following analysis populations will be used for this study: 
x 
Safety Population (SAF): Including all subjects who enroll in the study and receive the 
study treatment. This population will be used for analysis of safety. 
x 
Modified Intention to Treat population (mITT): following Intention to Treat principle 
including all subjects who are enrolled into the study and complete at least one post-
baseline assessment. This population will be used for the primary analysis of the primary 
and secondary endpoints. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
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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 
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 
x 
Per-Protocol Population (PP): including all subjects in the mITT, who have no significant 
protocol deviations and who meet the inclusion/exclusion criteria. This population will be 
used for a secondary analysis of the primary and secondary endpoints. 
10.3 
BASELINE DATA 
Baseline data to be summarised includes: demographics, relevant medical history, wound type, 
wound location and duration of reference wound. Baseline data for all primary and secondary 
endpoints (clinical performance, dressing performance and patient reported outcomes) will be 
summarised along with the rest of the visits for each particular endpoint. 
10.4 
EFFICACY ANALYSIS 
10.4.1 Analysis of Primary Endpoint 
The primary endpoint for this study is the absolute reduction in wound area from baseline to end 
of study. 
The reference wound area will be summarised at each dressing change assessment and study 
visit. The absolute reduction in the reference wound area from baseline to each post-baseline 
study visit will also be summarised. 
The absolute reduction in area will be analysed as the dependent variable in a repeated measures 
ANCOVA model. As a minimum the models will contain a term for visit and the following terms will 
be added to the model using a stepwise selection procedure with an F-value to attain a 
significance level of 0.1: centre, wound type, BMI and baseline area. The estimate LSMean 
reduction in area from baseline to all study visits will be presented with the associated 95% 
confidence intervals, with the estimate for the end of study visit (day 28±3) being used for analysis 
of the primary endpoint. 
If the assumptions of ANCOVA are not met then a non-parametric analysis will be considered. 
The primary analysis analysis of this endpoint is to be carried out using the mITT population. The 
same analysis will be carried out on the PP population as a secondary analysis. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
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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 
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 
10.4.2 Analysis of Secondary Endpoints 
All secondary endpoints will be analysed using the mITT population as the primary analysis. 
Wound Measurements 
The reference wound volume and depth will be summarised at each dressing change assessment 
and study visit. The absolute reduction in the reference wound volume and depth from baseline 
to each visit will also be summarised. 
The same analysis as the above repeated ANCOVA model is planned to be used to analyse 
absolute reduction in volume and depth (separately) from baseline to all post-baseline study visits. 
As well as the summaries of absolute reduction, the percentage reduction in area, volume and 
depth will also be summarised from baseline to all post-baseline study visits. 
 
Cardiff Wound Impact Schedule (CWIS): 
The CWIS consists of three domains: Social Life (CWIS-SL), Wellbeing (CWIS-WB), Physical 
Symptoms and Daily Living (CWIS-PSDL). For each domain a score from 0-100 is derived with 
higher scores being better. 
Scores for each CWIS domain will be summarised at each study visit by wound type and overall. 
The increase in score from baseline to each study visit will also be summarised by wound type 
and overall. 
A repeated measures ANCOVA model will be fit separately for each CWIS domain. In each case 
the domain score will be used as the dependent variable and as a minimum the model will contain 
a term for visit. The following extra terms will be added to the model using a stepwise selection 
procedure with an F-value to attain a significance level of 0.1: centre, wound type, BMI and 
baseline domain score. The estimate LSMean increase in domain score from baseline to all study 
visits will be presented with the associated 95% confidence intervals. 
If the assumptions of ANCOVA are not met then a non-parametric analysis will be considered. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
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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 
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 and Dressing Performance 
 
Performance endpoints to be summarised at all study visits and routine dressing changes by 
wound type and overall include: 
x 
Reference wound healed (yes/no). 
x 
Comfort during wear. 
x 
Odour control – during wear and during dressing change. 
x 
Showerproof qualities. 
x 
Dressing retention, presence of bunching up and percentage dressing lift.  
x 
Pain on application, during treatment and on dressing removal. 
x 
Exudate type, amount and viscosity.  
x 
Exudate management (fluid handling ability including leakage and percentage strikethrough).  
x 
Dressing adherence to wound bed will be cross-tabulated by exudate level at previous 
dressing assessment. 
x 
Dressing wear time (days) should be summarised for both wear time per subject i.e. take the 
average wear time for each subject and summarise that and also for the wear time of all 
dressings used in the study. 
x 
Dressing change frequency will be summarised as the number of dressings per subject. 
x 
Condition of surrounding skin will be summarised at all study visits and routine dressing 
changes. Also the condition of surrounding skin at each post-baseline study visit will be cross 
tabulated with condition of surrounding skin at baseline. 
x 
Signs of clinical infection will be summarised at all study visits and routine dressing changes.  
10.5 
SAFETY ANALYSES 
All safety analyses and summaries will be conducted using the Safety Population. Unless 
otherwise stated. 
Extent of Exposure 
The duration of treatment will be summarized.  

 
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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 
Adverse Events 
Adverse events will be coded and grouped by system organ class using the Dictionary for Medical 
Drug Regulatory Activities (MedDRA). 
The number of subjects reporting: adverse events (AE), serious adverse events (SAE), adverse 
device effects (ADE), serious adverse device effects (SADE) and unanticipated serious adverse 
effects (USADE) will be summarized. In addition, AEs will be summarised by: severity; the 
relationship to the investigational device; outcome and duration of adverse events at trial 
discontinuation. 
Further safety summaries may be defined in the SAP. 
10.6 
INTERIM ANALYSES 
Not Applicable 
 SAMPLE SIZE JUSTIFICATION 
The sample size determination for this study was based on a previous study (CE/046/ALF) 
demonstrating an absolute mean reduction in wound area from baseline to 28 days of 3cm2 with 
a standard deviation of 5cm2, in a range of moderate to highly exuding wound types. In order to 
show a statistically significant reduction in the mean wound area for this study, it was calculated 
that 26 subjects would achieve 83% power.  
 
Unfortunately, several subjects were recruited into the current study with wounds smaller than 
3cm2, little to no exudate or chronic wounds of less than 6 weeks duration, meaning these wounds 
are not comparable to the previous study in terms of healing challenge. As a result, protocol 
modifications have been made to ensure a minimum wound size is included in the inclusion criteria 
as well as provide an opportunity to re-emphasise the challenging nature of wounds we are 
seeking to recruit with regards to level of exudate. With this in mind and accounting for the 10 
patients enrolled in the study under protocol V2.0 (as at 19 June 2019), it is recommended we 

 
Study Protocol—Device 
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Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
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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 
increase the total patient recruitment target to n = 35 patients to ensure we have captured a range 
of wounds of comparable healing challenge to the previous study.  
 
Using the same assumptions, it can be calculated that 35 subjects would provide 93% power to 
show a statistically significant reduction in the mean wound area from baseline to 28 days. 
Analysis for this study will be conducted separately for patients that comply with V3.0 of the 
protocol and therefore the study is over-powered to allow for greater than 80% power in the V3.0 
protocol population.  
 
Allowing for a 15% lost to follow up rate as used previously, 40 subjects will be recruited into this 
study.   
 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
12.1 
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 3: 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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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 between enrollment and treatment 
discontinuation associated with the use of an IP/Ancillary Product, whether or not considered 
causally related to that IP/Ancillary Product. 
AE is used both to refer to AE which are non-serious non-IP or procedure-related 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 that, in the opinion of the investigator, is 
related to the IP or the procedure.  
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 or UNLIKELY 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, PROBABLE, 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. 

 
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
12.1.3 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, in the view of either the Investigator or the Sponsor, it: 
x 
a) led to death, 
x 
b) led to serious deterioration in the health of the subject, that either resulted in 
o 
1) a life-threatening illness or injury, or 
o 
2) a permanent impairment of a body structure or a body function, or 
o 
3) in-patient or prolonged hospitalization, or 
o 
4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
x 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect 
Note: 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 analysis 
report.  
Note: An anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report. Summary of risk 
analysis report and thus anticipated SADEs is communicated through the IFU and in protocol 
section 4.3. 
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 

 
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Gentle Border 
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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 
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.  
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. 
12.2 
AE CODING DICTIONARY  
The latest version of MedDRA will be used to code AEs. 

 
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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 
12.3 
REPORTING PROCEDURES 
AE of any kind and DD will be recorded in the applicable CRF and source notes. The Investigator 
will evaluate all AE for relationship to the device and procedure, if applicable, seriousness, and 
severity. 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): 
x 
ADE and DD – without unreasonable delay 
x 
SAE, SADE and DD with potential to cause SADE – immediately (i.e. within 24 hours of the 
investigator being informed about the event) 
For ADE and DD, 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 IRB/IEC of adverse events according to the IRB/IEC requirements. 
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 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, ADE and 
SADE, unanticipated SADE, and DD. 

 
Study Protocol—Device 
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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 
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 5: Evaluation and Reporting of AE 
 
 

 
Study Protocol—Device 
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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 6: Evaluation and Reporting of DD 
 
12.4 
UNBLINDING OF INVESTIGATIONAL PRODUCT 
Not applicable. 
12.5 
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.  
12.5.1 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 

 
Study Protocol—Device 
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Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
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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 
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
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 study protocol and in 
the Clinical Trial Agreement provided by the Sponsor, and with Good Clinical Practice (GCP), and 
all applicable regulatory requirements as outlined in Appendix 21.9 of this protocol. 
 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. 
14.1 
CONTRACT RESEARCH ORGANIZATION  
The Sponsor has engaged Contract Research Organization (CRO) to assist in conducting this 
study. When appropriate, the CRO is referred in study documents as “Sponsor’s agent.” 

 
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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 
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 
14.2 
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. 
14.3 
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 EC approval.  
14.4 
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.  
14.5 
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 EC reporting requirements.  
 PROTOCOL AMENDMENTS 
Amendments should be made only in exceptional cases once the study has started. Protocol 
amendments must be approved by the protocol signatories prior to submission to the EC. Protocol 
amendments need to be approved by the EC and Regulatory Authority(ies), as applicable prior to 
implementation at the site. 

 
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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 
 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 2016; and ISO 14155:2011 Clinical investigation of medical devices – Good Clinical 
Practice. 
This clinical study will not commence until the required approval/favorable opinion from the EC or 
regulatory authority has been obtained. Any additional requirements imposed by the EC 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. ALLEVYN Gentle Border is a commercially available product and therefore should be 
available to subjects after their participation in this study. Subjects may participate for a maximum 
total duration of 28 (±3) days. 
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.  

 
Study Protocol—Device 
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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 
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 
 PUBLICATION POLICY 
19.1 
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. 
19.2 
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. 
 REFERENCES 
1. 
B. SCB-J. Tools to measure wound healing. Wound Care: A Collaborative Practice Manual 
Wolters Kluwer Health, Philadelphia. 2007:Chapter 6, p. 159. 
2. 
Callaghan R. Case series evaluation: the use of Allevyn Gentle Border Multisite on chronic 
wounds. Wounds UK. 2012;8(4). 
3. 
EPUAP. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. 2014:12-3. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
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Page: Page 64 of 90 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
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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. 
Harris C, Bates-Jensen B, Parslow N, Raizman R, Singh M, Ketchen R. Bates-Jensen wound 
assessment tool: pictorial guide validation project. J Wound Ostomy Continence Nurs. 
2010;37(3):253-9. 
5. 
Hurd T, Gregory L, Jones A, Brown S. A multi-centre in-market evaluation of ALLEVYN ◊ Gentle 
Border. Wounds UK. 2009;5(3):32-44 
6. 
P. I, ZG. A. Use of the SINBAD classification system and score in comparing outcome of foot 
ulcer management on three continents. Diabetes Care. 2008;May. 
7. 
Price P, Harding K. Cardiff Wound Impact Schedule: the development of a condition-specific 
questionnaire to assess health-related quality of life in patients with chronic wounds of the lower 
limb. Int Wound J. 2004;1(1):10-7. 
8. 
Grothier L. Gentle foam dressings: interim results of an evaluation of the Allevyn range. Br J Nurs. 
2009;18(11):S12, S4, S6 passim 
9. 
Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, et al. Human skin wounds: a major 
and snowballing threat to public health and the economy. Wound Repair Regen. 2009;17(6):763-
71. 
10. 
Smith&Nephew. Clinical Evaluation Report ALLEVYN Gentle Border. 2017. 
11. 
Smith&Nephew. Summary of Results CE/046/ALF. 2014. 
 
 
 

 
Study Protocol—Device 
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Study to Evaluate the Safety and Effectiveness of ALLEVYN 
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Page: Page 65 of 90 
 
 
 
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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 
 APPENDICES 
21.1 
PROTOCOL AMENDMENT  
21.1.1 General Purposes 
a. The following minimum wound size requirement to be added to the inclusion criteria: 
x 
Presence of a moderately to highly exuding wound of at least 3cm2 in size.  
b. The sample size and number of sites will be increased to ensure capturing a range of 
wounds of comparable healing challenge to a previous study.  
c. The French Ethics Committee reviewed the study and made the following request for 
changes on protocol. 
x 
To add bibliographic references of randomized studies evaluating the effectiveness of 
the medical device. 
d. To remove the Patient Assessment Scale, one of the patient reported outcome 
measurement tools, at Baseline visits. 
21.1.2 Rationale 
Regarding Purpose (a), to ensure the wound can be evaluated for up to 4 weeks a revision to the 
current inclusion criteria is required with the need for the wound area to be at least 3 cm2. The 
minimum wound size of 3cm2 has been determined based on wound progression observed in 
previous similar clinical wound healing studies. Including a minimum wound size will ensure that 
we are collecting pertinent data regarding dressing performance for both chronic and acute 
wounds over the entire 4-week treatment period.  
Regarding Purpose (b), the sample size determination for this study was based on a previous 
study demonstrating an absolute mean reduction in wound area of 3cm2 in a range of moderate 
to highly exuding wound types. Unfortunately several subjects were recruited into the current study 
with wounds smaller than 3cm2, little to no exudate or did not satisfy the inclusion criteria of being 
chronic wounds (pressure ulcers, leg ulcers or diabetic foot ulcers) of at least 6 weeks duration. 

 
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
As a result, this modification is going to ensure a minimum wound size is included in the inclusion 
criteria as well as provide an opportunity to re-emphasise the challenging nature of wounds aimed 
to be recruited with regards to the level of exudate. Increasing the total patient recruitment target 
to n= 40 subjects is aiming to ensure to capture a range of wounds of comparable healing 
challenge to the previous study. 
Regarding Purpose (c), additional references and explanations were added to address the request 
from the French Ethics Committee. 
Regarding Purpose (d), the questions in the Patient Assessment Scale are more applicable 
following the use of ALLEVYN Gentle Border dressing rather than before the treatment with 
ALLEVYN Gentle Border.  
21.1.3 Effect on Study Status 
The amendment does not have impacts on the conduct of the study.  
21.1.4 Details  
The changes listed in Section 21.1.1 are made across the protocol respectively as listed in 
details below. A reminder to the aseptic technique and dressing precaution was added to where 
cutting the dressing is allowed being mentioned, i.e. Sections 7.2 and 9.1.2. In Section 10.4.1 
Analysis of Primary Endpoint, the percentage reduction in wound area was mistakenly 
mentioned, it is corrected to absolute reduction in wound area, as percentage is covered as a 
secondary endpoint. Study team members are updated to reflect the change of Smith & Nephew 
personnel. The study schedule at Section 2 and 6 are updated to reflect the protocol design and 
information from the IFU accurately. It is clarified in Section 9 that the patient reported outcomes 
will be entered directly into the case report form and will serve as source data. The extra blank 
page was deleted after page 2. 

 
Study Protocol—Device 
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Study to Evaluate the Safety and Effectiveness of ALLEVYN 
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Date: 21 JUN 2019 
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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 
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 
 
Current Text 10/OCT/2018 
Version 2.0 
Revised Text 19/JUN/2019 Version 
3.0 
 
2. Synopsis 
 
 
 
 
Sample Size: 30 Subjects 
 
Number of Study Sites:  
2-6 study sites 
 
Statistical Rationale:  
It is assumed that the actual 
reduction in the mean wound area 
from baseline to 28 days is 3cm2 
with a standard deviation of 5cm2. 
Assuming this data holds true it 
can be calculated that 26 subjects 
would provide 83% power to show 
a statistically significant reduction 
in the mean wound area from 
baseline to 28 days. Allowing for a 
15% lost to follow up rate, 30 
subjects will be recruited into this 
study. 
 
 
 
 
 
- 
 
 
 
- 
40 subjects 
 
 
Up to 8 study sites 
 
 
It is assumed that the actual 
reduction in the mean wound area 
from baseline to 28 days is 3cm2 with 
a standard deviation of 5cm2. 
Assuming this data holds true it can 
be calculated that 26 subjects would 
provide 83% power to show a 
statistically significant reduction in the 
mean wound area from baseline to 28 
days. Accounting for the protocol 
modifications outlined in Section 21, it 
is recommended to increase the total 
patient recruitment target to 35 
subjects, providing 93% power. 
Allowing for a 15% lost to follow up 
rate, 40 subjects will be recruited into 
this study.  
Added to the Inclusion Criteria: 5. 
Presence of a moderately to highly 
exuding wound of at least 3cm2 in size. 
 
Added to Point 7 of the Inclusion 
Criteria: ALLEVYN Gentle Border can 
be cut and an aseptic technique 
should be used with cutting the 
dressing. Ensure any exposed foam 
areas are covered with an 
appropriate film dressing taking care 
not to cover the entire dressing. 
 
The Study Schedule table is updated 
to accurately reflect the study events 

 
Study Protocol—Device 
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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 
as shown in the later part of Section 
21.1.4. Details. 
4. INTRODUCTION 30 subjects 
40 subjects 
4.1 Literature 
Summary 
- 
Added a second paragraph: 
In addition, several clinical studies 
utilising AGB have been identified 
demonstrating evidence of the safety 
and performance of AGB in wound 
management. A previous comparative 
clinical study evaluating the use of 
AGB compared to a competitor 
dressing demonstrated the safe and 
effective use in 21 patients with 
chronic and acute wounds. No major 
safety issues were highlighted with 
either dressing and clinicians were 
satisfied with exudate handling in all 
AGB dressing changes. (10). A study 
by Grothier et al. (2009) showed that 
AGB 
was 
rated 
highly 
by 
the 
investigating clinicians, with an 87% 
level of acceptance for the range of 
clinical 
indications 
treated. 
Satisfaction 
with 
the 
dressing’s 
exudate management was reported in 
86% of dressing changes. Another 
case series, including 153 patients, 
demonstrated that the AGB dressing 
was effective in improving wound 
outcomes, 
in 
particular 
reducing 
wound area, depth and level of 
exudate in routine clinical practice. 
Significant reduction in wound area 
and depth by the final assessment was 
observed (p<0.001; Hurd et al, 2009). 
Both of these studies, alongside many 
others 
(including 
comparative 
studies), have demonstrated the safe 
and effective use of ALLEVYN Gentle 
Border in wound management (10). 

 
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TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
6.1.1. 
Investigational 
Product 
The regular shaped ALLEVYN 
Gentle Border dressing can be left 
in place for up to seven days, 
depending on the condition of the 
wound and the surrounding skin 
or until exudate is visible and 
approaches to within 1.5cm of the 
edge of the dressing pad, 
whichever is sooner. 
The regular shaped ALLEVYN Gentle 
Border dressing can be left in place for 
up to seven days, depending on the 
condition of the wound and the 
surrounding skin or until exudate is 
visible and approaches to within 0.5cm 
of the edge of the dressing pad, 
whichever is sooner. 
6.1.3 Ancillary 
Product 
No ancillary products are to be 
provided. 
INTRASITE Gel will be provided on 
request 
for 
necrotic 
or 
sloughy 
wounds. 
6.1.6 Dressing 
Change 
Dressings can be left in place for 
up to 7 days depending on the 
condition of the wound and the 
surrounding skin or until exudate 
is visible and approaches to within 
1.5cm of the edge of the dressing 
pad, whichever is sooner. 
 
Exudate within 1.5cm of the edge 
of the pad requires changing 
 
Dressings can be left in place for up to 
7 days depending on the condition of 
the wound and the surrounding skin or 
until exudate is visible and approaches 
to within 0.5cm of the edge of the 
dressing pad, whichever is sooner. 
 
 
Exudate within 0.5cm of the edge of 
the pad requires changing 
7.1 SUBJECT 
POPULATION 
Thirty adult subjects 
Forty adult subjects 
7.2 Inclusion 
Criteria 
- 
 
 
 
 
- 
Added to the Inclusion Criteria: 
5. Presence of a moderately to highly 
exuding wound of at least 3cm2 in size. 
 
Added after Point 7 in the Inclusion 
Criteria:  
ALLEVYN Gentle Border can be cut 
and an aseptic technique should be 
used with cutting the dressing. Ensure 
any exposed foam areas are covered 
with an appropriate film dressing 
taking care not to cover the entire 
dressing. 
 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 70 of 90 
 
 
 
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 
7.6 ENROLMENT 
30 subjects 
40 subjects 
7.8.1. Withdrawal 
from Treatment 
 
Any subject that does not meet the 
minimum 
reference 
wound 
size 
requirement following wound size 
tracing at Visit 1 will be withdrawn. 
Subjects withdrawn from the study for 
this reason alone shall be replaced by 
enrolment of a new study subject. A 
new subject number will be assigned. 
8.1 Study Design 
This is a non-randomized, open 
label study in 6 study centers at 
maximum, conducted in 1-2 
countries in Europe. 30 subjects 
will be enrolled during an 
enrollment period of 13 months. 
There is no comparator group, 
however, subjects will be 
consecutively enrolled into 2 
wound groups: A minimum of 10 
subjects of acute surgical or 
traumatic wounds and a minimum 
of 10 subjects by chronic wounds. 
This is a non-randomized, open label 
study in up to 8 study centres at 
maximum, conducted in up to 3 
countries in Europe. The sample size 
is 40 subjects. There is no comparator 
group, however, subjects will be 
consecutively enrolled into 2 wound 
groups: A minimum of 10 subjects with 
acute wounds and a minimum of 10 
subjects with chronic wounds. 
9.1.2 Study Visit 
1 - Initial Visit 
(Baseline Visit, 
day 0) 
4. Provide the subject with copies 
of the CWIS, Patient Assessment 
Scale and Pain Scale, and allow 
sufficient time to complete it. 
 
- 
4. Provide the subject with the pages 
of CWIS and Patient Pain Scale, and 
allow sufficient time to complete it. 
 
 
Added after point 8:  
ALLEVYN Gentle Border can be cut 
and an aseptic technique should be 
used with cutting the dressing. Ensure 
any exposed foam areas are covered 
with an appropriate film dressing 
taking care not to cover the entire 
dressing. 
9.2.5. Patient 
Assessment Scale 
- 
Added: 
The PAS will be entered directly into 
the case report form and will serve as 
source data. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 71 of 90 
 
 
 
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 
9.2.6. Patient Pain 
Scale 
- 
Added: 
The PPS will be entered directly into 
the case report form and will serve as 
source data. 
9.2.7. Cardiff 
Wound Impact 
Questionnaire 
(CWIS) 
- 
Added: 
The CWIS will be entered directly into 
the case report form and will serve as 
source data. 
10.4.1 Analysis of 
Primary Endpoint 
The primary endpoint for this 
study is the percentage reduction 
in wound area from baseline to 
the end of study visit (28±3 days). 
The primary endpoint for this study is 
the absolute reduction in wound area 
from baseline to end of study. 
11. Sample Size 
Justification 
To calculate sample size for this 
study it is assumed that the actual 
reduction in the mean wound area 
from baseline to 28 days when 
using the dressing is 3cm2 with a 
standard deviation of 5cm2, this is 
in line with previous results seen 
in CE/046/ALF and allowing for 
marginal differences between 
study dressings. Assuming this 
data holds true it can be 
calculated that 26 subjects would 
provide 83% power to show a 
statistically significant reduction in 
the mean wound area from 
baseline to 28 days. Allowing for a 
15% lost to follow up rate, 30 
subjects will be recruited into this 
study. 
The sample size determination for 
this study was based on a previous 
study (CE/046/ALF) demonstrating an 
absolute mean reduction in wound 
area from baseline to 28 days of 3cm2 
with a standard deviation of 5cm2, in 
a range of moderate to highly exuding 
wound types. In order to show a 
statistically significant reduction in the 
mean wound area for this study, it 
was calculated that 26 subjects would 
achieve 83% power.  
 
Unfortunately, several subjects were 
recruited into the current study with 
wounds smaller than 3cm2, little to no 
exudate or chronic wounds of less 
than 6 weeks duration, meaning 
these wounds are not comparable to 
the previous study in terms of healing 
challenge. As a result, protocol 
modifications have been made to 
ensure a minimum wound size is 
included in the inclusion criteria as 
well as provide an opportunity to re-
emphasise the challenging nature of 
wounds we are seeking to recruit with 
regards to level of exudate. With this 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 72 of 90 
 
 
 
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 
in mind and accounting for the 10 
patients enrolled in the study under 
protocol V2.0 (as at 19 June 2019), it 
is recommended we increase the 
total patient recruitment target to n = 
35 patients to ensure we have 
captured a range of wounds of 
comparable healing challenge to the 
previous study.  
 
Using the same assumptions, it can 
be calculated that 35 subjects would 
provide 93% power to show a 
statistically significant reduction in the 
mean wound area from baseline to 28 
days. Analysis for this study will be 
conducted separately for patients that 
comply with V3.0 of the protocol and 
therefore the study is over-powered 
to allow for greater than 80% power 
in the V3.0 protocol population. 
  
Allowing for a 15% lost to follow up 
rate as used previously, 40 subjects 
will be recruited into this study.   
20. References 
- 
Added the references listed below 
and consequent updates to reference 
numbering throughout the protocol: 
5. 
Hurd T, Gregory L, Jones A, 
Brown S. A multi-centre in-
market evaluation of 
ALLEVYN ◊ Gentle Border. 
Wounds UK. 2009;5(3):32-44 
8.         Grothier L. Gentle foam 
dressings: interim results of an 
evaluation of the Allevyn 
range. Br J Nurs. 
2009;18(11):S12, S4, S6 
passim 
11. 
Smith&Nephew. Summary of 
Results CE/046/ALF. 2014. 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 73 of 90 
 
 
 
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 
Updated STUDY SCHEDULE:  
Table 4: Study Visits and Assessments 
Schedule of 
Events 
Key Visits  
Other Visits  
Visit 1 
(Baseline) 
 
 
Day 0 
Visit 2 
 
 
 
Day 7  
(+/-3) 
Visit 3 
 
 
 
Day 14 
(+/-3) 
Visit 4 
 
 
 
Day 21 
(+/-3) 
End of 
Study 
Visit 5 
 
Day 28 
(+/-3) 
Routine 
Dressing 
Changes 
Treatment 
Discontin
uation 
(before 
end of 
study) 
Informed 
Consent 
√ 
 
 
 
 
 
 
Demographics/ 
Medical History 
√ 
 
 
 
 
 
 
Verify Inclusion/ 
Exclusion Criteria 
√ 
 
 
 
 
 
 
Allocate Study ID 
Number 
√ 
 
 
 
 
 
 
Concomitant 
Medication 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
CWIS Patient 
Questionnaire 
√ 
√ 
√ 
√ 
√ 
 
√ 
Patient Pain 
Scale 
√ 
√ 
√ 
√ 
√ 
√ 
 
Patient 
Assessment 
 
√ 
√ 
√ 
√ 
√ 
 
Wound 
Assessment 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
Photograph 
Dressing in situ 
Before Removal 
 
√ 
√ 
√ 
√ 
√ 
√ 
Dressing Change 
 
√ 
√ 
√ 
 
√ 
 
Photograph 
Wound Before 
Dressing 
Application  
√ 
√ 
√ 
√ 
√ 
√ 
√ 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 74 of 90 
 
 
 
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 
Key Visits  
Other Visits  
Visit 1 
(Baseline) 
 
 
Day 0 
Visit 2 
 
 
 
Day 7  
(+/-3) 
Visit 3 
 
 
 
Day 14 
(+/-3) 
Visit 4 
 
 
 
Day 21 
(+/-3) 
End of 
Study 
Visit 5 
 
Day 28 
(+/-3) 
Routine 
Dressing 
Changes 
Treatment 
Discontin
uation 
(before 
end of 
study) 
Dressing 
Performance 
√ 
√ 
√ 
√ 
√ 
√ 
 
Adverse Event 
(AE) Assessment  
√ 
√ 
√ 
√ 
√ 
√ 
√ 
Record Device 
Deficiencies (DD) 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
End of Study 
/Exit Form 
 
 
 
 
√ 
 
√ 
 
21.2 
INSTRUCTIONS FOR USE 
Not attached to this protocol. Will be delivered with each ALLEVYN Gentle Border package in its 
most current version.  
21.3 
EQUIPMENT AND SPECIAL INSTRUCTIONS 
Not applicable. 
21.4 
BATES-JENSEN WOUND ASSESSMENT TOOL AND INSTRUCTIONS FOR USE 
 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
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Date: 21 JUN 2019 
Page: Page 75 of 90 
 
 
 
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 Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 76 of 90 
 
 
 
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 Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 77 of 90 
 
 
 
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 Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 78 of 90 
 
 
 
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 Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 79 of 90 
 
 
 
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 
21.5 
HEALTH ECONOMIC OUTCOME MEASURES/ QUALITY OF LIFE MEASURES 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
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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 
Cardiff Wound Impact Schedule
 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
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Date: 21 JUN 2019 
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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 
 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 82 of 90 
 
 
 
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 Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 83 of 90 
 
 
 
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 Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 84 of 90 
 
 
 
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 Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 85 of 90 
 
 
 
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 
21.6 
ADDITIONAL INFORMATION 
Not applicable. 
21.7 
PRINCIPAL INVESTIGATOR OBLIGATIONS (ISO 14155:2011) 
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: 
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.  

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
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Gentle Border 
Number: 
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Version: 3.0 
Date: 21 JUN 2019 
Page: Page 86 of 90 
 
 
 
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 
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.  
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 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 87 of 90 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
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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 
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 
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.  
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.  

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 88 of 90 
 
 
 
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. 
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 
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 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 89 of 90 
 
 
 
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 
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(s) 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. 
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 

 
Study Protocol—Device 
A Prospective, Multi-center, Post-Market Clinical Follow-Up 
Study to Evaluate the Safety and Effectiveness of ALLEVYN 
Gentle Border 
Number: 
ALLEV.PMCF.2017.13 
Version: 3.0 
Date: 21 JUN 2019 
Page: Page 90 of 90 
 
 
 
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. 
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, 
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 
e. 
supply the Sponsor, upon Sponsor's request, with any additional information related to 
the safety reporting of a particular event.