A Clinical Investigation to Study the Effect of Exufiber Ag+ and Other Gelling Fibre Dressings on Wound Exudate and Bioburden in Medium to High Exuding Wounds
Phase: NA
Conditions: Wounds and Injuries
Sponsor: Molnlycke Health Care AB

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 1(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
CLINICAL INVESTIGATION PLAN (CIP) 
INVESTIGATIONAL DEVICE: 
Exufiber Ag+ 
INVESTIGATION TITLE:  
A clinical investigation to study the effect of Exufiber Ag+ and other gelling fibre 
dressings on wound exudate and bioburden in medium to high exuding wound. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CO-ORDINATING INVESTIGATOR: 
Professor Robert S. Kirsner, M.D., PhD 
 
SPONSOR 
MÖLNLYCKE CLINICAL STUDY  
MANAGER: 
 
Channing Wood 
Mölnlycke Health Care 
P.O Box 130 80 
402 52 Gothenburg, Sweden 
Phone: +46 31 722 30 xx 
Fax: +46 31 722 34 91 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 2(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
 
 
 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 3(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
CLINICAL INVESTIGATION PLAN (CIP) SYNOPSIS 
 
INVESTIGATION TITLE:  
A clinical investigation to study the effect of Exufiber Ag+ and other gelling fibre 
dressings on wound exudate and bioburden in medium to high exuding wound. 
 
Objectives 
This investigation is undertaken to investigate the impact of Exufiber Ag+ and other gelling fibre 
dressings on handling exudate, changes in aerobic counts and microbial diversity of bioburden by 
collecting tissue and associated microbial virulence factors in the wound exudate by collecting 
wound exudate, in medium to high exuding wound. 
Primary objective 
• 
To evaluate reduction in exudate from baseline to last visit*. 
Secondary objective 
• 
To evaluate changes in bioburden from baseline to visit 3. 
• 
To evaluate the status of the wound and peri-wound skin from baseline to last visit* 
• 
To evaluate the handling and technical performance of the dressing from baseline to last 
visit* 
• 
To evaluate comfort, conformability and acceptability of the dressing from visit 3 to last 
visit* 
• 
To evaluate safety from baseline to last visit* 
*Last visit = Visit 5. Last visit occur earlier if the wound is dry or healed. 
** Distribution of patients included in the bioburden analysis can be found under 4.5.4 
For details please see section 4.5.2. 
Overall Design 
This is a non-randomised, prospective, multi-center, clinical investigation on medium to high 
exuding wound that will be conducted on approximately 105 subjects in US. 
An eligible subject is defined as a subject that fulfils all the inclusion and none of the exclusion 
criteria. Both inpatients and outpatients/subjects will be eligible. 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 4(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
The target subjects are male or female, 18 years or older who have a medium to high exuding 
wound. The objectives are to investigate the impact of Exufiber Ag+ and other gelling fibre 
dressings on handling wound exudate, bioburden and possible associated molecular biomarkers. 
Each subject will be evaluated during 5 visits, with a total treatment period of 4 weeks (28 days (± 
2 days)) or earlier if the wound is dry (see Table 1) or healed. 
Only one target wound per patient (indication specified in Appendix D, Instruction for use) will be 
included in this investigation.  
Dressing changes will be done every 7 days or earlier if needed according to instruction for use 
(see Appendix D) and the sites local routines. Dressing changes will be recorded in the “Dressing 
Log”. Dressing changes between the scheduled visits will be recorded on the “ Dressing Log” at 
the next scheduled visit. 
The subject will be assigned either to Exufiber®Ag+, Exufiber® or Aquacel™Ag Extra™ (For 
details see Figure 1). 
Study Period 
Estimated date of first subject enrolled Q2 2017  
Estimated date of last subject completed Q3 2019  
Estimated date of end of clinical investigation (database lock) Q3 2019  
Inclusion Criteria 
1. Subjects or subject’s legal authorized representative (LAR) able to read and sign the Patient 
Information and Consent Form  
2. Both gender ≥18 years old 
3. From Medium (defined as Wet specified in section 4.5.6) to High exuding (defined as Leaking 
specified in section 4.5.6) wound 
Exclusion Criteria 
1. Known allergy/hypersensitivity to any of the treatment dressings 
2. Pregnant/lactating females 
3. Subjects with a target wound that is ≤ 1 cm2 
4. Subjects with a target wound that is a full thickness burn 
5. Subjects with known immunodeficiency 
6. Subject taking systemic antibiotics for wound infection 
7. Subject were the target wound is located on an infected limb interfered by minimal blood flow 
(in the opinion of the investigator). 
8. Subject with a target wound with unexplored enteric fistula 
9. Subjects who, in the opinion of the investigator, will have problems following the protocol 
10. Subjects needing treatment with oxidizing agents such as hypochlorite solutions or hydrogen 
peroxide 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 5(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
11. Previously enrolled in the present investigation 
12. Inclusion in other ongoing investigations at present that would preclude the subject from 
participating in this investigation as judged by the investigator 
13. Involvement in the planning and conduct of the clinical investigation (applies to all Mölnlycke 
staff, investigational site staff and third party vendor) 
 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 6(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Schedule of Assessment 
Week number 
Visit 1 
(Baseline) 
Visit 1b  
Only 
applicable 
for site no 
01 
(4 days 
from 
baseline) 
Visit 2 
(7 days 
from 
baseline) 
Visit 3 
(14 days 
from 
baseline) 
Visit 4 
(21 days 
from 
baseline) 
Visit 5 
(28 days 
from 
baseline) 
Visit window 
NA 
± 1 days 
± 2 days 
± 2 days 
± 2 days 
± 2 days 
Informed consent 
√ 
 
 
 
 
 
Inclusion and exclusion 
criteria 
√ 
 
 
 
 
 
Subject demographics  
√ 
 
 
 
 
 
Vital Signs 
√ 
 
 
 
 
 
Type, location and 
duration of the wound 
√ 
 
 
 
 
 
Relevant Medical 
History a 
√ 
 
 
 
 
 
Relevant surgical 
history b 
√ 
 
 
 
 
 
Current wound 
treatment c 
√ 
 
 
 
 
 
Compression (if 
applicable) 
√ 
√ 
√ 
√ 
√ 
√ 
Evaluation of the 
exudate d 
√ 
√ 
√ 
√ 
√ 
√ 
Wound size 
measurement h 
√ 
√ 
√ 
√ 
√ 
√ 
Status of the wound and 
peri-wound evaluated 
by the study personnel 
√ 
√ 
√ 
√ 
√ 
√ 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 7(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Week number 
Visit 1 
(Baseline) 
Visit 1b  
Only 
applicable 
for site no 
01 
(4 days 
from 
baseline) 
Visit 2 
(7 days 
from 
baseline) 
Visit 3 
(14 days 
from 
baseline) 
Visit 4 
(21 days 
from 
baseline) 
Visit 5 
(28 days 
from 
baseline) 
Handling and technical 
performance of the 
dressing. 
√ 
 
√ 
√ 
√ 
√ 
Signs of clinical infection 
√ 
√ 
√ 
√ 
√ 
√ 
Photo e 
√ 
√ 
√ 
√ 
√ 
√ 
Tissue sampling f  
Only applicable for site no 
01 
√ 
√ 
√ 
√ 
 
 
Wound exudate 
sampling f 
Only applicable for site no 
01 
√ 
√ 
√ 
√ 
 
 
Subject evaluation 
 
 
√ 
√ 
√ 
√ 
Dressing application 
(First Visit) 
√ 
 
 
 
 
 
Dressing change 
 
√ i 
√ 
√ 
√ 
 
Dressing removal (Final 
Visit) 
 
 
 
 
 
√ 
Relevant concomitant 
medication 
√ 
√ 
√ 
√ 
√ 
√ 
AE/ADE/SAE/SADE/DD 
√ 
√ 
√ 
√ 
√ 
√ 
a) 
Relevant medical history specified in section 4.5.1. 
b) 
Relevant surgical history specified in section 4.5.1. 
c) 
Current wound treatment (name of the primary dressing and frequency of dressing changes/per week). 
d) 
Changes in exudate defined in details 4.5.6. 
e) 
PHOTOGRAPHS: Please see Appendix E for a detailed instruction of when photos should be taken. Please include measuring 
scale (ruler) with date, subject number and visit number and please respect the confidentiality of the subject by not including any 
personal numbers or identifying characteristic. 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 8(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
f) 
TISSUE and EXUDATE SAMPLING: Please see Appendix F for detail instruction how to collect tissue and exudate. Only 
applicable for site no 01 for subjects recruited before September 2018. 
g) 
Relevant concomitant medication specified in section 4.4. 
h) 
Wound size measurement before and after debridement (if applicable). 
i) 
Dressing change only applicable for site no 01 (included into the tissue and exudate sampling part in the clinical investigation). 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 9(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Investigational Devices 
Exufiber Ag+  
Exufiber Ag+ wound dressing is a sterile, soft and nonwoven pad. Exufiber Ag+ consists of highly 
absorbent and gel forming polyvinyl alcohol (PVA) nonwoven fibres. The nonwoven pad is coated 
with silver sulphate on both sides. The silver is released within the dressing in contact with fluid, 
and acts as a preservative in the dressing to inhibit or reduce microbial growth in the dressing. 
The investigational device fall under FDA-premarket notification K160379. The dressing is 
sterilized in EtO (ethylene oxide). 
For this clinical investigation, Exufiber Ag+ will be available in the following sizes:  
Dressing sizes 
Total silver content 
cm 
Inches 
mg 
5 x 5 
2x2 
5 
15 x15 
6x6 
45 
Manufacture registered trademark of Mölnlycke Health Care AB. 
Exufiber 
Exufiber is a sterile nonwoven dressing made from highly absorbent and gel forming polyvinyl 
alcohol fibres. Exufiber is available as pad. Exufiber wound dressing absorbs and retains wound 
exudate. It is transformed into a soft gel that facilitates moist wound healing and ease of removal 
during dressing change. The investigational device is exempt and fall under FDA regulation 
number 878.4018. The dressing is sterilized in EtO 
For this clinical investigation, Exufiber will be available in the following sizes: 
Dressing sizes 
cm 
Inches 
5 x 5 
2x2 
15 x15 
6x6 
Manufacture registered trademark of Mölnlycke Health Care AB. 
AquacelAg Extra 
Dressing with Silver and Strengthening Fibre is a one piece wound dressing comprised of two 
layers of soft, sterile non-woven material. The non-woven pads are comprised of Hydrofiber 
dressing and ionic silver stitch-bonded together with regenerated cellulose fibres and designed to 
provide additional absorbency and tensile strength properties. The investigational device fall 
under FDA-premarket notification K121275. 
Dressing sizes 
Total silver content 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 10(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
cm 
Inches 
Mg 
5 x 5 
2x2 
4.5 
15 x15 
6x6 
40.5 
Manufacture registered trademark of ConvaTec Inc. 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 11(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
TABLE OF CONTENTS 
1. INTRODUCTION .................................................................................................... 15 
2. OBJECTIVES ......................................................................................................... 16 
3. CLINICAL INVESTIGATOR(S) AND INVESTIGATION ADMINISTRATIVE 
STRUCTURE ................................................................................................................ 18 
3.1 
Staff at Investigation site(s) ................................................................................................................... 18 
3.2 
Mölnlycke Investigation Personnel ...................................................................................................... 18 
3.3 
Other Participants ..................................................................................................................................... 18 
4. INVESTIGATION PLAN AND PROCEDURES ...................................................... 19 
4.1 
Overall Design and Flow Chart .............................................................................................................. 19 
4.2 
Procedures and Assessments ............................................................................................................... 21 
4.2.1 
Schedule of Assessment ....................................................................................................................... 21 
4.2.2 
Inclusion Criteria ..................................................................................................................................... 24 
4.2.3 
Exclusion Criteria .................................................................................................................................... 24 
4.2.4 
Withdrawal of Subjects from Treatment or Assessment ................................................................... 24 
4.3 
Investigational Device .............................................................................................................................. 26 
4.3.1 
Summary description of the Investigational Device(s) ...................................................................... 26 
4.3.2 
Additional products ................................................................................................................................. 27 
4.3.3 
Labelling ................................................................................................................................................... 27 
4.3.4 
Accountability .......................................................................................................................................... 27 
4.3.5 
Storage conditions .................................................................................................................................. 28 
4.3.6 
Method of Assigning Subjects to Treatment Groups ......................................................................... 28 
4.4 
Concomitant Treatments ......................................................................................................................... 28 
4.5 
Performance and Safety .......................................................................................................................... 28 
4.5.1 
Subject Characteristics .......................................................................................................................... 28 
4.5.2 
Performance Measurements and Variables ....................................................................................... 30 
4.5.3 
Safety Measurements and Variables ................................................................................................... 33 
4.5.4 
Identification and quantification of microorganisms presents in the wound ................................... 35 
4.5.5 
Wound size measurement ..................................................................................................................... 35 
4.5.6 
Exudate Management ............................................................................................................................ 35 
4.5.7 
Signs of local infection split between acute and chronic wound ...................................................... 36 
4.5.8 
Anticipated ADEs .................................................................................................................................... 38 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 12(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
4.6 
Data Quality Assurance ........................................................................................................................... 38 
4.6.1 
Monitoring, Audits and Inspections ...................................................................................................... 38 
4.6.2 
Training of Staff ....................................................................................................................................... 39 
4.6.3 
Data Management .................................................................................................................................. 39 
4.7 
Statistical Methods and Determination of Sample Size .................................................................. 40 
4.7.1 
Statistical Evaluation .............................................................................................................................. 40 
4.7.2 
Performance Analysis ............................................................................................................................ 42 
4.7.3 
Determination of Sample Size .............................................................................................................. 42 
4.8 
Changes to the Clinical Investigation Plan ........................................................................................ 42 
5. STATEMENTS OF COMPLIANCE ......................................................................... 42 
5.1 
IRB ................................................................................................................................................................ 42 
5.1.1 
IRB review ................................................................................................................................................ 42 
5.1.2 
Ethical Conduct of the Investigation ..................................................................................................... 43 
5.1.3 
Patient Information and Consent Form ................................................................................................ 43 
5.2 
Regulatory and standards ...................................................................................................................... 43 
5.2.1 
Regulatory review ................................................................................................................................... 43 
5.2.2 
Standards and other ............................................................................................................................... 44 
5.2.3 
Subject Data Protection ......................................................................................................................... 44 
5.3 
SUBJECT PROTECTION PROCEDURES ............................................................................................. 44 
5.3.1 
Procedures in Case of Medical Emergency ........................................................................................ 44 
5.3.2 
Insurance ................................................................................................................................................. 44 
6. INVESTIGATION TIMETABLE AND TERMINATION ............................................ 44 
7. PUBLICATION ....................................................................................................... 44 
7.1 
Publication policy ..................................................................................................................................... 44 
8. LITERATURE REVIEW AND REFERENCES ........................................................ 45 
9. DEFINITIONS AND PROCEDURES FOR REPORTING OF ADVERSE EVENT, 
ADVERSE DEVICE EFFECT, SERIOUS ADVERSE EVENT, SERIOUS ADVERSE 
DEVICE EFFECT AND DEVICE DEFICIENCY ............................................................. 47 
 
TABLE OF FIGURES 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 13(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Figure 1 Dressing distribution flow chart .................................................................................... 19 
Figure 2 Measure wound size .................................................................................................... 35 
Figure 3 Local infection, definition for acute and chronic wounds 8 ............................................ 36 
TABLE 
Table 1 Evaluate changes in exudate status. 1 ........................................................................... 35 
 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 14(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
LIST OF APPENDICES 
Appendix A  F-449 Clinical Investigation Plan Appendix A, Core Signatures 
 
F-583 Clinical Investigation Plan Principal Investigator Signature 
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 Photograph Manual 
Appendix F Tissue and Exudate Sampling 
LIST OF ABBREVIATIONS  
ADE 
Adverse Device Effect 
AE 
Adverse Event 
CA 
Competent Authority 
CFU 
Colony Forming Units 
eCRF 
Electronic Case Report Form 
DD 
Device Deficiency 
EC 
Ethics Committee 
GCP 
Good Clinical Practice 
IRB 
Institutional Review Board 
PCR  
Polymerase Chain Reaction  
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 15(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
1. INTRODUCTION 
Non-healing wounds are a significant problem for health-care systems worldwide. The presence 
of microorganisms in the wound, referred to as bioburden, negatively interferes with the healing 
process1. 
Assessing the bioburden in slow healing wounds relies on the assessment of clinical signs of 
infection, which in many cases is a very blunt tool to predict the wound bioburden in patients2. 
While many dressings are designed or marketed to address the bioburden in wounds and 
suggest the reduction of bioburden, very few methods are available to monitor this performance 
of a wound dressing in patients. 
While biopsies, the golden standard, provide an accurate picture of CFU counts even in the 
deeper layer of skin tissue, they are invasive and offer only a small window into the total surface 
area of wounds. Some other methods commonly used, such as swabbing provide a snapshot of 
the bioburden over the whole surface area of the wound but fail to provide an accurate 
measurement of the total bioburden deeper in the tissue. 
Some attempts have been made to identify chemical biomarkers to assess the bioburden status 
of the wound in an attempt to make the link between healing and non-healing wounds3. 
To correlate molecular biomarkers with overall reduction of the bioburden in the wound is difficult 
due to the time dependent appearance of biomarkers as well as their selectivity for certain 
strains. 16S DNA sequencing provides as fast and detailed assessment of the wound microbiota 
and the relative amount of the various present species4. Viability PCR or Pre-rRNA analysis 
(MVT) allow a dead or alive distinction9. 
Culture testing is not as sensitive as molecular testing, so culturing often fails to detect bacteria, 
even bacteria that are present in a high relative abundance. Bacteria that are present in high 
relative abundance are likely of high clinical relevance, including the bacteria that are not 
detected by culture. It also allows an absolute quantification of the CFU count of the test sample5. 
Wound exudate samples can be used to identify molecular biomarkers such as enzymes, 
cytokines and metabolites. The significance of the appearance and relative fold change of such 
biomarkers in combination with the change of bioburden of the wound is investigated and could 
provide crucial information to predict bioburden in wounds. 
Wounds that produce an excessive amount of exudate is in an, inflammatory state. By reducing 
exudate the conditions for bacterial growth become less optimal. Gelling fibre dressings are 
developed to absorb and retain large amount of exudate to support an optimal wound healing 
process. Gelling fibre dressings with additional silver ions have in vitro models shown to decrease 
the number of microorganisms. 
Delayed healing often defined as clinical signs of infection (exudate, pain, discoloration, odour)6. 
Infected wounds are likely to be more painful and associated with high exudate levels which can 
increase the number of dressing changes required. The negative effect on excess exudate on 
wound healing can result in delayed healing, maceration of peri-wound skin and embarrassing 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 16(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
leakage for the patient. It is important that modern wound dressing can maintain moisture 
balance by absorbing excess exudate and preventing the wound drying out, in addition to being 
able to afford bacterial barrier properties in the wound are risk of infection, when required7. 
Majority of the silver dressing studies have included endpoints related to healing, however more 
appropriate endpoints for silver dressing may related to measure microbial burden or assessment 
of clinic indicators of infection8. 
The current golden standard of antimicrobial gelling fibre dressings is today Aquacel Ag and its 
further developed range of products such as Aquacel Ag Extra and Aquacel Ag+ Extra (not on the 
US only EU market). A new antimicrobial gelling fibre dressing (Exufiber Ag+) has been 
developed and is 510(k) cleared for sales in the United States. 
Exufiber Ag+ has been shown to have a higher retention capacity than Aquacel Ag Extra. The 
non-silver version (Exufiber) has been on the market for a couple of years and both clinical 
investigations and customer feedback have confirmed the dressings high performance in exudate 
management. Two in vivo studies on pigs where the antimicrobial properties of Exufiber Ag+ 
were compared to both Exufiber and Aquacel Ag+ Extra have been performed. The results from 
these studies showed that Exufiber Ag+ was the most efficient treatment at reducing bioburden 
measured as established biofilms of MRSA and Pseudomonas aeruginosa10,Error! Reference source not 
found.. 
Our study purpose is to investigate the impact of Exufiber Ag+ and other gelling fibre dressing on 
handling wound exudate, bioburden and possible associated molecular biomarkers. The study is 
expected to provide a lot of important knowledge by combining advanced microbial detection 
techniques with dressing performance and clinical outcomes.  
2. OBJECTIVES 
This investigation is undertaken to investigate the impact of Exufiber Ag+ and other gelling fibre 
dressings on handling exudate, changes in aerobic counts and microbial diversity of bioburden by 
collecting tissue and associated microbial virulence factors in the wound exudate by collecting 
wound exudate, in medium to high exuding wound. 
Primary objective 
• 
To evaluate reduction in exudate from baseline to last visit*. 
Secondary objective 
• 
To evaluate changes in bioburden from baseline to visit 3. 
• 
To evaluate the status of the wound and peri-wound skin from baseline to last visit* 
• 
To evaluate the handling and technical performance of the dressing from baseline to last 
visit* 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 17(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
• 
To evaluate comfort, conformability and acceptability of the dressing from visit 3 to last 
visit* 
• 
To evaluate safety from baseline to last visit* 
*Last visit = Visit 5. Last visit occur earlier if the wound is dry or healed. 
** Distribution of patients included in the bioburden analysis can be found under 4.5.4 
For details please see section 4.5.2. 
 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 18(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
3. CLINICAL INVESTIGATOR(S) AND INVESTIGATION 
ADMINISTRATIVE STRUCTURE 
3.1 Staff at Investigation site(s) 
Name and addresses of principal investigators are listed in Appendix A 
3.2 Mölnlycke Investigation Personnel 
Role in the investigation 
Name 
Contact information 
Clinical Study Manager 
Author of the CIP 
Tina Kjellén 
Mölnlycke Health Care AB 
Byfogdegatan 1 
SE-415 05 Göteborg, SWEDEN 
Phone: +46 31 722 30 00 
E-mail: tina.kjellen@molnlycke.com 
Clinical Study Manager 
Responsible for the clinical 
investigation 
Channing Wood 
Molnlycke Health Care US, LLC 
5550 Peachtree Parkway 
Suite 500 
Norcross, GA 30092 
USA 
Phone: +1 4703750186 
E-mail: channing.wood@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 
Ann-Sofie 
Svensson 
 
Mölnlycke Health Care AB 
Byfogdegatan 1 
SE-415 05 Göteborg, SWEDEN 
Phone: +46 31 722 30 00 
ann-sofie.svensson@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 
Supplier of the electronic data 
capture ( EDC) system 
Pharma Consulting Group AB 
Kungsängsvägen 19  
SE-753 23 Uppsala 
Sweden 
Phone: +46 18 430 3100 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 19(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Biostatistician  
Statistiska Konsultgruppen 
Nils-Gunnar Pehrsson  
Stigbergsliden 5 
SE-414 63 Göteborg 
CRO 
Peachtree BioResearch Solutions, Inc. 
4985 Lower Roswell Rd., Bldg. 100 
Marietta, GA 30068 
4. INVESTIGATION PLAN AND PROCEDURES 
4.1 Overall Design and Flow Chart 
This non-randomised, prospective, multi-center, clinical investigation on medium to high 
exuding wound, will be conducted at up to 15 sites on approximately 105  subjects in US. 
An eligible subject is defined as a subject that fulfils all the inclusion and none of the 
exclusion criteria. Both inpatient and outpatient/subjects will be eligible. The target 
subject are male or female, 18 year or older who have a medium to high exuding wound. 
The objectives are to investigate the impact of Exufiber Ag+ and other gelling fibre 
dressing on handling wound exudate, bioburden and possible associated molecular 
biomarkers 
Each subject will be evaluated during 5 visits, with a total treatment period of 4 weeks (28 
days (± 2 days)) or earlier if the wound is dry (see Table 1) or healed. 
Only one target wound per patient (indication specified in Appendix D, Instruction for use) 
will be included in this investigation.  
The subject will be assigned either to Exufiber Ag+, Exufiber or Aquacel Ag Extra 
according to Figure 1 Dressing distribution flow chart. 
Dressing change will be done every 7 days or earlier if needed according to instruction for 
use (see Appendix D) and the sites local routines. Dressing changes will be recorded in 
the “Dressing Log”. Dressing changes between the scheduled visits will be recorded in 
the “ Dressing Log” at the next scheduled visit. 
Secondary dressing will be chosen according to local routine. 
Figure 1 Dressing distribution flow chart 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 20(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
 
 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 21(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
4.2 Procedures and Assessments 
4.2.1 Schedule of Assessment 
Week number 
Visit 1 
(Baseline) 
Visit 1b  
Only 
applicable 
for site no 
01 
(4 days 
from 
baseline) 
Visit 2 
(7 days 
from 
baseline) 
Visit 3 
(14 days 
from 
baseline) 
Visit 4 
(21 days 
from 
baseline) 
Visit 5 
(28 days 
from 
baseline) 
Visit window 
NA 
± 1 days 
± 2 days 
± 2 days 
± 2 days 
± 2 days 
Informed consent 
√ 
 
 
 
 
 
Inclusion and exclusion 
criteria 
√ 
 
 
 
 
 
Subject demographics  
√ 
 
 
 
 
 
Vital Signs 
√ 
 
 
 
 
 
Type, location and 
duration of the wound 
√ 
 
 
 
 
 
Relevant Medical 
History a 
√ 
 
 
 
 
 
Relevant surgical 
history b 
√ 
 
 
 
 
 
Current wound 
treatment c 
√ 
 
 
 
 
 
Compression (if 
applicable) 
√ 
√ 
√ 
√ 
√ 
√ 
Evaluation of the 
exudate d 
√ 
√ 
√ 
√ 
√ 
√ 
Wound size 
measurement h 
√ 
√ 
√ 
√ 
√ 
√ 
Status of the wound and 
peri-wound evaluated 
√ 
√ 
√ 
√ 
√ 
√ 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 22(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Week number 
Visit 1 
(Baseline) 
Visit 1b  
Only 
applicable 
for site no 
01 
(4 days 
from 
baseline) 
Visit 2 
(7 days 
from 
baseline) 
Visit 3 
(14 days 
from 
baseline) 
Visit 4 
(21 days 
from 
baseline) 
Visit 5 
(28 days 
from 
baseline) 
by the study personnel 
Handling and technical 
performance of the 
dressing. 
√ 
 
√ 
√ 
√ 
√ 
Signs of clinical infection 
√ 
√ 
√ 
√ 
√ 
√ 
Photo e 
√ 
√ 
√ 
√ 
√ 
√ 
Tissue sampling f  
Only applicable for site no 
01 
√ 
√ 
√ 
√ 
 
 
Wound exudate 
sampling f 
Only applicable for site no 
01 
√ 
√ 
√ 
√ 
 
 
Subject evaluation 
 
 
√ 
√ 
√ 
√ 
Dressing application 
(First Visit) 
√ 
 
 
 
 
 
Dressing change 
 
√ i 
√ 
√ 
√ 
 
Dressing removal (Final 
Visit) 
 
 
 
 
 
√ 
Relevant concomitant 
medication 
√ 
√ 
√ 
√ 
√ 
√ 
AE/ADE/SAE/SADE/DD 
√ 
√ 
√ 
√ 
√ 
√ 
a) 
Relevant medical history specified in section 4.5.1. 
b) 
Relevant surgical history specified in section 4.5.1. 
c) 
Current wound treatment (name of the primary dressing and frequency of dressing changes/per week). 
d) 
Changes in exudate defined in details 4.5.6. 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 23(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
e) 
PHOTOGRAPHS: Please see Appendix E for a detailed instruction of when photos should be taken. Please include measuring 
scale (ruler) with date, subject number and visit number and please respect the confidentiality of the subject by not including any 
personal numbers or identifying characteristic. 
f) 
TISSUE and EXUDATE SAMPLING: Please see Appendix F for detail instruction how to collect tissue and exudate. Only 
applicable for site no 01 for subjects recruited before September 2018. 
g) 
Relevant concomitant medication specified in section 4.4. 
h) 
Wound size measurement before and after debridement (if applicable). 
i) 
Dressing change only applicable for site no 01 (included into the tissue and exudate sampling part in the clinical investigation). 
 
 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 24(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
4.2.2 Inclusion Criteria 
For inclusion in the investigation, the subjects must fulfil all of the below criteria prior to 
enrolment: 
1. Signed Informed Consent Form 
2. Both gender ≥18 years old 
3. From Medium (defined as Wet specified in section 4.5.6) to High exuding (defined as Leaking 
specified in section 4.5.6) wound 
4.2.3 Exclusion Criteria 
Subjects who meet any of the below criteria will be excluded from the investigation 
1. Known allergy/hypersensitivity to any of the treatment dressings 
2. Pregnant/lactating females 
3. Subjects with a target wound that is ≤ 1 cm2 
4. Subjects with a target wound that is a full thickness burn 
5. Subjects with known immunodeficiency 
6. Subject taking systemic antibiotics for wound infection 
7. Subject were the target wound is located on an infected limb interfered by minimal blood flow 
(in the opinion of the investigator). 
8. Subject with a target wound with unexplored enteric fistula 
9. Subjects who, in the opinion of the investigator, will have problems following the protocol 
10. Subjects needing treatment with oxidizing agents such as hypochlorite solutions or hydrogen 
peroxide 
11. Previously enrolled in the present investigation 
12. Inclusion in other ongoing investigations at present that would preclude the subject from 
participating in this investigation as judged by the investigator 
13. Involvement in the planning and conduct of the clinical investigation (applies to all Mölnlycke 
staff, investigational site staff and third party vendor) 
4.2.4 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 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 25(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 26(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
4.3 Investigational Device 
4.3.1 Summary description of the Investigational Device(s) 
Exufiber Ag+  
Exufiber Ag+ wound dressing is a sterile, soft and nonwoven pad. Exufiber Ag+ consists of highly 
absorbent and gel forming polyvinyl alcohol (PVA) nonwoven fibres. The nonwoven pad is coated 
with silver sulphate on both sides. The silver is released within the dressing in contact with fluid, 
and acts as a preservative in the dressing to inhibit or reduce microbial growth in the dressing. 
The investigational device fall under FDA-premarket notification K160379. The dressing is 
sterilized in EtO (ethylene oxide).  
For this clinical investigation, Exufiber Ag+ will be available in the following size:  
Dressing sizes 
Total silver content 
cm 
Inches 
mg 
5x5 
2x2 
5 
15x15 
6x6 
45 
Manufacture registered trademark of Mölnlycke Health Care AB. 
Exufiber 
Exufiber is a sterile nonwoven dressing made from highly absorbent and gel forming polyvinyl 
alcohol fibres. Exufiber is available as pad. Exufiber wound dressing absorbs and retains wound 
exudate. It is transformed into a soft gel that facilitates moist wound healing and ease of removal 
during dressing change. The investigational device is exempt and fall under FDA regulation 
number 878.4018 The dressing is sterilized in EtO. 
For this clinical investigation, Exufiber will be available in the following size: 
Dressing sizes 
cm 
Inches 
5x5 
2x2 
15x15 
6x6 
Manufacture registered trademark of Mölnlycke Health Care AB. 
Aquacel Ag Extra 
Dressing with Silver and Strengthening Fibre is a one piece wound dressing comprised of two 
layers of soft, sterile non-woven material. The non-woven pads are comprised of Hydrofiber 
dressing and ionic silver stitch bonded together with regenerated cellulose fibres and designed to 
provide additional absorbency and tensile strength properties. The investigational device fall 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 27(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
under FDA-premarket notification K121275. The dressing is sterilized by radiation. 
For this clinical investigation, Aquacel Ag Extra will be available in the following size: 
Dressing sizes 
Total silver content 
cm 
Inches 
mg 
5x5 
2x2 
4.5 
15x15 
4x4 
40.5 
Manufacture registered trademark of ConvaTec Inc. 
For more information regarding the dressings, instructions for use and precautions see Appendix 
D, Instruction for use.  
4.3.2 Additional products 
All additional products must be record in the “Dressing Log”. The secondary dressing will be 
chosen according to local routine. 
4.3.3 Labelling 
Mölnlycke will provide the investigational devices to the investigation site for free, the study 
dressings should only be used within the clinical investigation. 
The Exufiber Ag+ is a 510(k) cleared device the additional labels are just there to assist the study 
site in identifying investigational device.  
Exufiber and Aquacel Ag Extra will not be labelled with an extra label. 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 Exufiber Ag+ will be labelled with the following text: 
Exufiber Ag+ 
Study code: Exufiber Ag+ 01 
Investigational device – Not for Resale 
4.3.4 Accountability 
The investigational device dressings will not be distributed to the investigation site until all 
agreements between the investigator and Mölnlycke are finalized and IRB approval has been 
obtained. All investigational device dressings must be kept in a secure place under appropriate 
storage conditions. 
Use of Exufiber Ag +, Exufiber, Aquacel Ag Extra and the secondary dressing will be recorded in 
the “Dressing Log” and will be reviewed at each monitoring visit. The investigational device may 
only be used in this clinical investigation and according to the CIP. 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 28(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
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 Mölnlycke for destruction, or destroyed 
locally upon agreement with and approval from Mölnlycke. 
Applicable documents are the “Certificate of Delivery of Investigational Device/Material” and the 
“Certificate of Return and Destruction of Investigation Product”. 
4.3.5 Storage conditions 
Investigational device dressings are to be handled and stored safely (locked place), properly and 
in agreement with the given storage instructions. 
A description of the appropriate storage and shipment conditions are specified on the 
investigational device label and in the instructions for use documentation (IFU), Appendix D. 
 
4.3.6 Method of Assigning Subjects to Treatment Groups 
Subjects will be assigned according to section 4.1. The first eligible 50 subjects will be assigned 
by the investigator to Exufiber Ag+, Subjects 51 to  65  will be assigned to Exufiber, Subjects 66 
to 85   will be assigned to Aquacel Ag Extra and recorded in the eCRF. Subjects 86 to 105 will be 
assigned to Exufiber Ag+ on eligible pressure ulcer subjects. Mölnlycke or delegate will notify the 
study investigator when each treatment group has been fully enrolled. Each treatment group may 
be adjusted due to enrolment by approximately 20%.  
The secondary dressing will be chosen according to local routine. 
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. 
4.4 Concomitant Treatments 
Medication, which is considered necessary for the subject’s safety and well-being, may be given 
at the discretion of the investigator. Except the study dressings, usage of other antimicrobial 
dressings or antimicrobial topical agents on the target wound during the study is not allowed. 
All relevant concomitant medication that may have an impact of the wound condition, safety for 
the subject or may affect the evaluation of dressings performance as justified by the investigator 
should be recorded in the appropriate section of the electronic Case Report Form (eCRF). 
4.5 Performance and Safety 
4.5.1 Subject Characteristics 
Date of birth 
DD/MMM/YYYY 
Gender 
Male/Female 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 29(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Vital signs 
Height (cm/feet and inches) 
Weight (kg/pounds) 
BMI 
Relevant Medical 
History 
Relevant such as diabetes, 
arterial disease lower leg, 
anemia, cardio-vascular 
disease, thrombosis, that 
may affect the evaluation of 
dressings performance  
Medical condition 
Date of initial diagnosis 
Past/current 
Ongoing medication 
Relevant Surgical 
History 
Relevant such as varicose 
vein, amputation defined as 
surgery that may affect the 
evaluation of dressings 
performance. 
Surgical procedure 
Date of surgical procedure 
Past/current 
Ongoing medication 
Type of wound and 
location of the 
wound 
Venous leg ulcer 
Arterial leg ulcer 
Mixed ethology 
Pressure ulcers (partial) 
Diabetic foot ulcer 
Traumatic wounds 
Partial thickness burns (second degree) 
Donor site 
Malignant wounds 
Duration of wound  
< 1week 
≥ 1 week to <6 weeks 
≥ 6 weeks to <12 month 
≥12 month 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 30(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Current wound 
treatment 
Primary dressing (Y/N) 
Name of the current primary dressing 
Frequency of dressing change/per week 
Secondary dressing (Y/N) 
Name of the current secondary dressing 
4.5.2 Performance Measurements and Variables 
Primary objective 
Primary outcome variable 
To evaluate changes 
in exudate status 
(see Table 1) from 
baseline to last visit. 
Dry and healed wounds 
counts as successful 
wound 
Dry  
 
 
Moist 
 
 
Wet 
 
 
Saturated 
 
 
Leaking 
 
Secondary 
objective 
Secondary outcome variable 
To evaluate the 
status of the wound 
and peri-wound skin 
from baseline to last 
visit (by visit )  
Status of the wound and peri-wound skin evaluated by study 
personnel  
Exudate nature (Serous/Serosanguinous/Sanguinous/Purulent/NA) 
Malodour (None, Slight, Moderate, Strong) 
Redness/Irritation under the Primary dressing (Y/N)  
Redness/irritation outside the Primary dressing (Y/N) 
Maceration under the Primary dressing (Y/N)  
Maceration outside the Primary dressing (Y/N)  
Wound size (as described in section 4.5.5)  
Tissue type of the wound bed: Necrotic%, Sloughy%, Granulation% 
Epithelization%, Other if applicable in % 
Wound status  
(Stagnated, Aggravated, Same as baseline, Improved, Healed) 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 31(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Secondary 
objective 
Secondary outcome variable 
To evaluate the 
handling and 
technical 
performance of the 
dressing from 
baseline to last visit 
(by visit ) 
Investigator and Nurse Evaluation 
Primary dressing, ease of application 
(Very Poor/Poor/Good/Very Good/NA) 
Primary dressing, ease of removal without moistening the dressing 
(Very Poor/Poor/Good/Very Good/NA) 
Primary dressing, can be removed in one piece 
(Very Poor/ Poor/ Good/ Very Good/ NA) 
Primary dressing, adherent to the wound bed (Y/N). If Yes, specify: 
 
Primary dressing, ability to rehydrate 
 
(Very Poor/ Poor/ Good/Very Good/NA) 
 
Primary dressing, ease of removal after moistening 
 
the dressing 
 
(Very Poor/ Poor/ Good/Very Good/NA) 
Primary dressing, residuals of the dressing material in the wound or 
surrounding skin 
(Very Poor/Poor/ Good/ Very Good/NA) 
Primary dressing, ability to absorb exudate 
(Very Poor/Poor/Good/Very Good/NA) 
Primary dressing, ability to absorb blood 
(Very Poor/Poor/Good/Very Good/NA) 
Primary dressing, ability to retain exudate  
(Very Poor/Poor/Good/Very Good/NA) 
Primary dressing, ability to retain slough  
(Very Poor/Poor/Good/Very Good/NA) 
Primary dressing, ability to clean the wound bed (remove blood, pus, 
slough etc.) 
(Very Poor/Poor/Good/Very Good/NA) 
Primary dressing, ability to retain the soft and gelling properties  
(Very Poor/Poor/Good/Very Good/NA) 
Primary dressing, ability to retain a balanced moist environment in 
the wound 
(Very Poor/Poor/Good/Very Good/NA) 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 32(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Secondary 
objective 
Secondary outcome variable 
Primary dressing conforms to the wound contours 
(Very Poor/Poor/Good/Very Good/NA) 
Primary dressing, overall experience  
(Very Poor/ Poor/ Good/Very Good/NA) 
To evaluate the 
dressing stay on 
ability and 
preparation of the 
skin from baseline 
to last visit (by visit) 
Compression therapy (Y/N/NA) 
Cleansing (Y/N/NA) 
Debridement (Y/N/NA) 
Frequency of dressing change? 
If Primary dressing is change due to leaking Y/N if yes, please 
specify  
- 
Dressing, is full 
- 
Dressing shrinks and doesn’t fill up the wound 
- 
Other 
To evaluate 
comfort, 
conformability and 
acceptability of the 
dressing from visit 3 
to last visit (by visit) 
from a subject view 
Subject Evaluation  
Comfort when wearing the primary dressing  
(Very Poor/Poor/Good/Very Good/NA) 
Ease of mobility while wearing the primary dressing  
(Very Poor/Poor/Good/Very Good/NA) 
Primary dressing remained in place  
(Very Poor/Poor/Good/Very Good/NA) 
Stinging or burning while wearing the primary dressing 
(Y/N/NA) 
Primary dressing, overall experience 
(Very Poor/Poor/Good/Very Good/NA) 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 33(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Secondary 
objective 
Secondary outcome variable 
To evaluate the 
bioburden from 
baseline to visit 3 
Microbial detection  
Change in the aerobic counts (Log CFU/cm2) and microbial diversity 
from baseline to visit 1b (4 days after baseline) 
Change in the aerobic counts (Log CFU/cm2) and microbial diversity 
from baseline to visit 2 (7 days after baseline) 
Change in the aerobic counts (Log CFU/cm2) and microbial diversity 
from baseline to visit 3 (14 days after baseline) 
4.5.3 Safety Measurements and Variables 
To evaluate safety 
from baseline to 
last visit 
 
Signs of clinical infection (Figure 3) 
Acute wounds 
Classical signs (new and increasing pain, erythema, local warmth, 
swelling, purulent discharge) (Y/N) 
Pyrexia (Y/N) 
Delayed or stalled healing (Y/N) 
Abscess (Y/N) 
Malodour (Y/N) 
Chronic wounds 
New, increased or altered pain (Y/N) 
Delayed (or stalled) healing (Y/N) 
Periwound oedema (Y/N) 
Bleeding or friable (easily damaged) granulation tissue (Y/N) 
Distinctive malodour or change in odour (Y/N) 
Wound bed discolouration (Y/N) 
Increased, altered or purulent exudate (Y/N) 
Induration (hardening of a tissue, particularly the skin, caused by 
inflammation) (Y/N) 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 34(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Pocketing-granulation tissue does not grow in a uniform manner 
across the entire wound, pockets can harbour bacteria (Y/N) 
Bridging-presence of strands of tissue across the wound bed (Y/N) 
Adverse Event (AE)/Adverse Device Effect (ADE), Serious Adverse 
Event (SAE)/Serious Adverse Device Effect (SADE), Device 
deficiency (DD) 
 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 35(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
4.5.4 Identification and quantification of microorganisms presents in the wound  
This section is only applicable for site no 01 (only subjects enrolled before September 
2018) since they are the only site collecting tissue and exudate. 
Evaluation of antimicrobial activity of Exufiber Ag+ and Exufiber on wound bioburden by collection 
of tissue and exudate (specified in Appendix F). Following analysis will be performed on 
approximately 30 subjects, equally distributed between Exufiber Ag+ and Exufiber. 
✓ overall quantification of microbial counts by traditional culturing under aerobic conditions 
✓ identification of bacteria/fungi by Next Generation Sequencing (16S rRNA for bacteria, 
ITS1 or ITS2 for fungi)  
✓ evaluate inflammatory biomarkers and virulence factors via collecting wound exudate 
4.5.5 Wound size measurement  
Figure 2 Measure wound size 
 
Wound size will be measured according to schedule of assessment (4.2.1), if debridement, 
wound size will be measured before and after debridement, record in inches/mm. 
4.5.6 Exudate Management 
Table 1 Evaluate changes in exudate status. 12 
Indicators 
Status 
Wound bed 
Dressing 
Surrounding skin 
Dry 
Wound bed is dry; 
there is no visible 
moisture 
Primary dressing is unmarked; 
dressing may be adherent to wound 
Skin may be scaly, 
atrophic, hyperkeratotic 
Moist 
Small amounts of fluid 
are visible when 
dressing is removed; 
wound bed may 
appear glossy 
Primary dressing may be lightly 
marked; dressing change frequency is 
appropriate 
Skin is likely to be intact, 
hydrated, no lesions 
Wet 
Small amounts of fluid 
are visible when the 
dressing is removed 
Primary dressing is extensively 
marked, but strikethrough does not 
Initial fragmented areas 
of maceration may be 
apparent 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 36(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
occur; appropriate dressing change 
frequency 
Saturated 
Free fluid is visible 
when the dressing is 
removed 
Primary dressing is wet and 
strikethrough occurs; dressing change 
is required more frequently than usual 
Peri-wound skin is likely 
to be macerated or 
denuded with extensive 
involvement 
Leaking Free fluid is visible 
when the dressing is 
removed 
Dressings are saturated and exudate 
is escaping from primary and 
secondary dressings onto clothes or 
beyond; dressing change is required 
much more frequently than usual 
Peri wound skin is likely 
to be macerated or 
denuded with extensive 
involvement 
4.5.7 Signs of local infection split between acute and chronic wound  
Figure 3 Local infection, definition for acute and chronic wounds 8 
Signs and symptoms of localised infection in wounds. 
ACUTE WOUNDS e.g. surgical or traumatic wounds, burns 
• 
Classical signs and symptoms:  
 
new or increasing pain  
 
erythema  
 
local warmth  
 
swelling  
 
purulent discharge 
• 
Pyrexia 
• 
Delayed or stalled healing 
• 
Abscess 
• 
Malodour 
CHRONIC WOUNDS e.g. diabetic foot ulcers, venous leg ulcers, arterial leg/foot ulcers, 
pressure ulcers 
• 
New, increased or altered pain 
• 
Delayed (or stalled) healing 
• 
Periwound oedema 
• 
Bleeding or friable (easily damaged) granulation tissue  
• 
Distinctive malodour or change in odour 
• 
Wound bed discolouration 
• 
Increased, altered or purulent exudate 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 37(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
• 
Induration (hardening of a tissue, particularly the skin, caused by inflammation) 
• 
Pocketing-granulation tissue does not grow in a uniform manner across the entire 
wound, pockets can harbour bacteria 
• 
Bridging-presence of strands of tissue across the wound bed 
 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 38(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
4.5.8 Anticipated ADEs  
The following possible clinical outcomes have been identified as anticipated adverse device 
effects in connection to the risks evaluated in the Product Risk Management Record for: 
Exufiber Ag+ 
• 
Maceration 
• 
Prolonged wound healing 
• 
Leakage leading to cross contamination or infection 
• 
Infection due to contamination 
• 
Bacterial growth/Infection 
• 
Discolouration  
• 
Local allergic reaction  
• 
Sensitisation, cytotox, skin irritation 
• 
Selection for resistant microorganisms 
• 
Anaemia due to potential systemic absorption of silver 
Exufiber 
• 
Maceration 
• 
Prolonged wound healing 
• 
Dressing related pain and/or trauma to the wound bed and edges 
• 
Infection 
Aquacel Ag Extra is assumed to have the same identified risk as Exufiber Ag+, since Exufiber Ag 
+  is substantially equivalent with Aquacel Ag Extra.  
The investigator should take the above mentioned list of events in consideration when reporting 
and assessing events in accordance with section 9 of the CIP. 
Based on the risk management record it can be concluded, that for Exufiber Ag+, Exufiber and 
Aquacel Ag Extra, there are no unacceptable risks of harm for the patient, the user nor third part 
involved in this clinical investigation, if the treatment dressings are used under normal conditions 
and within its intended use. 
Before reaching the above conclusion, the identified risks of the investigational device, which had 
been ranked for severity, occurrence and detectability according to Mölnlycke risk management 
process, were mitigated as far as possible in the risk management process (following ISO 14971, 
Application of Risk Management to Medical Devices). 
4.6 Data Quality Assurance 
4.6.1 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 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 39(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
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 
eCRF. Source data verification (a comparison of data in the eCRF with the subject’s 
hospital/practice and other records at the investigation site) with direct access to records will also 
be performed. 
A Monitoring Plan will be developed to be followed by the monitor. 
The monitor, delegate or other Mölnlycke personnel will be available between visits if the 
investigator or other staff at the site needs information and/or advice. 
Authorized representatives of Mölnlycke 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. 
4.6.2 Training of Staff 
The Principal Investigator will ensure that appropriate training relevant to the investigation is 
given to investigators and investigation site staff as well as community nurses and that new 
information of relevance to the performance of this investigation is forwarded to the staff involved. 
The Principal Investigator will also ensure that the involved site staff are experienced in wound 
care.  
Before the first subject is entered into the investigation, Mölnlycke personnel or delegate will 
conduct a site initiation visit. The purpose of the visit is to provide training to the involved 
personnel including, but not limited to the following items: 
• 
Clinical investigation plan (CIP) and execution thereof  
• 
Good Clinical Practice (GCP)  
• 
Use of eCRF system (Viedoc) 
• 
Use of investigational devices, and additional dressings used in the investigation. A training 
record will be provided to all trained staff. 
• 
Tissue and Exudate sampling (only applicable for site no 01 for subjects recruited before 
September 2018) 
• 
Safety Handling 
• 
Maintenance of the Investigator Study File 
4.6.3 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 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 40(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
• 
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) 
• 
Clean-file process including execution of post-entry checks and listings 
• 
Post clean-file tasks 
Viedoc, a web based eCRF system, will be used to capture data in this investigation. The eCRF 
system complies with FDA Title 21 CFR 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 Mölnlycke 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 code. Uploaded photos shall 
not contain any information that can reveal the identity of the subject. All uploaded photos will be 
reviewed by personnel at Mölnlycke and stored in the company database. All data entered in 
Viedoc will be encrypted. The physical database will be stored in Sweden. 
Records will be retained for a minimum of 10 years after end of the clinical investigation or last 
product is manufactured whichever is more stringent. In addition investigation sites shall keep 
their records longer if in accordance with local requirements. 
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 Mölnlycke so that there are no 
unexplainable empty fields in Viedoc. This is done in order to prevent that data have been 
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. 
4.7 Statistical Methods and Determination of Sample Size 
4.7.1 Statistical Evaluation 
General Methodology  
The main focus and analysis will be the analysis of the subjects treated with Exufiber Ag+.  
The main analyses will be change in primary and secondary efficacy endpoints from baseline to 4 
weeks on the ITT population in this group treated with Exufiber Ag+. If missing values at 4 weeks 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 41(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
last observation carry forward (LOCF) will be applied from 1 week. 
A sensitivity analysis will be performed for primary analysis with complete cases. 
Complementary analyses will be performed on the PP population and for change from baseline to 
3 days, 1 week, 2 weeks and 3 weeks.  
Since primary efficacy variable and most of the secondary efficacy variables are ordered 
categorical or dichotomous variables the Sign test will be used for analysis of change within 
groups for these types of variables and described with number and percentages of improved, not 
changed and worsened. For primary efficacy variable and important secondary efficacy variables 
a complete cross tabulation baseline and 4 weeks will be given. 
All significance test will be two-sided and conducted at the 5 % significance level. 
Continuous variables will be described with mean, SD, median, minimum and maximum and 
categorical variables will be given with number and percentages. All measured variables will be 
describes by visit. 
The statistical analysis of the groups treated with Exufiber or Aquacel Ag Extra will be analysed 
separately with the same statistical methods as specified above. The database for Exufiber Ag+ 
will be declare clean and will be analysed before the other two treatment groups are finalised. 
 
Patient Disposition and Data Sets Analysed 
The number of subjects included in each of the ITT, PP and safety populations will be 
summarized. The number and percentage of subjects enrolled and treated will be presented. 
Subjects who completed the study and subjects who withdrew from study prematurely will also be 
presented with a breakdown of the reasons for withdrawal for the ITT, PP and safety populations. 
 
Protocol Violations/Deviations 
Major protocol deviations are those that are considered to have an effect on the primary analysis. 
A list of potential major protocol deviations will be generated programmatically from the data 
captured before the clean file meeting. The listings from the clinical investigation will be reviewed 
and the finalisation of the major protocol deviations will be done at the clean file meeting.  
The number of patients with major protocol deviations will be summarized.  
Demographics and Baseline Characteristics 
All variables measured at baseline will be summarized for the ITT- and PP population using 
appropriate summary statistics for the three treatment groups. 
Medical and Surgical History 
Listings of all medications collected for each subject by the investigator will be produced. 
Prior and Concomitant Medications 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 42(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
Listings of all medications collected for each subject by the investigator will be produced. 
4.7.2 Performance Analysis 
Primary Performance Analyses 
The primary performance analysis will be the analysis of change in Exudate level from baseline to 
4 weeks in the Exufiber Ag+ treatment group with the two-sided Sign test on the Intent To Treat 
(ITT)-population at significance level 0.05. If the 4 weeks value is missing last observation carry 
forward (LOCF) will be allied from 1 week. 
A complementary sensitive analysis will be performed with the same analysis on complete cases. 
(No imputation) 
Secondary Efficacy Analyses 
All secondary efficacy variables will be analysed within the treatment groups for the ITT- and Per 
Protocol (PP) population using the statistical methods given in section general methodology. 
Primary efficacy variable will also be analysed on the PP-population 
4.7.3 Determination of Sample Size 
In the study PUMA 416, with 100 subjects treated with Mepilex without Ag, the result regarding 
change in Exudate level from baseline to 4 weeks was 56.5 % improved, 32.9 % unchanged and 
10.6 % worsened. Assuming the same proportions in this study 38 subjects are needed to find a 
significant improvement with the Sign test with 95% power and significance level 0.05. If we 
expect a dropout rate of around 20% we will include 50 subjects in the Exufiber Ag+ treatment 
group. 
4.8 Changes to the Clinical Investigation Plan 
No change in the investigation procedure will be effected without the mutual agreement of the 
Principal Investigator and Mölnlycke. 
An amendment to the Investigation Plan may require notification or approval from IRB before 
implementation. Local requirements must be followed. 
Mölnlycke will distribute clinical investigation plan amendments to the Principal Investigator who 
is responsible for the distribution of these documents to the IRB and staff concerned at his/her 
site. 
5. STATEMENTS OF COMPLIANCE 
5.1 IRB 
5.1.1 IRB review  
The final clinical investigation plan, including the final versions of the Patient Information and 
Consent Form, must be approved or given a favourable opinion in writing by an IRB before 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 43(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
enrolment 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 clinical investigation will be performed in accordance with the ethical principles that have 
their origin in the most recent version of the Declaration of Helsinki, ISO 14155:2011 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 (including photo consent) about the nature, purpose, possible risks and benefits of 
the investigation.  
For subjects unable to consent, permission will be obtained from their legally authorized 
representative (LAR). In this case, the priority order to obtain authorization will be as follows: 
spouse, adult child, durable power of attorney for health care, court appointed guardian for 
healthcare decisions. Assent from patients will not be collected nor documented as subjects 
unable to consent will be unresponsive and/or unconscious.  
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. The subject’s signed informed consent has to be obtained before conducting any 
procedure specifically for the investigation. 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. 
The Principal Investigator will also ensure that subjects are informed if any new relevant 
information becomes available during the investigation. 
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 Mölnlycke. 
 
 
5.2 Regulatory and standards 
5.2.1 Regulatory review 
Not applicable. The investigational device are 510(k) cleared.  

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 44(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
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. The abbreviated requirements as described in 21 CFR 812.2(b). 
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 Mölnlycke and/or EC/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 Mölnlycke will be identified by subject number 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 has product liability insurance, which also covers test products. 
6. INVESTIGATION TIMETABLE AND TERMINATION 
Estimated date of first subject enrolled Q2 2017  
Estimated date of last subject completed Q1 2019   
Estimated date of end of clinical investigation (database lock) Q1 2019  
The investigation could be prematurely discontinued if the investigation site is unable to fulfil the 
inclusion period according to the Clinical Investigation Agreement. 
7. PUBLICATION 
7.1 Publication policy 
Exufiber Ag+ 01 will be registered in a public database, ClinicalTrails.gov.  
 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 45(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
8. LITERATURE REVIEW AND REFERENCES 
In order to determine the scientific background for this clinical investigation as well as to assess 
risks/benefits of the device, a literature review was conducted. The literature listed below was 
critically evaluated before serving as background information. 
1. EWMA document, Antimicrobials and Non-healing wounds, Evidence, controversies and 
suggestions. Journal of Wound Care, 2013; 22 :1-92 
 
2. Tegel G, Schiffer D, Sigl E, Heinzel A, Guebitz G. Biomakers for infection: enzymes, 
microbes, and metabolites. Appl Micorbiol Biotechnol, 2015; 99: 4595-4614. 
 
3. Lindley L, Stojadinovic O, Pastar I, Tomic-Canic M. Plast. Biology and Biomarkers for Wound 
Healing. Reconstr. Surg, 2016; 138: 18S. 
 
4. Hodkinson B, Grice E. Next-Generation Sequencing: A Review of Technologies and Tools for 
Wound Microbiome Research Advances in Wound Care, 2015; 4: 50-58 
 
5. Rhoads D, Wolcott R, Sun Y, Dowd S. Comparison of Culture and Molecular Identification of 
Bacteria in Chronic Wounds, Int. J. Mol Sci. 2012; 13: 2535-2550. 
 
6. Leaper D, Münter C, Meaume S, Scalise A, Blanes Mompó N, Petersen Jakobsen B, Gottrup 
F. The Use of Biatain Ag in Hard-to-Heal Venous Leg Ulcers: Meta-Analysis of Randomised 
Controlled Trails. Plos One.,2013; 8:1-7. 
 
7. Kotz P, Fisher J, McClunskey P, Hartwell S, Dhrama H. Use of a new silver barrier dressing, 
Allevyn Ag in exuding chronic wounds. International Wound Journal, 2009; 6:186-194 
 
8. International Consensus, Appropriate use of sliver dressing in wounds. Wounds International, 
2012: 1-20 
 
9. Cangelosi G, Meschke J. Dead or Alive: Molecular Assessment of Microbial Viability. Appl. & 
Enviro. Microbiol., 2014;80: 5884-5891. 
 
10. Gil et al. Gil J, Valdes J, Solis M, Higa A, Parajon F, Li J, and Davis SC. Evaluation of a 
gelling fibre dressing with silver to eliminate Methicillin Resistant Staphylococcus aureus 
(MRSA) biofilm infection and enhance the healing in partial thickness porcine wound model. 
Poster presented at 30th SAWC meeting in San Diego 2017. 
 
11. Valdes et al.  Valdes J, Gil J, Higa A, Solis M, Parajon F, Li J and Davis SC . Evaluation of a 
gelling fibre dressing with silver to eliminate Pseudomonas aeruginosa biofilm infection and 
enhance the healing in partial thickness porcine wound model. Poster presented at 30th 
SAWC meeting in San Diego 2017. 
 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 46(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
12. Romanelli M, Vowden K, Weir D. Exudate Management. Wounds International, 2009; 1-6 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 47(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
9. DEFINITIONS AND PROCEDURES FOR REPORTING OF 
ADVERSE EVENT, ADVERSE DEVICE EFFECT, SERIOUS 
ADVERSE EVENT, SERIOUS ADVERSE DEVICE EFFECT 
AND DEVICE DEFICIENCY  
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 treatment dressings. 
Note:  
• 
This definition includes events related to the treatment dressings. 
• 
This definition includes events related to the procedures involved. 
• 
For users or other persons, this definition is restricted to events related to treatment 
dressings. 
Adverse Device Effect (ADE)  
Adverse Event related to the use of the treatment dressings  
Note:  
• 
This definition includes adverse events resulting from insufficient or inadequate instructions 
for use, deployment, implantation, or operation, or any malfunction of the treatment dressings. 
• 
This definition includes any event resulting from use error or from intentional misuse of the 
treatment dressings. 
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-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 48(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
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. 
Pregnancy 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, within 1 calendar 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 occur during the Clinical Investigation shall be reported, whether or not they 
are considered causally related to the investigational device [or the comparator]. 
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 Mölnlycke 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-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.com  

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 49(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
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  
Procedures for ADE reporting 
All ADE shall be reported by the investigator to Mölnlycke as soon as possible without unjustified 
delay. When an ADE 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 
This includes also ADEs occurring in all treatment groups. 
 
 
Causality Assessment 
The relationship between the use of the investigational devices and the occurrence of each 
AE/SAE shall be assessed by the investigator and the sponsor and classified as device related or 
not related to the device. 
PROCEDURES FOR SAE AND/OR SADE REPORTING OR REPORTING OF DD THAT 
COULD HAVE LED TO A SAE 
Report by the investigator to Mölnlycke 
The investigator must inform Mölnlycke, within 1 calendar day after investigation site personnel’s 
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 occur during the Clinical Investigation and new findings/updates in relation 
to already reported events must be reported, whether or not they are considered causally related 
to the investigational device [comparator] or procedure. 
Device Deficiencies that might have led to SAE 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 SAE. 
The investigator is responsible for informing the EC/IRB and/or the Competent Authority of the 
SAE/SADE as per local requirements. 
An assessment including causality to the investigational device or procedure and the seriousness 
of the ADE will be done by the investigator and Mölnlycke Any event reported by the investigator 

 
Clinical Investigation Plan 
Document ID:  PD-523857 Rev: 01 
 
 
Title: CIP with integrated central Amendments 1 and 2 ExufiberAg+01 
Page 50(50) 
Investigation Code ExufiberAg+01Final Version 
Approval date 
2017-05-10 
                                                                    Amendment 1 Approval date 
2017-05-26 
                                                                    Amendment 2 Approval  date  2018-08-07 
                                                                    Amendment 3 Approval date   2018-08-21 
                                                                    Amendment 4 Approval date  2019-02-19 
                                                                                     
 
 
                                   
Document template: F-167 Clinical Investigation Plan 
Rev: 10 
 
 
as serious but assessed as non-serious by Mölnlycke will be reported to the Competent 
Authorities as described below for SAE reporting to CA. Both Investigators and Mölnlycke opinion 
will be communicated. 
PROCEDURES FOR DD REPORTING  
All DD shall be reported by the investigator to Mölnlycke 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 
device was used by a subject or not. Separate forms are used for subject related and non-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.com 
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 
An assessment will be done by the investigator and Mölnlycke including a determination if the DD 
could have led to a SAE if either a) suitable action had not been taken, b) if intervention had not 
been made, or c) if circumstances had been less fortunate will be done. If the result by the 
assessment by the investigator or Mölnlycke is that the DD could have led to a SAE it must be 
reported as described above for SAE reporting to CA. In case of differences in the assessment by 
the investigator or Mölnlycke both opinions will be communicated. 
Procedures for ADE reporting 
All ADE shall be reported by the investigator to Mölnlycke as soon as possible without unjustified 
delay. When an ADE 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 
This includes also AEs occurring in the comparator arm if applicable. 
An assessment including causality to the investigational devices or procedure and the 
seriousness of the ADE will be done by the investigator and Mölnlycke.