A Single Center, Open, Non-controlled Investigation to Evaluate the Performance of a Flexible, Self-adherent Absorbent Silver Dressing Coated With a Soft Silicone Layer After Elective Primary Total Hip or Knee Arthroplasty
Phase: NA
Conditions: Arthroplasties, Hip Replacement, Arthroplasties, Knee Replacement
Sponsor: Molnlycke Health Care AB

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 1(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
CLINICAL INVESTIGATION PLAN (CIP)
INVESTIGATIONAL DEVICE:
Mepilex Border Post-Op Ag
INVESTIGATION TITLE:
A single center, open, non-controlled 
investigation to evaluate the performance of a 
flexible, self-adherent absorbent silver dressing 
coated with a soft silicone layer after elective 
primary total hip or knee arthroplasty
CO-ORDINATING INVESTIGATOR:
Dr. Steven Myerthall
Center for Orthopedic Research and 
Education, Inc. d/b/a The CORE Institute
18444 N. 25th Avenue
Suite 320
Phoenix, Arizona 85023
MÖLNLYCKE CLINICAL STUDY 
MANAGER:
Tina Kjellén
Mölnlycke Health Care
P.O Box 130 80
402 52 Gothenburg, Sweden
Phone: +46 31 722 30 98

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 2(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
CLINICAL INVESTIGATION PLAN (CIP) SYNOPSIS
INVESTIGATION TITLE: 
A single center, open, non-controlled investigation to evaluate the performance of 
a flexible, self-adherent absorbent silver dressing coated with a soft silicone layer 
after elective primary total hip or knee arthroplasty
Objectives
This investigation is undertaken to investigate the performance of a self-adhesive absorbent 
post-operative silver dressing coated with a soft silicone layer in subjects undergoing elective
primary total hip or knee arthroplasty
The primary objective and outcome variable are shown in the table below::
Primary objective
Primary outcome variable
To evaluate the skin damage under 
the dressing from operation day to 
last visit
Damage to the incision and surrounding skin 
from operation day to last visit in terms of:
-
Blistering 
-
Redness 
-
Maceration 
The secondary objectives and outcome variables are shown in the table below:
Secondary objective
Secondary outcome variable
To evaluate performance of the 
dressing from operation day to last 
visit
-
Leakage 
-
Shower ability 
-
Dressing sticks to the staples/wound 
closure strips/sutures 
-
Bleeding caused by the dressing 
removal 
-
Dressing wear time (days)
-
Number of dressing changes
-
Residuals of the dressing material in 
the wound or surrounding skin
-
Dressing capacity of handling blood
To evaluate comfort, conformability 
and acceptability of the dressing from 
operation day to last visit
Nurse/Investigator evaluation 
-
Ease of application of the dressing
-
Ease of removal of the dressing

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 3(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
-
Conformation to the body contours
-
Overall experience (only at the last 
visit)
Subject evaluation 
-
Comfort when wearing the dressing
-
Ease of mobility 
-
Overall experience of the dressing 
(only at the last visit)
To evaluate pain at dressing removal 
from operation day to last visit
-
Millimeter reading on visual analogue 
scales (VAS) filled in by subject
The safety objective and outcome variables are shown in the table below:
Safety objective
Safety outcome variable
To evaluate safety of Mepilex Border 
Post-Op Ag by assessment of device 
deficiencies and adverse events, non-
serious and serious, rated for 
causality
-
Incidence of AE/ADE/SAE/SADE/DD
-
Incidence of AE/ADE/SAE/SADE/DD 
leading to withdrawal
Overall Design  
This descriptive, prospective, non-controlled clinical investigation will be conducted on 
approximately 20 enrolled subjects at one site in the US.
The target subjects are male or female, 18 years and older, undergoing elective primary hip or 
knee arthroplasty with a possibility to participate in a follow-up visit 7 days after surgery.
Subjects will consecutively be allocated to a subject ID. The subjects will be followed 1-3 days 
after surgery and scheduled for a follow-up visit 7 days after surgery.
Study Period
Estimated date of first subject enrolled
Q1 2017
Estimated date of last subject completed
Q2 2017
Estimated date of end of clinical investigation (database lock) is Q2 2017

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 4(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
Inclusion Criteria
For inclusion in the investigation, the subjects must fulfill all of the below criteria prior to 
enrollment: 
Screening Phase:
1. Age ≥18 years
2. Available for a follow-up visit including dressing change 7 days after surgery
3. Plan for elective primary hip or knee arthroplasty
4. Plan for incision size ≤18 cm
5. Provision of informed consent i.e. subject must be able to understand and sign the 
Patient Information and Consent Form
Enrollment Phase (Day of surgery)::
6. Undergoing elective primary hip or knee arthroplasty
Exclusion Criteria
Subjects who meet any of the below criteria will be excluded from the investigation:
Screening Phase:
1. Known allergy/hypersensitivity to any of the components of the dressing
2. Multi-trauma
3. Undergoing arthroplasty due to tumor 
4. Previous incision at the same knee or same side of the hip
5. Wound at the surgical site prior to surgery
6. Neurological deficit of operated side (hemiplegia, etc.)
7. Documented skin disease at time of enrollment, as judged by the investigator
8. Previously enrolled in the present investigation
9. Inclusion in other ongoing investigations at present that would preclude the subject from 
participating in this investigation as judged by the investigator
10. Involvement in the planning and conduct of the clinical investigation (applies to all MHC
staff, investigational site staff and third party vendor)
Enrollment Phase (Day of surgery):
11. Dressing size does not fit the incision size (>18 cm)
12. Complications that would increase wound risks if investigational dressing is applied

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 5(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
Schedule of Assessment
Day
Baseline 
(screening 
visit)
Day 0
Day of 
surgery
Day 
1
1st
post 
-op 
day
Day 
2
2nd
post-
op 
daya
Day 
3
3rd
post-
op 
daya
Unscheduled 
visitb
Day 7
7th
post-op 
day
Termination
Visit window/days
-21 to 0
0
0
0
0
0
-2 to 0c
0
Visit (number)
1
2
3
4
5
Unscheduled
6
Termination
Inclusion/ Exclusion 
Criteria


Informed Consent

Subject ID

Subject demography

Skin status at incision 
site

Medical /Surgical history

Type of surgery 

Surgical incision 
condition






Performance of the 
dressing






Dressing logd

()
()
()


Medication Log







Pain assessmente
()
()
()


Photosf






Nurse/investigator 
evaluationg






Subject evaluationh





Reason for termination

AE/ADE/SAE/SADE/DD







a Information will be collected at Day 3 only if the subject is still at the hospital and hasn´t been discharged
b If the dressing is changed prior to post-op day 7 and outside scheduled visits, an unscheduled visit will be performed.
c When possible, visit 6 should be scheduled to post-op day 7. When not possible due to weekends, post-op day 5 or post-op day 6 could be scheduled. 
d Dressing application/change/removal will be documented in the Dressing log. Ability to stay on (curl up at edges and partial/complete detachment) will also be 
collected 
e Pain assessment at dressing removal (VAS). If a dressing change is deemed necessary prior to visit 6, pain assessment should be collected
f Photos should be taken at visit 2 ( at the incision before application of the dressing, at dressing after application of the dressing) and if the dressing is changed at 
visit 3-6  ( at the dressing before removal of the dressing, at the incision after removal of the dressing and at dressing ( side facing the incision) , if signs of 
infection and if there in an unscheduled visit
g The nurse or the investigator will give their assessment concerning the treatment
h The nurse or the investigator will collect the subject´s experience via interview

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 6(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
If the subject is discharged prior to post-op day 2 , visit 4 and 5 will not be performed.
An occurrence of an AE/ADE/SAE/SADE/DD can be documented via photos at any time. 
Photos shall include a sticker marked with subject ID and visit number/date within the 
photograph. All photos will be checked (inspected) by Mölnlycke Health Care (MHC) personnel.
Details regarding variables to be collected are to be found in Appendix C.
Investigational Device
Mepilex Border Post-Op Ag is a soft silicone foam dressing that absorbs exudates, maintains a 
moist wound healing environment and has antimicrobial properties. The investigational device is 
a line extension under current Mepilex Border Ag 510(k) clearance (K100029).
Mepilex Border Post-Op Ag consists of a Safetac® soft silicone wound contact layer, an 
absorbent polyurethane foam pad containing a silver compound and activated carbon, a layer 
with super absorbent polyacrylate fibers, a non-woven and a vapor permeable waterproof film.
The silicone layer is covered with a polyethylene release film which is in three parts with grip 
edges for easy application.
The dressing is sterilized in ethylene oxide (EO). Further details can be found in appendix D.
For this clinical investigation, Mepilex Border Post-Op Ag will be available in the following size: 
Device (cm)
Wound pad (cm)
Border (cm)
10x25
5x20
2.5
No comparator will be used in this investigation.

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 7(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
TABLE OF CONTENTS
1.
INTRODUCTION.....................................................................................................10
1.1
Risk/benefit Assessment ...................................................................................................................11
2.
OBJECTIVES .........................................................................................................12
3.
CLINICAL INVESTIGATOR(S) AND INVESTIGATION ADMINISTRATIVE 
STRUCTURE ................................................................................................................13
3.1
Staff at Investigation site(s)...............................................................................................................13
3.2
Mölnlycke Investigation Personnel..................................................................................................13
3.3
Other Participants ...............................................................................................................................14
4.
INVESTIGATION PLAN AND PROCEDURES.......................................................14
4.1
Overall Design......................................................................................................................................14
4.2
Procedures and Assessments..........................................................................................................14
4.2.1
Schedule of Assessment ..................................................................................................................15
4.3
Selection of Population for Investigation........................................................................................16
4.3.1
Inclusion Criteria................................................................................................................................16
4.3.2
Exclusion Criteria...............................................................................................................................17
4.3.3
Withdrawal of Subjects from Treatment or Assessment.................................................................17
4.4
Investigational Device ........................................................................................................................18
4.4.1
Summary description of the Investigational Device(s)....................................................................18
4.4.2
Labelling.............................................................................................................................................18
4.4.3
Accountability.....................................................................................................................................18
4.4.4
Storage conditions.............................................................................................................................19
4.4.5
Method of Assigning Subjects to Treatment Groups ......................................................................19
4.5
Concomitant Treatments....................................................................................................................19
4.6
Performance and Safety.....................................................................................................................19
4.6.1
Subject Characteristics .....................................................................................................................19
4.6.2
Performance Measurements and Variables....................................................................................20
4.6.3
Safety Measurements and Variables...............................................................................................21
4.6.4
Anticipated ADEs...............................................................................................................................21
4.7
Data Quality Assurance......................................................................................................................22
4.7.1
Monitoring, Audits and Inspections ..................................................................................................22
4.7.2
Training of Staff .................................................................................................................................22
4.7.3
Data Management.............................................................................................................................22
4.8
Statistical Methods and Determination of Sample Size................................................................23
4.8.1
Statistical Evaluation.........................................................................................................................23
4.8.2
Determination of Sample Size..........................................................................................................24

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 8(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
4.9
Changes to the Clinical Investigation Plan.....................................................................................24
5.
STATEMENTS OF COMPLIANCE.........................................................................24
5.1
Ethics.....................................................................................................................................................24
5.1.1
Ethics review......................................................................................................................................24
5.1.2
Ethical Conduct of the Investigation.................................................................................................24
5.1.3
Patient Information and Consent Form............................................................................................24
5.2
Regulatory and standards .................................................................................................................25
5.2.1
Regulatory review..............................................................................................................................25
5.2.2
Standards and other..........................................................................................................................25
5.2.3
Subject Data Protection ....................................................................................................................25
5.3
SUBJECT PROTECTION PROCEDURES.........................................................................................25
5.3.1
Procedures in Case of Medical Emergency ....................................................................................25
5.3.2
Insurance ...........................................................................................................................................25
6.
INVESTIGATION TIMETABLE AND TERMINATION ............................................25
7.
LITERATURE REVIEW AND REFERENCES ........................................................26
8.
DEFINITIONS AND PROCEDURES FOR REPORTING OF ADVERSE EVENT, 
ADVERSE DEVICE EFFECT, SERIOUS ADVERSE EVENT, SERIOUS ADVERSE 
DEVICE EFFECT AND DEVICE DEFICIENCY.............................................................27

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 9(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
LIST OF APPENDICES
Appendix A F-449 Clinical Investigation Plan Appendix A, Core Signatures
Appendix B F-173 Patient Information and Consent Forms
Appendix C F-542 All variables to be obtained during the Investigation
Appendix D Instructions for Use 
Appendix E
Guide for Digital Photography 
LIST OF ABBREVIATIONS 
ADE
Adverse Device Effect
AE
Adverse Event
CA
Competent Authority
CIP
Clinical Investigation Plan
CRF
Case Report Form
CRM
Clinical Research Manager
DD
Device Deficiency
GCP
Good Clinical Practice
ICF
Informed Consent Form
IRB
Institutional Review Board
MHC
Mölnlycke Health Care
PI
Principal Investigator
PJI
Periprosthetic Joint Infection
SAE
Serious Adverse Event
SADE
Serious Adverse Device Effect
SSI
Surgical Site Infection
THR/THA
Total Hip replacement/Total Hip Arthroplasty
TJA
Total Joint Arthroplasty
TKR/TKA
Total Knee Replacement/Total Knee Arthroplasty

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 10(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
1.
INTRODUCTION
Total joint arthroplasty is a safe and effective procedure improving the quality of life and 
restoring function to patients with arthritis of the hip and knee. Although its general success is 
beyond dispute, postoperative complications such as periprosthetic joint infection (PJI) still 
occur1.
Most surgical wounds heal rapidly without complications; however some can become infected. 
Such infections occur when microorganisms are introduced through the surgical incision as a 
result of bacteria or fungi migration from the patient´s skin or gastrointestinal tract, direct 
transfer from surgical instruments, equipment or hands of healthcare workers or via airborne 
route.2
Every time the dressing needs to be changed, there is an increased risk of the wound becoming 
exposed to contamination. The evidence for optimal choice of dressing is based on chronic 
wounds and not surgical wounds,
2 However, in 2014, an International Consensus Meeting on 
Periprosthetic Joint Infection was held at which delegates from various disciplines worldwide 
participated and came to a consensus that an occlusive dressing after total joint arthroplasty 
(TJA) should be used.3 Occlusive dressings protect the wound from both pathogenic invasion 
and further trauma. They act as barriers and prevent the entry of outside pathogens that might 
infect the wound and delay healing. Since they conform to the body's contours, they are more 
likely to remain in place and offer protection from further trauma as well. They move as the body 
moves, making them less susceptible to shearing and tearing during the daily activities.4
NICE (2008) guidelines on the prevention and treatment of surgical site infection and the DH 
(2007) High Impact Intervention care bundle recommend that dressings applied in operating 
theatre should remain in situ for at least 48 hours before removal to prevent the entry of 
microorganisms and promote healing. Dressings should be removed before this time only if 
there is excessive leakage from the dressing. Nurses should ensure that any signs and 
symptoms of infection in patients are discussed with surgeons responsible for the care of these 
patients to ensure timely and appropriate treatment.2
Other post-operative complications are blistering and pain at dressing removal. Pain at dressing 
removal is a frequent complaint heard from patients who have their wounds dressed with gauze 
dressings that have dried into their wound. Dressings that do not cause skin damage upon 
removal are now available. The World Union of Wound Healing Societies initiative, ‘‘Principles 
of Best Practice: Minimising Pain at Dressing-Related Procedures: Implementation of Pain 
Relieving Strategies’’, recommends that clinicians use dressings that minimize trauma/pain
during application and removal.5
Even blisters lead to increased pain, delayed healing and increased susceptibility to wound 
infection as the integrity of the skin has been breached. Blistering occurs when the dermis 
becomes separated from the epidermis, which is invariably the result of continued abrasion. The 
deep, finger-like projections of epidermal tissue holding the epidermis and dermis together are 
weakened, allowing the two skin layers to separate. The incidence of wound blisters has been 
reported in the literature of between 6-24%.6
When developing postoperative wound complications and surgical site infections this can 
increase recovery times, hospital stay costs and morbidity rates.7

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 11(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
In a prospective randomized controlled study, three types of dressings (Mepore Pro, Mepilex 
Border Surgical Size and Hypafix Transparent) were compared in 150 consecutive subjects 
admitted for hip surgery with regard to prevalence of tape blisters. The blister prevalence was 
significantly lower for the Mepilex Border group (4%), than for the Mepore Pro group (51%, 
p<0.01) and Hypafix group (61%, p<0.01). The total number of dressings used during the 
hospital stay were also significantly lower for the Mepilex Border group compared to the Mepore 
Pro and Hypafix group (p<0.01). The conclusion was that the dressing with a silicone adhesive 
(Mepilex Border) significantly reduced the prevalence of blisters following hip surgery.8
In another open, prospective Post Market Clinical Follow-Up Study (MxB Po 01), Mepilex Border 
Post-Op was used in 49 patients and a standard dressing in 11 patients.
The results indicated that Mepilex Border Post-Op with the high absorption capacity, flexible 
wound pad, broader border and the skin friendly Safetac®Technology led to good stay on ability
(7 days), no blisters, no skin stripping, almost no pain at dressing removal, no dressing related 
infections and no hypersensitive reaction.13
Mepilex Border Ag is a conformable self-adherent silver dressing in the Mepilex Border 
assortment. Several investigations have been conducted showing that Mepilex Border Ag 
minimizes trauma to the wound bed and surrounding skin upon dressing removal, has good 
exudate management,9,10 reduce the number of microorganisms,10,11,12 minimizes pain to the 
patient during dressing removal, minimizes the risk of maceration and is easy to handle.9,10,11,12
The adhesive is Safetac®Technology (silicon), a unique and patented adhesive technology that 
minimizes pain to patients and trauma to wounds and the surrounding skin. Mepilex Border 
Post-Op Ag is an upgraded version of the Mepilex Border Ag and will be evaluated in this 
investigation.
The overall rationale for this investigation is to evaluate the clinical performance potential for 
Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative 
wound complications such as blistering, maceration and redness at the incision and surrounding 
skin.
1.1
Risk/benefit Assessment
Incorrect dressing selection may leads to increased rates of blistering and wound discharge. 
This, in turn, may translate into additional costs caused by the need for more dressing changes
and a prolonged hospital stay.6
Previous investigations have shown that Mepilex Border Ag with the adhesive Safetac®
Technology is effective and skin friendly. 9,10 Since the Mepilex Border Post-Op Ag is an 
upgraded version of Mepilex Border Ag the performance will be further looked at in this 
investigation. It is believed that these upgrades will give both the hospital staff and the subject 
an even better experience and satisfaction when it comes to application, conformation to the 
body contours and ability to stay on.
Site staff will be trained on how to use the investigational device and subjects will be closely 
monitored during the investigation. Adverse events (AEs), Adverse Device Effects (ADEs) 
Serious Adverse Events (SAE),  and Device Deficiencies (DD) will be registered throughout the 
investigation. The investigation will also be subjected to IRB review and approval before any 
subjects are included.

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 12(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
2.
OBJECTIVES
This investigation is undertaken to investigate the performance of a self-adhesive absorbent 
post-operative silver dressing coated with a soft silicone layer in subjects undergoing elective, 
primary, total hip or knee arthroplasty. 
The primary objective and outcome variable are shown in the table below:
Primary objective
Primary outcome variable
To evaluate the skin damage under 
the dressing from operation day to 
last visit
Damage to the incision and surrounding skin 
from operation day to last visit in terms of:
-
Blistering 
-
Redness 
-
Maceration 
The secondary objectives and outcome variables are shown in the table below:
Secondary objective
Secondary outcome variable
To evaluate performance of the 
dressing from operation day to last 
visit
-
Leakage 
-
Shower ability
-
Dressing sticks to the staples/sutures 
-
Bleeding caused by the dressing 
removal 
-
Dressing wear time (days)
-
Number of dressing changes
-
Residuals of the dressing material in 
the wound or surrounding skin
-
Dressing capacity of handling blood
To evaluate comfort, conformability 
and acceptability of the dressing from 
operation day to last visit
Nurse/investigator evaluation 
-
Ease of application of the dressing
-
Ease of removal of the dressing
-
Conformation to the body contours
-
Overall experience (only at the last 
visit)
Subject evaluation 
-
Comfort when wearing the dressing
-
Ease of mobility
-
Overall experience of the dressing
(only at the last visit)
To evaluate pain at dressing removal 
from operation day to last visit
-
Millimeter reading on visual analogue 
scales (VAS) filled in by subject

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 13(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
The safety objective and outcome variables are shown in the table below:
Safety objective
Safety outcome variable
To evaluate safety of the dressing by 
assessment of device deficiencies 
and adverse events, non-serious and 
serious, rated for causality
-
Incidence of AE/ADE/SAE/SADE/DD
-
Incidence of AE/ADE/SAE/SADE/DD 
leading to withdrawal
3.
CLINICAL INVESTIGATOR(S) AND INVESTIGATION 
ADMINISTRATIVE STRUCTURE
3.1 Staff at Investigation site(s)
Name and address of the PI at the investigation site is to be found in Appendix A.
3.2 Mölnlycke Investigation Personnel
Role in the investigation
Name
Contact information
Clinical Research Manager
Tina Kjellén
Mölnlycke Health Care AB
Byfogdegatan 1
SE-415 05 Göteborg, SWEDEN
Phone: +46 31 722 30 98
E-mail: tina.kjellen@molnlycke.com
Clinical Research Manager
David Pham
Molnlycke Health Care US, LLC
5550 Peachtree Parkway
Suite 500
Norcross, GA 30092
USA
Phone: +1 905 829 1502
E-mail: david.pham@molnlycke.com
Clinical Research 
Administrator
Annika Rydström
Mölnlycke Health Care AB
Byfogdegatan 1
SE-415 05 Göteborg, SWEDEN
Phone: +46 31 722 3000
E-mail: annika.rydstrom@molnlycke.com
Clinical Data Manager
Henrik Ahlbom
Mölnlycke Health Care AB
Byfogdegatan 1
SE-415 05 Göteborg, SWEDEN

Clinical Investigation Plan
Document 
ID: PD-
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Rev: 01
Title: CIP MxB Po Ag 01
Page 14(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
Phone: +46 31 722 3000
E-mail: henrik.ahlbom@molnlycke.com
Biostatistician
Henrik Ahlbom
Mölnlycke Health Care AB
Byfogdegatan 1
SE-415 05 Göteborg, SWEDEN
Phone: +46 31 722 3000
E-mail: henrik.ahlbom@molnlycke.com
Global Clinical Research
Director
Markus Wittebo
Mölnlycke Health Care AB
Byfogdegatan 1
SE-415 05 Göteborg, SWEDEN
Phone: +46 31 722 3000
E-mail: markus.wittebo@molnlycke.com
3.3 Other Participants
Role in the investigation
Contact information
eCRF activities
Pharma Consulting Group AB
Kungsängsvägen 19 
SE-753 23 Uppsala
Sweden
Phone: +46 18 430 3100
4.
INVESTIGATION PLAN AND PROCEDURES
4.1 Overall Design
This single center, open, non-controlled investigation will be conducted at one site , US. 
Approximately 20 male or female subjects, 18 years or older, with a planned elective primary 
total hip or knee replacement will be recruited in this investigation. The primary purpose is to 
investigate if there is any skin damage under the dressing from operation day to last visit. 
Performance of the dressing as well as comfort, conformability, acceptability and pain at
dressing removal will also be followed-up until post-op day 7. Subjects at site number 01 are 
usually sent home on post-op day two or three but this investigation will include a follow-up visit 
on post-op day 7 when the dressing is removed and the incision and incision site are inspected 
before termination. If it is not possible to schedule a visit at post-op day 7 due to weekends, it is 
ok to schedule a visit for post-op day 5 or 6. Post-op day 7 is however the day to strive for.
4.2 Procedures and Assessments
The investigational device shall be used only in this investigation and according to the Clinical 
Investigation Plan (CIP). The devices are for single use only and must be used according to 
instructions for use (Appendix D). 
Following Institutional Review Board (IRB) approval and before any investigation related 
procedure, potential subjects will be asked to sign a written informed consent form (ICF). The 
subjects will be given sufficient time for the information to be read and understood. The subject 

Clinical Investigation Plan
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Rev: 01
Title: CIP MxB Po Ag 01
Page 15(29)
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Document template: F-167 Clinical Investigation Plan
Rev: 09
will be approached and given the chance to ask any questions that have arisen after reading the 
ICF. After obtaining the subject´s written informed consent and verifying that the subject fulfills 
all inclusion and none of the exclusion criteria, the subject will participate in a screening visit 
and be allocated a subject ID. The screening visit will obtain information about the subject’s 
medical/surgical history, concomitant medication, and factors pertaining to the scheduled 
surgical procedure. Only subjects who fulfill all inclusion and none of the exclusion criteria and 
are found eligible by the investigator, will be enrolled in the investigation. The subject ID (unique 
identification code) will be recorded in the site’s all relevant investigation documentation 
pertaining to that individual.
If a subject is judged to be ineligible for enrollment, the primary reason of ineligibility will be 
documented and the subject will be considered as a screening failure. Ineligible subjects will 
receive the standard of care at the facility and no investigational documentation will be collected 
for these subjects.
4.2.1 Schedule of Assessment
All variables to be obtained during the Investigation are to be found 4.6.1, 4.6.2, 4.6.3 and
in Appendix C.
Schedule of Assessment
Day
Baseline 
(screening 
visit)
Day 0
Day of 
surgery
Day 
1
1st
post 
-op 
day
Day 
2
2nd
post-
op 
daya
Day 
3
3rd
post-
op 
daya
Unscheduled 
visitb
Day 7
7th
post-op 
day
Termination
Visit window/days
-21 to 0
0
0
0
0
0
-2 to 0c
0
Visit (number)
1
2
3
4
5
Unscheduled
6
Termination
Inclusion/ Exclusion 
Criteria


Informed Consent

Subject ID

Subject demography

Skin status at incision 
site

Medical /Surgical history

Type of surgery 

Surgical incision 
condition






Performance of the 
dressing






Dressing logd

()
()
()



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Rev: 01
Title: CIP MxB Po Ag 01
Page 16(29)
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Document template: F-167 Clinical Investigation Plan
Rev: 09
Day
Baseline 
(screening 
visit)
Day 0
Day of 
surgery
Day 
1
1st
post 
-op 
day
Day 
2
2nd
post-
op 
daya
Day 
3
3rd
post-
op 
daya
Unscheduled 
visitb
Day 7
7th
post-op 
day
Termination
Medication Log







Pain assessmente
()
()
()


Photosf






Nurse/investigator 
evaluationg






Subject evaluationh





Reason for termination

AE/ADE/SAE/SADE/DD







a Information will be collected at Day 3 only if the subject is still at the hospital and hasn´t been discharged
b If the dressing is changed prior to post-op day 7 and outside scheduled visits, an unscheduled visit will be performed.
c When possible, visit 6 should be scheduled to post-op day 7. When not possible due to weekends, post-op day 5 or post-op day 6 could be scheduled. 
d Dressing application/change/removal will be documented in the Dressing log. Ability to stay on (curl up at edges and partial/complete detachment) will also be 
collected 
e Pain assessment at dressing removal (VAS). If a dressing change is deemed necessary prior to visit 6, pain assessment should be collected
f Photos should be taken at visit 2 ( at the incision before application of the dressing, at dressing after application of the dressing) and if the dressing is changed at 
visit 3-6  ( at the dressing before removal of the dressing, at the incision after removal of the dressing and at dressing ( side facing the incision) , if signs of 
infection and if there in an unscheduled visit
g The nurse or the investigator will give their assessment concerning the treatment
h The nurse or the investigator will collect the subject´s experience via interview
4.3 Selection of Population for Investigation
4.3.1 Inclusion Criteria
For inclusion in the investigation, the subjects must fulfill all of the below criteria prior to 
enrollment: 
Screening Phase:
1. Age ≥18 years
2. Available for a follow-up visit including dressing change 7 days after surgery
3. Plan for elective primary hip or knee arthroplasty
4. Plan for incision size ≤18 cm
5. Provision of informed consent i.e. subject must be able to understand and sign the 
Patient Information and Consent Form
Enrollment Phase (Day of surgery)::
6. Undergoing elective primary arthroplasty of the hip or knee. 

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Title: CIP MxB Po Ag 01
Page 17(29)
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MxB Po Ag 01 Final Version
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Document template: F-167 Clinical Investigation Plan
Rev: 09
4.3.2 Exclusion Criteria
Subjects who meet any of the below criteria will be excluded from the investigation:
Screening Phase:
1. Known allergy/hypersensitivity to any of the components of the dressing
2. Multi-trauma
3. Undergoing arthroplasty due to tumor 
4. Previous incision at the same knee or same side of the hip
5. Wound at the surgical site prior to surgery
6. Neurological deficit of operated side (hemiplegia, etc.)
7. Documented skin disease at time of enrollment, as judged by the investigator
8. Previously enrolled in the present investigation
9. Inclusion in other ongoing investigations at present that would preclude the subject from 
participating in this investigation as judged by the investigator 
10. Involvement in the planning and conduct of the clinical investigation (applies to all MHC
staff, investigational site staff and third party vendor)
Enrollment Phase (Day of surgery):
11. Dressing size does not fit the incision area (>18 cm)
12. Complications that would increase wound risks if investigational dressing is applied
4.3.3 Withdrawal of Subjects from Treatment or Assessment
Subjects are free to discontinue participation in the investigation at any time, and without 
prejudice to further treatment. Subjects who discontinue the investigation should always be 
asked about the reason(s) for their discontinuation and about the presence of any Adverse 
Event/Adverse Device Effect or Device Deficiency and, if possible, be assessed by an 
investigator. Adverse Event/Adverse Device Effect should be followed up. 
Subjects may be withdrawn from investigation treatment and assessments at any time, at the 
discretion of the investigator.
Incorrectly enrolled subjects will be withdrawn from further investigation treatment and 
assessments. A subject may, however, continue the investigation under special circumstances 
(i.e. if continuation of investigation treatment or follow-up actions are necessary for the subject’s 
safety and well-being, or if only a follow-up period remains, and the continuation of the 
investigation is not expected to be associated with any risk or discomfort for the subject)

Clinical Investigation Plan
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ID: PD-
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Rev: 01
Title: CIP MxB Po Ag 01
Page 18(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
4.4 Investigational Device
4.4.1 Summary description of the Investigational Device(s)
Mepilex Border Post-Op Ag is a soft silicone foam dressing that absorbs exudates, maintains a 
moist wound healing environment and has antimicrobial properties. The investigational device is 
a line extension under current Mepilex Border Ag 510(k) clearance (K100029).
Mepilex Border Post-Op Ag consists of a Safetac® soft silicone wound contact layer, an 
absorbent polyurethane foam pad containing a silver compound and activated carbon, a layer 
with super absorbent polyacrylate fibers, a non-woven and a vapor permeable waterproof film.
The silicone layer is covered with a polyethylene release film which is in three parts with grip 
edges for easy application.
The dressing is sterilized in ethylene oxide (EO). Further details can be found in appendix D.
For more information regarding the investigational device, instructions for use and precautions, 
please see Appendix D - Instructions for use. 
For this clinical investigation, Mepilex Border Post-Op Ag will be available in the following size
Device (cm)
Wound pad (cm)
Border (cm)
10x25
5x20
2.5
4.4.2 Labelling
MHC will provide the investigational medical devices to the investigation site for free. Labelling 
of the investigational medical device will be performed in accordance with Good Manufacturing 
Practice (GMP). The labels will be produced in the local language and in accordance with local 
regulations for the US. The medical device will be marked with the following text:
Mepilex Border Post-Op Ag
Study Code: MxB Po Ag 01
“CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational 
use."
4.4.3 Accountability
The investigational devices will not be distributed to the investigation site until all agreements 
between the investigator and MHC are finalized and IRB approval has been obtained. All 
investigational devices must be kept in a secure place under appropriate storage conditions.
Use of investigational devices will be logged in a separate accountability form stored in the 
Investigator Site File and be reviewed at each monitoring visit. The investigational devices may 
only be used in this clinical investigation and according to the CIP. 
The principal investigator or an authorized designee shall keep records documenting the 
receipt, use, return and disposal of the investigational devices.
Unused products are accounted for and returned to MHC for destruction, or destroyed locally 
upon agreement with and approval from MHC. 
Applicable documents are the “Certificate of Delivery of Investigational Device/Material”, the 
“Accountability Form” and the “Certificate of Return and Destruction of Investigation Product”.

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Document 
ID: PD-
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Rev: 01
Title: CIP MxB Po Ag 01
Page 19(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
4.4.4 Storage conditions
Investigational medical devices are to be handled and stored safely, properly and in agreement 
with the given storage instructions. Mepilex Border Post-Op Ag should be stored in dry 
conditions and protected from direct sunlight. A description of the appropriate storage and 
shipment conditions are specified on the investigational medical device label and in the 
instructions for use documentation (IFU), Appendix D.
4.4.5 Method of Assigning Subjects to Treatment Groups
The investigation is an open, non-controlled investigation and hence, all subjects who fulfill all 
inclusion and none of the exclusion criteria will be enrolled to the investigation.
If a subject discontinues from the investigation, the subject ID will not be reused and the subject 
will not be allowed to re-enter the investigation.
4.5 Concomitant Treatments
Medication, which is considered necessary for the subject’s safety and well-being, may be given 
at the discretion of the investigator. All concomitant medication and relevant treatment must be 
recorded in the appropriate section of the Case Report Form (CRF). 
Only antiseptics, anticoagulants, antibiotics and analgesics as well as skin related medication 
and those related to medical/surgical history and AEs are to be collected and reported in the 
Medication log.
4.6 Performance and Safety
4.6.1 Subject Characteristics
The following subject characteristics (demographics) will be recorded in the eCRF:
-
Date of birth (dd-mm-yyyy)
-
Gender (f/m)
-
Weight (kg)
-
Height (cm)
-
BMI
-
Medical History
-
Surgical History
-
Skin Status at Incision ( type of skin (normal, dry, flaky, oily, moist, other)
-
Type of Surgery ( primary hip or knee arthroplasty, length of incision and type of incision 
closure)
-
Surgical incision condition (compression over the incision)
-
Drainage used (N/Y)
-
Drainage placed (outside the dressing border, under the dressing border)
-
Exudate level 

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Title: CIP MxB Po Ag 01
Page 20(29)
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Document template: F-167 Clinical Investigation Plan
Rev: 09
-
Exudate nature
-
Signs of local/systemic infection and systemic antibiotic given for the local/systematic 
infection
4.6.2
Performance Measurements and Variables
Primary objective
Outcome variable
Method
To evaluate the skin damage 
from operation day to last visit
Damage to the incision and 
surrounding skin (blistering, 
redness, maceration)
Nurse or investigator 
assessment.
Secondary objective
Outcome variable
Method
To evaluate performance of 
the dressing from operation 
day to last visit
a. Incidence of  Leakage
a. Nurse or investigator 
assessment (N/Y)
b. Shower ability 
b. Nurse or investigator 
assessment (NA/N/Y)
c.
Dressing sticks to the 
staples/wound closure 
strips/sutures 
c.
Nurse or investigator 
assessment (N/Y)
d. Bleeding at dressing 
removal
e. Dressing wear time
d. Nurse or investigator 
assessment (N/Y)
e. Nurse or investigator 
assessment (days)
f.
Number of dressing 
changes
g. Residuals of the 
dressing material in 
the wound or 
surrounding skin
h. Dressing capacity of 
handling blood
f.
Nurse or investigator 
assessment (Dressing 
log)
g. Nurse or investigator 
assessment (N/Y)
h. Nurse or investigator 
assessment (N/Y)
To evaluate comfort, 
conformability and 
acceptability of the dressing 
from operation day to last visit
i.
Ease of application of 
the dressing
i-m. Nurse/investigator 
evaluation (NA/ Poor/ Good/ 
Very Good/ Excellent)
j.
Ease of removal of the 
dressing

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Title: CIP MxB Po Ag 01
Page 21(29)
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Document template: F-167 Clinical Investigation Plan
Rev: 09
k.
Conformation to the 
body contours
l.
Overall experience
m. Comfort when wearing 
the dressing 
n. Ease of mobility
o. Overall experience of 
the dressing
n-o. Subject evaluation (NA/ 
Poor/ Good/ Very Good/ 
Excellent)
To evaluate pain at dressing 
removal from operation day to 
last visit
Pain
Millimeter reading on visual 
analogue scales (VAS) filled 
in by subject. The results will 
be transferred to the eCRF by 
the staff at the investigation 
site
4.6.3 Safety Measurements and Variables
Adverse Event (AE)/Adverse Device Effect (ADE), Serious Adverse Event (SAE)/Serious 
Adverse Device Effect (SADE) and Device Deficiencies (DD). The definition of AE, ADE, SAE, 
SADE and DD and procedures for reporting SAE and SADE and DD that could have led to a 
SADE are presented in section 8 of this CIP. All AE, ADE, SAE, SADE and DD must also be 
recorded in the appropriate section of the CRF. It is of utmost importance that all staff involved 
in the investigation is familiar with the content of section 8. It is the responsibility of the Principal 
Investigator to ensure this.
4.6.4 Anticipated ADEs 
The following events have been identified as anticipated effects in the Product Risk 
Management Record:

Wound dry out

Maceration

Infection

Pain and discomfort

Skin irritation
The conclusion of the Product Risk Management Record is as following:
Based on the risk management record it can be concluded that for Mepilex Border Post-Op Ag 
products, there are no unacceptable risks of harm to the subject, the user nor third party 
involved in this device when used under normal conditions and for its intended use.

Clinical Investigation Plan
Document 
ID: PD-
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Rev: 01
Title: CIP MxB Po Ag 01
Page 22(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
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Document template: F-167 Clinical Investigation Plan
Rev: 09
4.7 Data Quality Assurance
4.7.1 Monitoring, Audits and Inspections
During the investigation, the monitor will have regular contacts with the investigation site. These 
contacts will include visits to confirm that the facilities remain adequate to specified standards 
and that the investigation site team is carrying out the procedure stated in the clinical 
investigation plan and supports the investigator. All data must be accurately recorded in the 
CRF. Source data verification (a comparison of data in the CRF with the subject’s 
hospital/practice and other records at the investigation site) with direct access to records will 
also be performed.
The monitor or other Mölnlycke Health Care (MHC) personnel will be available between visits if 
the investigator or other staff at the site needs information and/or advice. 
Authorized representatives of MHC and/or a Competent Authority (CA) and/or the Institutional 
Review Board (IRB) may visit the investigation site to perform audits/inspections, including 
source data verification.
4.7.2 Training of Staff
The Principal Investigator will ensure that appropriate training relevant to the investigation is 
given to the medical, nursing and other staff at the site involved and that new information of 
relevance to the performance of this investigation is forwarded to the staff involved.
Before the first subject is entered into the investigation, Mölnlycke Health Care personnel will 
conduct a site initiation visit. The purpose of the visit is to provide training to the involved site 
personnel including, but not limited to the following items: 

Clinical investigation plan (CIP) and execution thereof 

Use of the investigational device 

Use of the eCRF system

Study Equipment to be used

Maintenance of Investigator Site File (ISF)
The staff at the investigational site will sign a confirmation document that they are trained in how 
to use the investigational device. Only trained staff (who has received delegation from the PI) 
will be allowed to apply and remove the dressings for a given subject..
4.7.3 Data Management
The Data Management process includes all activities related to data handling regarding:

Set-up of eCRF and database

Specification of on-line checks

Data entry / Data editing

Export of data from Viedoc to SAS

Creation of post-entry checks and listings

Reconciliation of Serious Adverse Event (SAE), Serious Adverse Device Effect 
(SADE), Adverse Devise Effect (ADE) and Device Deficiency (DD)

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Title: CIP MxB Po Ag 01
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Document template: F-167 Clinical Investigation Plan
Rev: 09

Clean-file process including execution of post-entry checks and listings

Post clean-file tasks
Pharma Consulting Group will build and set up Viedoc, a web based electronic CRF system that
will be used to capture data in this investigation. The eCRF system complies with FDA Title 21 
CRF part 11 (ER/ES) requirement.
eCRF training will be given to appropriate personnel before/at initiation of the investigation 
site(s). 
Data entry will be done by investigators and other authorized personnel at the site(s). When 
entering data, on-line checks are incorporated in Viedoc for consistency and validation.
Pharma Consulting Group will support with a helpdesk function taking care of system user 
questions regarding Viedoc.
When data has been entered authorized personnel at MHC can immediately view the data, 
send queries if necessary and lock eCRF pages when they have been validated. 
Photos will be uploaded in Viedoc and are marked with the subject ID. Uploaded photos shall 
not contain any information that can reveal the identity of the subject. All uploaded photos will 
be reviewed by personnel at MHC and stored in the company database. All data entered in 
Viedoc will be encrypted. The physical database will be stored in Sweden.
Programs for post-entry checks and data listings will be created and executed for validation of 
data. 
Completeness will be checked by authorized personnel at MHC so that there are no 
unexplainable empty fields in Viedoc. This is done in order to prevent that data being
overlooked by personnel entering the data.
A clean-file meeting will be held prior to database lock. All decisions on the evaluability of the 
data from each individual subject for the statistical analysis must be made and documented 
before locking the database. Readable copies of the eCRF data will be archived in the 
Investigator Site File (ISF) at the investigation site after clean file.
Data will be retained for at least 10 years after investigation closure.
4.8 Statistical Methods and Determination of Sample Size
4.8.1 Statistical Evaluation
Presentation of the data 
The results from this open, non-controlled clinical investigation will be presented with descriptive 
statistics. No hypothesis testing is planned for this investigation.
Data listings will be prepared for all data. Certain data will be collated into summary tables and 
figures. Those summary tables and figures will be integrated into the body of the investigation 
report. 
Populations for analysis
Safety population
The population for the assessment of safety will include all enrolled subjects who provide at 
least the baseline visit.
ITT population
The Intention to Treat (ITT) population will include all subjects to at least one post-enrolment 
treatment. 

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Document template: F-167 Clinical Investigation Plan
Rev: 09
PP population
The Per Protocol (PP) population will include all subjects without significant protocol violations. 
Subjects identified as protocol violators will be documented and agreed upon before declaration 
of clean-file. 
Baseline characteristics
All variables measured at baseline will be summarized for the ITT- and PP population using 
appropriate summary statistics.
Performance and safety measurement
All endpoints will be summarized as above and by visit. The result from the CRF will be 
summarized appropriately for all evaluable subjects. 
The number of subjects reporting one or more adverse events during the course of the 
investigation will be summarized using frequency counts.
4.8.2 Determination of Sample Size
This is a descriptive investigation and the number of subjects have been chosen to be able to 
find explorative trends.
4.9 Changes to the Clinical Investigation Plan
No change in the investigation procedure will be effected without the mutual agreement of the 
Principal Investigator and MHC.
An amendment to the Investigation Plan may require notification or approval from IRB before 
implementation. Local requirements must be followed.
MHC will distribute clinical investigation plan amendments to the Principal Investigator who is 
responsible for the distribution of these documents to the IRB and staff involved at his/her site. 
5.
STATEMENTS OF COMPLIANCE
5.1 Ethics
5.1.1 Ethics review 
The final clinical investigation plan, including the final version of the Patient Information and 
Consent Form, must be approved or given a favorable opinion in writing by an IRB before 
enrollment of any subject into the investigation. The Principal Investigator is responsible for 
informing the IRB of any amendment to the investigation plan as per local requirements.
5.1.2 Ethical Conduct of the Investigation
The investigation will be performed in accordance with the ethical principles that have their 
origin in the most recent version of the Declaration of Helsinki, and with applicable regulatory 
requirements. Patients, who are close colleagues, associates, or family members of, or in any 
way dependent on the sponsor or the investigator, will not be included in this investigation. 
5.1.3 Patient Information and Consent Form
The Principal Investigator will ensure that the subject is given full and adequate oral and written 
information about the nature, purpose, possible risks and benefits of the investigation. Subjects 
must also be notified that they are free to discontinue participation in the investigation at any 
time. The subject should be given the opportunity to ask questions and time for consideration. 

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Title: CIP MxB Po Ag 01
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Document template: F-167 Clinical Investigation Plan
Rev: 09
The subject’s signed informed consent has to be obtained before conducting any investigation 
related procedures. The original must be filed by the Principal Investigator. A copy of the Patient 
Information including the signed Consent Form should be given to the subject.
A sample of the Patient Information and Consent Form is enclosed (Appendix B). If 
modifications are made according to local requirements, the new version must be approved by 
MHC.
5.2 Regulatory and standards
5.2.1 Regulatory review
If applicable, the final clinical investigation plan, including the final version of the Patient 
Information and Consent Form, must be approved or given a favorable opinion in writing by a 
CA before enrollment of any subject into the investigation. MHC is responsible for informing the 
CA of any amendment to the investigation plan as per local requirements.
5.2.2 Standards and other
The most recent version of ISO 14155 is followed in addition to national regulations, 21 CFR 50 
Protection of Human Subjects, 21 CFR 56 Institutional Review Boards and 21 CFR 54 Financial 
Disclosure.
5.2.3 Subject Data Protection
The written Patient Information explains that the data will be stored in a computer database, 
maintaining confidentiality in accordance with national data legislation and that authorized 
representatives of MHC and/or IRB, require direct access to those parts of the hospital/practice 
records relevant to the investigation, including medical history, for verification of data. All data 
computerized by MHC will be identified by subject ID only.
5.3 SUBJECT PROTECTION PROCEDURES
5.3.1 Procedures in Case of Medical Emergency
The Principal Investigator is responsible for ensuring that procedures and expertise are 
available to cope with medical emergencies during the investigation.
5.3.2 Insurance
Mölnlycke Health Care AB has product liability insurance, which also covers test products.
6.
INVESTIGATION TIMETABLE AND TERMINATION
Investigation start: Q1 2017
Inclusion completed: Q2 2017
Last subject out: Q2 2017
The investigation could be prematurely discontinued if the investigation site is unable to fulfill
the inclusion period according to the Clinical Investigation Agreement.

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Document template: F-167 Clinical Investigation Plan
Rev: 09
7.
LITERATURE REVIEW AND REFERENCES
1. Parvizi J, Pawasarat IM, Azzam KA, et al. Periprosthetic joint infection: the economic 
impact of methicillin-resistant infections. JOA 2010;25(6 Sup):103.
2. Harrington P (2014) Prevention of surgical site infection. Nursing Standard. 28, 48, 50-58. 
Date of submission: March 7 2014; date of acceptance: April 28 2014.
3. Elie Ghanem, E., Heppert, V. et al., Wound Managment. J Orthop Res 32: 108–S119,
2014
4. Rheinecker,s., Wound Management: The Occlusive Dressing. J Athl Train. 1995 Jun; 
30(2): 143-144, 146
5. Baranoski S, Ayello EA.,  Wound dressings: an evolving art and science. Adv Skin Wound 
Care. 2012 Feb;25(2):87-92
6. Cosker, T., Elsayed, S., Gupta, S. et al. Choice of dressing has a major impact on 
blistering and healing outcomes in orthopaedic patients. J Wound Care 2005; 14: 1, 27-
29.
7. Tustanowski, J. Effect of dressing choice on outcomes after hip and knee arthroplasty: a 
literature review. J Wound Care 2009; 18: 11, 449-454.
8. Côte M, Provost J, Denault A, Pelet S. 2010. Presentation on 66th Annual Meeting of 
Canadian Orthopedic Association: Reduction of tape blisters after hip surgery; A 
prospective evaluation of three kinds of bandages.
9. Davis, D. Use of an antimicrobial Soft Silicone Borded Foam Dressing as an Adjunctive 
Treatment with a Single Layer Bioengineered Dermal Tissue, Poster at SAWC 2012
10. Davies, P. Mepilex® Border Ag: A Global In-Market Evaluation (Former Follow-up of the 
intended use of Mepilex Border Ag), 2013
11. Latenser, B. Open multi-centre investigation to evaluate signs and symptoms of local
inflammation/infection on chronic ulcers and partial thickness burns when using Mepilex
Border Ag as an anti-microbial wound dressing. MxB Ag 01, 2012
12. Huss, F. An open, non-controlled, post-marketing investigation evaluating the experience 
of using a self-adherent antimicrobial soft silicone, silver containing, foam dressing, 
Mepilex Border Ag, in second degree burns MxB Ag, 2011
13. Zarghooni K., Lohmann C., Bredow N., Oppermann A., Krueger B., Wenk J., Meyer H. 
Effect of a modern dressing compared to a standard dressing on outcome after primary 
hip and knee arthroplasty, prospective non randomised study. Poster EWMA 2015

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 27(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
8.
DEFINITIONS AND PROCEDURES FOR REPORTING OF 
ADVERSE EVENT, ADVERSE DEVICE EFFECT, SERIOUS 
ADVERSE EVENT, SERIOUS ADVERSE DEVICE EFFECT 
AND DEVICE DEFICIENCY 
Definitions:
Device Deficiency (DD)
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or 
performance.
Note: 

Device Deficiencies include malfunctions, use errors, and inadequate labelling. 
All Device Deficiencies that might have led to a Serious Adverse Device Effect shall be reported 
in accordance with Serious Adverse Event reporting procedures, as specified below.
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device
Note: 

This definition includes events related to the investigational medical device or the 
comparator.

This definition includes events related to the procedures involved.

For users or other persons, this definition is restricted to events related to 
investigational medical devices.
Adverse Device Effect (ADE) 
Adverse Event related to the use of an investigational medical device 
Note: 

This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, or operation, or any malfunction of 
the investigational medical device.

This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device.
Serious Adverse Event (SAE)
Adverse Event that:
a)
led to death,
b)
led to a serious deterioration in the health of the subject, that either resulted in
1) a life-threatening illness or injury, or
2) a permanent impairment of a body structure or a body function, or

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 28(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
3) in-patient hospitalization or prolonged hospitalization or,
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function.
c)
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 CIP, without 
serious deterioration in health, is not considered a serious adverse event.
Serious Adverse Device Effect (SADE)
Adverse Device Effect that has resulted in any of the consequences characteristic of a Serious 
Adverse Event.
PROCEDURES FOR SAE AND/OR SADE REPORTING OR REPORTING OF DD THAT 
COULD HAVE LED TO A SADE
The investigator must inform Mölnlycke Health Care (MHC), within 1 calender day of awareness 
of the event. When a SAE/SADE has been entered into the eCRF by the investigator 
/authorised site staff, the eCRF system will automatically generate a report to: 
Clinical_Investigations_Event_Reporting@molnlycke.com.
In case of problem with the eCRF, a paper based version of the SAE/SADE report form 
(available in the Investigator Site File) shall be used and sent by email to: 
Clinical_Investigations_Event_Reporting@molnlycke.com.
All SAEs/SADEs that occurs during the Clinical Investigation shall be reported, whether or not 
they are considered causally related to the investigational device.
Device Deficiencies that might have led to SADE if either a) suitable action had not been taken, 
b) if intervention had not been made, or c) if circumstances had been less fortunate must be 
reported as a SADE.
The investigator is responsible for informing the EC/IRB and/or the Competent Authority of the 
SAE/SADE as per local requirements.
PROCEDURES FOR DD REPORTING 
All DD shall be reported to MHC as soon as possible, without unjustified delay . If the DD might 
have led to a SADE the reporting requirements for SADE described above must be followed. 
DDs can be either subject related or non-subject related depending on if the investigational 
device was used by a subject or not. Separate forms are used for subject related and non-

Clinical Investigation Plan
Document 
ID: PD-
492446
Rev: 01
Title: CIP MxB Po Ag 01
Page 29(29)
Investigation Code
MxB Po Ag 01 Final Version
Approval date
2016-11-15
Document template: F-167 Clinical Investigation Plan
Rev: 09
subject related DDs. When a subject related DD has been entered into the eCRF by the 
investigator /authorised site staff, the eCRF system will automatically generate a report to: 
Clinical_Investigations_Event_Reporting@molnlycke. 
Non-subject related DDs are reported using the paper based report form located in the 
Investigator Site File. The completed form shall be sent by email to 
Clinical_Investigations_Event_Reporting@molnlycke.com
Causality Assessment
The relationship between the use of the investigational device and the occurrence of each 
AE/SAE shall be assessed by the investigator and the sponsor and classified as investigational 
device related or not related to investigational device.

CIP Amendment 
Document ID:  PD-521925 Rev: 00 
Title: CIP Amendment 01 
Page 1(6) 
Investigation Code MxB Po Ag 01Final Version 
CIP Approval date 2016-11-15 
Amendment Final Version 
Amendment Approval date 2016-11-21 
 
Document template: F-168 CIP Amendment 
Rev: 04 
 
 
CLINICAL INVESTIGATION PLAN (CIP) Central AMENDMENT no 1 
Substantial 
  
INVESTIGATIONAL DEVICE:  
Mepilex Border Post-Op Ag 
INVESTIGATION TITLE:  
 
A single center, open, non-controlled investigation to evaluate the performance of a 
flexible, self-adherent absorbent silver dressing coated with a soft silicone layer 
after elective primary total hip or knee arthroplasty 
 
SITES AFFECTED BY THE AMENDMENT: 
The amendment affect all in the study 
 
 
 
 

CIP Amendment 
Document ID:  PD-521925 Rev: 00 
Title: CIP Amendment 01 
Page 2(6) 
Investigation Code MxB Po Ag 01Final Version 
CIP Approval date 2016-11-15 
Amendment Final Version 
Amendment Approval date 2016-11-21 
 
Document template: F-168 CIP Amendment 
Rev: 04 
 
 
THE CLINICAL INVESTIGATION PLAN (CIP) IS TO BE AMENDED AS FOLLOWS: 
 
Section and page in the Clinical Investigation Plan (CIP): 
 
CIP section: Synopsis /  Overall Design   
CIP page: 3 
 
From:  
This descriptive, prospective, non-controlled clinical investigation will be conducted on 
approximately 20 enrolled subjects at one site in the US. 
The target subjects are male or female, 18 years and older, undergoing elective primary hip or 
knee arthroplasty with a possibility to participate in a follow-up visit 7 days after surgery. Subjects 
will consecutively be allocated to a subject ID. The subjects will be followed 1-3 days after surgery 
and scheduled for a follow-up visit 7 days after surgery. 
 
To: 
This descriptive, prospective, non-controlled clinical investigation will be conducted on 
approximately 20 enrolled subjects at one site in the US. 
The target subjects are male or female, 18 years and older, undergoing elective primary hip or 
knee arthroplasty with a possibility to participate in a follow-up visit 7 days after surgery. Subjects 
will consecutively be allocated to a subject ID. 
Subjects at site number 01 are usually sent home on post-op day one (1) or two (2). If the subject 
are sent home post-op day two (2) this investigation will include a telephone follow-up on post-op 
day two (2), clinic visit on post-op day three (3) and a follow-up visit on post-op day 7 when the 
dressing is removed and the incision and incision site are inspected before termination. If the 
dressing is changed prior to post-op day 7 and outside scheduled visits, an unscheduled visit will 
be performed. 
 
CIP section: Synopsis / Schedule of Assessment & 4.2.1 Schedule of Assessment 
CIP page: 5 & 15 
From:  
Day 
Baseline 
(screening 
visit) 
Day 0 
Day of 
surgery 
Day  
1 
1st 
post -
op 
day 
Day  
2 
2nd 
post-
op 
daya 
Day  
3 
3rd 
post-
op 
daya 
Unscheduled 
visitb 
Day 
7 
7th 
post-
op 
day 
Termination 
Visit window/days 
-21 to 0 
0 
0 
0 
0 
0 
-2 to 
0c 
0 
Visit (number) 
1 
2 
3 
4 
5 
Unscheduled 
6 
Termination 

CIP Amendment 
Document ID:  PD-521925 Rev: 00 
Title: CIP Amendment 01 
Page 3(6) 
Investigation Code MxB Po Ag 01Final Version 
CIP Approval date 2016-11-15 
Amendment Final Version 
Amendment Approval date 2016-11-21 
 
Document template: F-168 CIP Amendment 
Rev: 04 
 
 
Day 
Baseline 
(screening 
visit) 
Day 0 
Day of 
surgery 
Day  
1 
1st 
post -
op 
day 
Day  
2 
2nd 
post-
op 
daya 
Day  
3 
3rd 
post-
op 
daya 
Unscheduled 
visitb 
Day 
7 
7th 
post-
op 
day 
Termination 
Inclusion/ Exclusion 
Criteria 
 
 
 
 
 
 
 
 
Informed Consent 
 
 
 
 
 
 
 
 
Subject ID 
 
 
 
 
 
 
 
 
Subject demography 
 
 
 
 
 
 
 
 
Skin status at incision 
site 
 
 
 
 
 
 
 
 
Medical /Surgical 
history 
 
 
 
 
 
 
 
 
Type of surgery  
 
 
 
 
 
 
 
 
Surgical incision 
condition 
 
 
 
 
 
 
 
 
Performance of the 
dressing 
 
 
 
 
 
 
 
 
Dressing logd 
 
 
() 
() 
() 
 
 
 
Medication Log 
 
 
 
 
 
 
 
 
Pain assessmente 
 
 
() 
() 
() 
 
 
 
Photosf 
 
 
 
 
 
 
 
 
Nurse/investigator 
evaluationg 
 
 
  
  
  
 
  
 
Subject evaluationh 
 
 
 
 
 
 
 
 
Reason for termination 
 
 
 
 
 
 
 
 
AE/ADE/SAE/SADE/DD 
 
 
 
 
 
 
 
 
a Information will be collected at Day 3 only if the subject is still at the hospital and hasn´t been discharged 
b If the dressing is changed prior to post-op day 7 and outside scheduled visits, an unscheduled visit will be performed. 
c When possible, visit 6 should be scheduled to post-op day 7. When not possible due to weekends, post-op day 5 or post-op day 6 could be scheduled.  
d Dressing application/change/removal will be documented in the Dressing log. Ability to stay on (curl up at edges and partial/complete detachment) will also be 
collected  
e Pain assessment at dressing removal (VAS). If a dressing change is deemed necessary prior to visit 6, pain assessment should be collected 
f Photos should be taken at visit 2 ( at the incision before application of the dressing, at dressing after application of the dressing) and if the dressing is changed at visit 
3-6  ( at the dressing before removal of the dressing, at the incision after removal of the dressing and at dressing ( side facing the incision) , if signs of infection and if 
there in an unscheduled visit 
g The nurse or the investigator will give their assessment concerning the treatment 
h The nurse or the investigator will collect the subject´s experience via interview 
 

CIP Amendment 
Document ID:  PD-521925 Rev: 00 
Title: CIP Amendment 01 
Page 4(6) 
Investigation Code MxB Po Ag 01Final Version 
CIP Approval date 2016-11-15 
Amendment Final Version 
Amendment Approval date 2016-11-21 
 
Document template: F-168 CIP Amendment 
Rev: 04 
 
 
 
 
To: 
Day 
Baseline 
(screening 
visit) 
Day 0 
Day of 
surgery 
Day 1 
1st 
post -
op 
day 
Day  
2 
2nd 
post-
op 
daya 
Day  
2 
2nd post-
op  
Telephone 
Follow-Up i   
Day 3 
3rd 
post-
op 
daya 
Un-
scheduled 
visitb 
Day 
7 
7th 
post-
op 
day 
Term-
ination 
Visit window/days 
-21 to 0 
0 
0 
0 
0 
0 
0 
-2 to 
0c 
0 
Visit (number) 
1 
2 
3 
4 
4 
5 
Un-
scheduled 
6 
Term-
ination 
Inclusion/ Exclusion 
Criteria 
 
 
 
 
 
 
 
 
 
Informed Consent 
 
 
 
 
 
 
 
 
 
Subject ID 
 
 
 
 
 
 
 
 
 
Subject demography 
 
 
 
 
 
 
 
 
 
Skin status at incision 
site 
 
 
 
 
 
 
 
 
 
Medical /Surgical history 
 
 
 
 
 
 
 
 
 
Type of surgery  
 
 
 
 
 
 
 
 
 
Surgical incision 
condition 
 
 
 
 
 
 
 
 
 
Performance of the 
dressing 
 
 
 
 
 
 
 
 
 
Dressing logd 
 
 
() 
() 
 
() 
 
 
 
Medication Log 
 
 
 
 
 
 
 
 
 
Pain assessmente 
 
 
() 
() 
 
() 
 
 
 
Photosf 
 
 
 
 
 
 
 
 
 
Nurse/investigator 
evaluationg 
 
 
  
  
 
  
 
  
 
Subject evaluationh 
 
 
 
 
 
 
 
 
 
Reason for termination 
 
 
 
 
 
 
 
 
 
AE/ADE/SAE/SADE/DD 
 
 
 
 
 
 
 
 
 
a Information will be collected at Day 3 only if the subject is still at the hospital and hasn´t been discharged 
b If the dressing is changed prior to post-op day 7 and outside scheduled visits, an unscheduled visit will be performed. 
c When possible, visit 6 should be scheduled to post-op day 7. When not possible due to weekends, post-op day 5 or post-op day 6 could be scheduled.  
d Dressing application/change/removal will be documented in the Dressing log. Ability to stay on (curl up at edges and partial/complete detachment) will also be 
collected  
e Pain assessment at dressing removal (VAS). If a dressing change is deemed necessary prior to visit 6, pain assessment should be collected 

CIP Amendment 
Document ID:  PD-521925 Rev: 00 
Title: CIP Amendment 01 
Page 5(6) 
Investigation Code MxB Po Ag 01Final Version 
CIP Approval date 2016-11-15 
Amendment Final Version 
Amendment Approval date 2016-11-21 
 
Document template: F-168 CIP Amendment 
Rev: 04 
 
 
f Photos should be taken at visit 2 ( at the incision before application of the dressing, at dressing after application of the dressing) and if the dressing is changed at visit 
3-6  ( at the dressing before removal of the dressing, at the incision after removal of the dressing and at dressing ( side facing the incision) , if signs of infection and if 
there in an unscheduled visit 
g The nurse or the investigator will give their assessment concerning the treatment 
h The nurse or the investigator will collect the subject´s experience via interview 
i Telephone Follow-Up 
 
CIP section: 4.1 Overall Design 
CIP page: 14 
From:  
This single center, open, non-controlled investigation will be conducted at one site in the US. 
Approximately 20 male or female subjects, 18 years or older, with a planned elective primary total 
hip or knee replacement will be recruited in this investigation. The primary purpose is to investigate 
if there is any skin damage under the dressing from operation day to last visit. Performance of the 
dressing as well as comfort, conformability, acceptability and pain at dressing removal will also be 
followed-up until post-op day 7. Subjects at site number 01 are usually sent home on post-op day 
two or three but this investigation will include a follow-up visit on post-op day 7 when the dressing 
is removed and the incision and incision site are inspected before termination. If it is not possible to 
schedule a visit at post-op day 7 due to weekends, it is ok to schedule a visit for post-op day 5 or 6. 
Post-op day 7 is however the day to strive for. 
 
To: 
This single center, open, non-controlled investigation will be conducted at one site in the US. 
Approximately 20 male or female subjects, 18 years or older, with a planned elective primary total 
hip or knee replacement will be recruited in this investigation. The primary purpose is to investigate 
if there is any skin damage under the dressing from operation day to last visit. Performance of the 
dressing as well as comfort, conformability, acceptability and pain at dressing removal will also be 
followed-up until post-op day 7. Subjects at site number 01 are usually sent home on post-op day 
one (1) or two (2). If the subject are sent home post-op day two (2) this investigation will include a 
telephone follow-up on post-op day two (2), clinic visit on post-op day three (3) and a follow-up visit 
on post-op day 7 when the dressing is removed and the incision and incision site are inspected 
before termination. If the dressing is changed prior to post-op day 7 and outside scheduled visits, 
an unscheduled visit will be performed. 
If it is not possible to schedule a visit at post-op day 7 due to weekends, it is ok to schedule a visit 
for post-op day 5 or 6. Post-op day 7 is however the day to strive for. 
 
CIP section: 4.1 Labelling 
CIP page: 18 
From: 
MHC will provide the investigational medical devices to the investigation site for free. Labelling of 
the investigational medical device will be performed in accordance with Good Manufacturing 
Practice (GMP). The labels will be produced in the local language and in accordance with local 
regulations for the US. The medical device will be marked with the following text: 
Mepilex Border Post-Op Ag 
Study Code: MxB Po Ag 01 

CIP Amendment 
Document ID:  PD-521925 Rev: 00 
Title: CIP Amendment 01 
Page 6(6) 
Investigation Code MxB Po Ag 01Final Version 
CIP Approval date 2016-11-15 
Amendment Final Version 
Amendment Approval date 2016-11-21 
 
Document template: F-168 CIP Amendment 
Rev: 04 
 
 
“CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational 
use." 
 
 
To: 
MHC will provide the investigational medical devices to the investigation site for free. Labelling of 
the investigational medical device will be performed in accordance with Good Manufacturing 
Practice (GMP). The labels will be produced in the local language and in accordance with local 
regulations for the US. The medical device will be marked with the following text: 
Mepilex Border Post-Op Ag 
Study Code: MxB Po Ag 01 
Investigational Device - Not for Resale 
 
REASON FOR MAKING THE AMENDMENT: 
Reason for making the amendment: 
According to standard of care on site no 01.  Subjects are usually sent home on post-op day one 
(1) and not post-op day three (3). The clinical investigation plan was updated to fit the standard of 
care on site no 01. 
Correcting typing errors: discrepancies between the label specification and labelling section in the 
clinical investigation plan. 
 
ACTIONS TO BE TAKEN: 
Investigator at the site will be provided with the amendment and signature will be collected. 
The Amendment will be sent to the IRB for approval according to local procedures. 
 
 

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CIP Amendment 
Document ID:  PD-522356 Rev: 00 
Title: CIP Non-substantial amendment 01 
Page 1(4) 
Investigation Code MxB Po Ag 01Final Version 
CIP Approval date 2016-11-15 
Amendment Final Version 
Amendment Approval date 2016-12-01 
 
Document template: F-168 CIP Amendment 
Rev: 04 
 
 
CLINICAL INVESTIGATION PLAN (CIP) Central AMENDMENT no 2 
Non Substantial 
  
INVESTIGATIONAL DEVICE:  
Mepilex Border Post-Op Ag 
INVESTIGATION TITLE:  
 
A single center, open, non-controlled investigation to evaluate the performance of a 
flexible, self-adherent absorbent silver dressing coated with a soft silicone layer 
after elective primary total hip or knee arthroplasty 
 
SITES AFFECTED BY THE AMENDMENT: 
The amendment affect all in the study 
 
 
 
 

CIP Amendment 
Document ID:  PD-522356 Rev: 00 
Title: CIP Non-substantial amendment 01 
Page 2(4) 
Investigation Code MxB Po Ag 01Final Version 
CIP Approval date 2016-11-15 
Amendment Final Version 
Amendment Approval date 2016-12-01 
 
Document template: F-168 CIP Amendment 
Rev: 04 
 
 
THE CLINICAL INVESTIGATION PLAN (CIP) IS TO BE AMENDED AS FOLLOWS: 
 
Section and page in the Clinical Investigation Plan: 
CIP section: Synopsis / Schedule of Assessment & 4.2.1 Schedule of Assessment 
CIP page: 5 & 15 
 
From:  
Day 
Baseline 
(screening 
visit) 
Day 0 
Day of 
surgery 
Day 1 
1st 
post -
op 
day 
Day  
2 
2nd 
post-
op 
daya 
Day  
2 
2nd post-
op  
Telephone 
Follow-Up i   
Day 3 
3rd 
post-
op 
daya 
Un-
scheduled 
visitb 
Day 
7 
7th 
post-
op 
day 
Term-
ination 
Visit window/days 
-21 to 0 
0 
0 
0 
0 
0 
0 
-2 to 
0c 
0 
Visit (number) 
1 
2 
3 
4 
4 
5 
Un-
scheduled 
6 
Term-
ination 
Inclusion/ Exclusion 
Criteria 
 
 
 
 
 
 
 
 
 
Informed Consent 
 
 
 
 
 
 
 
 
 
Subject ID 
 
 
 
 
 
 
 
 
 
Subject demography 
 
 
 
 
 
 
 
 
 
Skin status at incision 
site 
 
 
 
 
 
 
 
 
 
Medical /Surgical history 
 
 
 
 
 
 
 
 
 
Type of surgery  
 
 
 
 
 
 
 
 
 
Surgical incision 
condition 
 
 
 
 
 
 
 
 
 
Performance of the 
dressing 
 
 
 
 
 
 
 
 
 
Dressing logd 
 
 
() 
() 
 
() 
 
 
 
Medication Log 
 
 
 
 
 
 
 
 
 
Pain assessmente 
 
 
() 
() 
 
() 
 
 
 
Photosf 
 
 
 
 
 
 
 
 
 
Nurse/investigator 
evaluationg 
 
 
  
  
 
  
 
  
 
Subject evaluationh 
 
 
 
 
 
 
 
 
 
Reason for termination 
 
 
 
 
 
 
 
 
 
AE/ADE/SAE/SADE/DD 
 
 
 
 
 
 
 
 
 

CIP Amendment 
Document ID:  PD-522356 Rev: 00 
Title: CIP Non-substantial amendment 01 
Page 3(4) 
Investigation Code MxB Po Ag 01Final Version 
CIP Approval date 2016-11-15 
Amendment Final Version 
Amendment Approval date 2016-12-01 
 
Document template: F-168 CIP Amendment 
Rev: 04 
 
 
a Information will be collected at Day 3 only if the subject is still at the hospital and hasn´t been discharged 
b If the dressing is changed prior to post-op day 7 and outside scheduled visits, an unscheduled visit will be performed. 
c When possible, visit 6 should be scheduled to post-op day 7. When not possible due to weekends, post-op day 5 or post-op day 6 could be scheduled.  
d Dressing application/change/removal will be documented in the Dressing log. Ability to stay on (curl up at edges and partial/complete detachment) will also be 
collected  
e Pain assessment at dressing removal (VAS). If a dressing change is deemed necessary prior to visit 6, pain assessment should be collected 
f Photos should be taken at visit 2 ( at the incision before application of the dressing, at dressing after application of the dressing) and if the dressing is changed at visit 
3-6  ( at the dressing before removal of the dressing, at the incision after removal of the dressing and at dressing ( side facing the incision) , if signs of infection and if 
there in an unscheduled visit 
g The nurse or the investigator will give their assessment concerning the treatment 
h The nurse or the investigator will collect the subject´s experience via interview 
i Telephone Follow-Up 
 
To: 
Day 
Baseline 
(screening 
visit) 
Day 0 
Day of 
surgery 
Day 1 
1st 
post -
op 
day 
Day  
2 
2nd 
post-
op 
daya 
Day  
2 
2nd post-
op  
Telephone 
Follow-Up i   
Day 3 
3rd 
post-
op 
daya 
Un-
scheduled 
visitb 
Day 
7 
7th 
post-
op 
day 
Term-
ination 
Visit window/days 
-21 to 0 
0 
0 
0 
0 
0 
0 
-2 to 
0c 
0 
Visit (number) 
1 
2 
3 
4 
4 
5 
Un-
scheduled 
6 
Term-
ination 
Inclusion/ Exclusion 
Criteria 
 
 
 
 
 
 
 
 
 
Informed Consent 
 
 
 
 
 
 
 
 
 
Subject ID 
 
 
 
 
 
 
 
 
 
Subject demography 
 
 
 
 
 
 
 
 
 
Skin status at incision 
site 
 
 
 
 
 
 
 
 
 
Medical /Surgical history 
 
 
 
 
 
 
 
 
 
Type of surgery  
 
 
 
 
 
 
 
 
 
Surgical incision 
condition 
 
 
 
 
 
 
 
 
 
Performance of the 
dressing 
 
 
 
 
 
 
 
 
 
Dressing logd 
 
 
() 
() 
 
() 
 
 
 
Medication Log 
 
 
 
 
 
 
 
 
 
Pain assessmente 
 
 
() 
() 
 
() 
 
 
 
Photosf 
 
 
 
 
 
 
 
 
 
Nurse/investigator 
evaluationg 
 
 
  
  
 
  
 
  
 

CIP Amendment 
Document ID:  PD-522356 Rev: 00 
Title: CIP Non-substantial amendment 01 
Page 4(4) 
Investigation Code MxB Po Ag 01Final Version 
CIP Approval date 2016-11-15 
Amendment Final Version 
Amendment Approval date 2016-12-01 
 
Document template: F-168 CIP Amendment 
Rev: 04 
 
 
Day 
Baseline 
(screening 
visit) 
Day 0 
Day of 
surgery 
Day 1 
1st 
post -
op 
day 
Day  
2 
2nd 
post-
op 
daya 
Day  
2 
2nd post-
op  
Telephone 
Follow-Up i   
Day 3 
3rd 
post-
op 
daya 
Un-
scheduled 
visitb 
Day 
7 
7th 
post-
op 
day 
Term-
ination 
Subject evaluationh 
 
 
 
 
 
 
 
 
 
Reason for termination 
 
 
 
 
 
 
 
 
 
AE/ADE/SAE/SADE/DD 
 
 
 
 
 
 
 
 
 
a Information will be collected at Day 3 at the hospital or as outpatient visit  
b If the dressing is changed prior to post-op day 7 and outside scheduled visits, an unscheduled visit will be performed. 
c When possible, visit 6 should be scheduled to post-op day 7. When not possible due to weekends, post-op day 5 or post-op day 6 could be scheduled.  
d Dressing application/change/removal will be documented in the Dressing log. Ability to stay on (curl up at edges and partial/complete detachment) will also be 
collected  
e Pain assessment at dressing removal (VAS). If a dressing change is deemed necessary prior to visit 6, pain assessment should be collected 
f Photos should be taken at visit 2 ( at the incision before application of the dressing, at dressing after application of the dressing) and if the dressing is changed at visit 
3-6  ( at the dressing before removal of the dressing, at the incision after removal of the dressing and at dressing ( side facing the incision) , if signs of infection and if 
there in an unscheduled visit 
g The nurse or the investigator will give their assessment concerning the treatment 
h The nurse or the investigator will collect the subject´s experience via interview 
i Telephone Follow-Up 
 
REASON FOR MAKING THE AMENDMENT: 
Typing error, inconsistency between Overall Design and Scheduled of Assessment in the CIP 
body. 
 
 
 
ACTIONS TO BE TAKEN: 
Protocol updated with the corrections.