Incision Management With Prevena After Renal Transplant (IMPART) Trial: Negative Pressure Wound Therapy Versus Standard Dressings for Incision Management After Renal Transplant: a Multicentre, Partially-blinded Randomised Controlled Trial
Phase: NA
Conditions: Wound Complication
Sponsor: Royal North Shore Hospital

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
Page 1 of 27 
 
 
 
Negative pressure wound therapy (PREVENA) versus standard dressings for 
incision management after renal transplant: a multicentre, partially-blinded 
randomised controlled trial 
 
Incision Management with Prevena After Renal Transplant (IMPART-TRIAL) 
 
 
 
 
CONFIDENTIAL 
This document is confidential and the property of Department of Vascular Surgery, RNSH 
No part of it may be transmitted, reproduced, published, or used without prior written authorisation 
from the author, Dr Christopher Selvaraj at selvaraj.chris@gmail.com. 
 
STATEMENT OF COMPLIANCE 
 
This document is a protocol for a clinical research study. The study will be conducted in compliance 
with all stipulations of this protocol, the conditions of ethics committee approval, the NHMRC National 
Statement on Ethical Conduct in Human Research (2007) and the Note for Guidance on Good Clinical 
Practice (CPMP/ICH-135/95). 
 
 
 
 
 
 
 
 
 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
Page 2 of 27 
Contents 
STATEMENT OF COMPLIANCE ................................................................................................................ 1 
PROTOCOL SIGNATURE PAGE ................................................................................................................. 3 
INVESTIGATORS SIGNATURE PAGE......................................................................................................... 4 
PROTOCOL SYNOPSIS……………………………………………………………………………………………………………………….…5 
GLOSSARY OF ABBREVIATIONS .............................................................................................................. 6 
STUDY MANAGEMENT ........................................................................................................................... 7 
Introduction and Background ................................................................................................................. 7 
Research Question ................................................................................................................................. 8 
Rationale for Current Study .................................................................................................................... 8 
Study Objectives ..................................................................................................................................... 8 
Study Design ........................................................................................................................................... 9 
Participant Enrollment and Randomisation ......................................................................................... 11 
Informed Consent Process ................................................................................................................... 12 
Study Visits and Procedures Schedule ................................................................................................. 14 
Study Flow Chart .................................................................................................................................. 14 
Clinical and Laboratory Assessments ................................................................................................... 15 
Adverse Event Reporting ...................................................................................................................... 15 
Definitions ............................................................................................................................................ 15 
Eliciting Adverse Event Information ..................................................................................................... 16 
Serious Adverse Event Reporting ......................................................................................................... 16 
SUSARs .................................................................................................................................................. 16 
Statistical Methods ............................................................................................................................... 16 
Sample Size Estimation ......................................................................................................................... 16 
Population to be analysed .................................................................................................................... 16 
Statistical Analysis Plan ........................................................................................................................ 18 
Interim Analyses ................................................................................................................................... 18 
Data Management ................................................................................................................................ 18 
Administrative Aspects ......................................................................................................................... 19 
Use of Data and Publications Policy ..................................................................................................... 20 
REFERENCES ......................................................................................................................................... 20 
APPENDICES .......................................................................................................................................... 22 
 
 
 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
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Protocol Signature Page 
 
 
Protocol prepared by:  
 
Dr Christopher Selvaraj 
Vascular Surgery Registrar 
Clinical Trials Office 
Administration Area 3E South 
Royal North Shore Hospital 
St Leonards 
NSW 2065 
selvaraj.chris@gmail.com 
 
 
 
 
 
 
_____________________________________ 
Signature and date 
 
Linda Pallot RN 
Vascular Surgery Research Nurse 
Clinical Trials Office 
Administration Area 3E South 
Royal North Shore Hospital 
St Leonards 
NSW 2065 
Linda.Pallot@health.nsw.gov.au 
 
 
 
 
 
 
 
______________________________________ 
Signature and date 
 
Approved by: 
 
Dr Vikram Puttaswamy 
Head of Department Vascular Surgery  
Clinical Trials Office 
Administration Area 3E South 
Royal North Shore Hospital 
St Leonards 
NSW 2065 
shevvik@optusnet.com.au 
 
 
 
 
 
______________________________________ 
Signature and date 
 
 
 
 
 
 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
Page 4 of 27 
 
 
Protocol Signature page – All Investigators 
 
 
I have read this protocol and agree to adhere to, the protocol, the local IRB/IEC regulatory 
requirements and the ICH Harmonised Guideline Integrated Addendum To ICH E6(R1): Guideline For 
Good Clinical Practice: E6(R2) 
I will provide copies of this study protocol and all necessary information about this study to the study 
staff under my supervision. 
I will discuss this material with them and ensure they are fully informed about the device under 
investigation as well as the aspect concerning the conduct of the study. 
 
Investigator 
 
 
Name: _____________________________________________________________________ 
Institution: _________________________________________________________________ 
Address: ___________________________________________________________________ 
Phone: ________________________________________________ 
Email: ________________________________________________ 
Signature: _____________________________________________                                                                
Date: _________________________________________________ 
 
 
 
 
 
 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
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PROTOCOL SYNOPSIS 
Title 
Incision Management with Prevena After Renal Transplant (IMPART-
TRIAL) 
Objectives 
 
Primary: The primary objective of this study is to determine if the Prevena 
Incision Management System reduces wound complications at the surgical 
site following renal transplant, when compared to standard dressings. 
Secondary: Secondary objectives of this study include identification of risk 
factors for wound complications at the surgical site, as well as 
reoperation, prolonged hospital stay, allograft survival, delayed graft 
function. This study will also assess pain, scar healing and quality of life in 
each treatment arm, and aim to complete a cost-benefit analysis of the 
Prevena device in renal transplantation. 
Study Design 
This study is a multicentre, partially-blinded randomised controlled trial, 
with site stratified block randomisation and partial blinding of outcome 
assessments. Patients undergoing a renal transplant will be allocated to 
one of two treatment arms, where either a Prevena device of appropriate 
size or standard dressing is applied to the closed incision. In the case that 
a patient requires bilateral incisions, both incisions will be allocated to the 
same treatment arm and counted as a single incision. 
Planned Sample Size 
250 participants each arm (500 total) 
Selection Criteria 
All patients presenting for a renal transplant over a 24 month period at 
one of the participating sites will be eligible for enrolment in this study. 
Only participants who give informed consent will be enrolled in the study.  
Study Procedures 
Participants will be randomised to either a Prevena (intervention arm) or 
standard dressing (control arm) is placed on the closed incision after renal 
transplantation. Monitoring will occur daily during hospitalization and up 
to 30 days postoperatively to review any wound complications, with 
subsequent assessment at 90 days. 
Statistical Procedures 
and 
Analysis Plan: 
Statistical analysis will be pre-specified and conducted according to both 
principles of intention of treat and per-protocol analysis, using SPSS 
version 20 (IBM, Armonk, NY, USA The Intention to Treat (ITT) sample will 
be based on all enrolled subjects, and the per-protocol analysis will be 
based on all patients who have a dressing placed on the closed incision 
following renal transplant. Each incision will be randomized to the 
Prevena or standard dressing group. In the case that a patient requires 
bilateral incisions, both incisions will be allocated to the same treatment 
arm and counted as a single incision. Baseline characteristics of the two 
groups will be recorded and compared using Student’s t-test and chi-
square test for continuous and discrete data respectively. The primary 
outcome, the proportion of wound complications, will be compared 
between the Prevena and standard dressing groups using a chi-square 
test without Yates’ continuity correction with a two-sided alpha of 0.05 at 
the final analysis using the Peto approach to preserve the overall 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
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GLOSSARY OF ABBREVIATIONS 
 
ABBREVIATION 
TERM 
CNC 
Clinical Nurse Consultant 
NPWT 
Negative Pressure Wound Therapy 
Prevena 
PREVENA Incision Management System 
SD 
Standard (waterproof, adhesive) Dressings  
RT 
Renal Transplant 
RNSH 
Royal North Shore Hospital; Sydney, Australia 
RPAH 
Royal Prince Alfred Hospital; Sydney, Australia 
WH 
Westmead Hospital; Sydney, Australia 
HD 
Haemodialysis 
PD 
Peritoneal dialysis 
LOS 
Length Of Stay 
EC 
Ethics Committee 
PISCF 
Patient Information Sheet and Consent Form 
ITT 
Intention to Treat 
IFU 
Instructions for Use 
EQ-5D-5L 
A Quality of life standardised instrument developed by the EuroQol Group 
NRS 
Numerical Rating Scale 
POSAS 
The Patient and Observer Scar Assessment Scale 
MCS 
Microscopy, Culture and Sensitivity 
REDCap 
Research Electronic Data Capture 
1. 
STUDY MANAGEMENT  
1.1 
Principal Investigator 
significance level of 0.05 (23).  Patients lost to follow-up will be used in an 
intention-to-treat analysis with last observation carried forward  
The secondary outcome of identification of risk factors for wound 
complications will be assessed by multiple logistic regression of collected 
variables to assess their odds ratio.  
Sample Size Calculation: 
 
Wound infection rates have been estimated between 5 and 30% based on 
current literature, including a systematic review and meta-analysis.(3)(10) 
Weighting the participating site’s preliminary audit data by expected 
enrolment rates, the average wound complication rate was estimated to 
be 15%. NPWT has been suggested to offer an approximate 46% 
reduction in wound infection rates for abdominal incisions (3)(10). Based 
on a type one two-sided error of α = 0.05 and a type two error of β = 0.2 
(corresponding to a power of 80%) a total sample size of 239 patients per 
group (478 in total) is needed to evaluate primary endpoints, which was 
calculated using the power formula for a chi-square test without Yates’ 
continuity correction due to the large sample size and binary dependent 
variable (17). Accounting for potential loss to follow up, the sample size 
has been rounded up to 250 per arm (500 total). 
Duration of the study 
24 months 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
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Dr Christopher Selvaraj, RNSH 
1.2 
Chief Investigator  
Dr Vikram Puttaswamy, RNSH 
1.3 
Associate Investigators 
Dr Cindy Wang; RNSH 
Dr Jerome Laurence; RPAH 
Dr Henry Pleass; Westmead Hospital 
 
1.4 
Statistician 
Statisticians will be based in the Surgical Education, Research and Training (SERT) Institute at Royal 
North Shore Hospital. 
  
1.5 
Sponsor 
Northern Sydney Local Health District 
1.6 
Funding and resources 
Internal funding from each centre. 
2. 
INTRODUCTION AND BACKGROUND 
2.1   
Background Information 
Renal transplantation is considered to be the best treatment option for patients with end stage kidney 
disease in terms of quality of life and survival outcomes, as well as relative cost efficiency compared to 
dialysis.(1) Transplant recipients are susceptible to wound complications, arguably the most common 
post-transplant surgical complication, which may contribute to an additional risk of graft rejection or 
failure, prolonged length of stay, readmission and re-operation, as well as increased treatment costs. 
(2)  
 
Wound complications have been previously superficial or deep dehiscence and/or infection, perigraft 
collections or seromas, cellulitis, lymphocoeles, and prolonged wound drainage. Studies have shown 
that the most important risk factors for wound complications in transplantation are 
immunosuppression and obesity (3). The incidence of wound infection in the presence of 
immunosuppression is approximately 7%, and more potent immunosuppressive agents are thought to 
result in a higher incidence of wound complications. (4) Comparing patients with high (>30) and low 
BMI (<30) patients, meta-analyses have demonstrated a significantly higher risk of wound infection (RR 
= 3.13, CI, 2.08–4.71; P <0.001), and wound dehiscence (RR 4.85, CI, 3.25–7.25; P <0.001). (5)(6)  
 
Other relevant factors in renal transplantation include surgical technique and expertise, reoperative 
procedures, the presence of a haematoma, as well as recipient comorbidities such as advanced age, 
diabetes, malnutrition, dialysis (haemo- and peritoneal), and prolonged uraemia. The surgical closure 
technique of the incision, in particular, the precise closure of defects in each layer, has also been 
identified as an independent factor in reducing wound complications. (7) (8) 
 

 
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Protocol V2, dated 21 December 2018 
 
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Negative pressure wound therapy (NPWT) utilises a foam sponge, in combination with a 
semipermeable adhesive dressing and a vacuum pump device to increase blood flow, drain fluid and 
exudate, and contract wound edges. Meta- analyses have suggested that when compared to standard 
wound dressings on closed incisions, NPWT significantly decreases wound size and healing time, with a 
significant reduction of risk of surgical site infections (RR=0.54, p= 0.01), and a significant reduction in 
risk of seroma formation (RR=0.48, p=0.01).  (9) (10) (11).   
 
In high risk wounds following cardiac and orthopaedic surgery, NPWT has been used safely without 
complications. (12) (13) Furthermore, international studies have demonstrated through cost-utility 
analysis that closed-incision negative-pressure therapy is likely a cost-saving technology when used in 
high-risk patients following abdominal incisions. (14) 
 
2.2  
Research Question   
In patients undergoing a renal transplant (RT), does the application of negative pressure wound therapy 
(NPWT) with a Prevena Incision Management System (Prevena) immediately to the closed wound at the 
end of the renal transplant operative procedure result in fewer wound complications, when compared 
to standard adhesive, waterproof dressings (SD)? 
2.3         Rationale for Current Study 
The Prevena Incision Management System (Prevena; Kinetic Concept Inc. San Antonio, Texas, United 
States) is a portable NPWT device, utilising a foam interface containing 0.019% ionic silver. Since the 
first published case of its use in renal transplantation in 2015, a systematic review the following year 
concluded that the Prevena had been successfully used following renal transplantation to heal infected 
and dehisced wounds, as well as lymphocoeles and urine leaks. (15)(16)  
Due to the multifactorial nature of wound complications following renal transplantation, controversy 
still exists regarding the utility of preventative management of wound complications, and current 
literature has identified a further need for robust evidence regarding the safety and efficacy of NPWT in 
renal transplantation, ideally in the form of a randomised controlled trial. (3)(10) (16)  
This study is a multicentre, partially-blinded, randomised controlled trial of the Prevena Incision 
management system versus standard adhesive, waterproof dressings on closed-incisional wounds 
following renal transplantation, to evaluate outcomes on wound healing in the postoperative period. 
3 
     STUDY OBJECTIVES  
3.1 
Primary Objective 
 
The primary objective of this study is to determine if the Prevena Incision Management System reduces 
all possible wound complications at the surgical site following renal transplant, when compared to 
standard dressings. 
 
 
 
 
3.2 
Secondary Objectives 

 
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Protocol V2, dated 21 December 2018 
 
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Secondary objectives of this study include identification of risk factors for wound complications at the 
surgical site, as well as reoperation, prolonged hospital stay, allograft survival, delayed graft function. 
This study will also assess pain, scar healing and quality of life in each treatment arm, and aim to 
complete a cost-benefit analysis of the Prevena device in renal transplantation.  
4.   
STUDY DESIGN  
4.1     Type of Study 
This study is a multicentre, partially-blinded, randomised controlled trial, with site stratified block 
randomisation and partial blinding of outcome assessments. Patients undergoing a renal transplant will 
be allocated to one of two treatment arms, where either a Prevena or standard dressing is applied to 
the closed incision. 
 
4.2     Study Design  
Ethics approval will be obtained from SLHD-RPA by the Lead site at RNSH. All sites will require 
Governance approval prior to study commencement. Enrolled participants in this study will present for 
renal transplantation at a participating study site, having received routine planning and workup for the 
operation which will include education regarding the trial, and providing informed consent at the time 
of admission for the operation. Study investigators will register the patient in an online database 
(REDCap Database Vanderbilt University) controlled by the study investigators, which will randomly 
allocate the patient to a treatment arm, to be revealed after transplantation and during the closure 
procedure (closure defined as closure to the muscle, subcutaneous tissue or skin). Patient data 
variables including demographic data, medical comorbidities and pathology results will be recorded 
from the patient electronic medical record (see appendix). Details of the donor kidney will be also be 
recorded, including donor demographics, anatomical characteristics, ischaemic time, and time of 
retrieval.  
 
The patient will be prepared for surgery as per site specific protocols; variables to be recorded include 
peri operative antibiotic administration and skin preparation (application of an antiseptic agent such as 
chlorhexidine or iodine, or iodine impregnated drapes). Each surgeon will proceed with the procedure 
of renal transplantation as per operator preference. Operative details to be recorded include site and 
side of incision (Rutherford-Morrisson), warm ischaemic time, time of reperfusion, operation duration, 
estimated blood loss, length of incision, and method (materials; eg. sutures, staples) of closure in layers 
(muscle, subcutaneous tissue and skin). Drain presence and placement is also recorded. Bilateral renal 
transplants and bilateral incisions will be counted as one incision and will allocated to the same 
treatment arm as one entity. 
 
The intervention arm will have the closed incision dressed with the Prevena Incision Management 
System (Kinetic Concepts Inc, San Antonio, TX, USA), a portable NPWT device, utilising a foam interface 
containing 0.019% ionic silver. The Prevena is preset to a continuous vacuum suction at 125mmHg. The 
Prevena  device of appropriate size is to be applied under sterile conditions at the time of closure of the 
incision, with drain placement to be >10cm from the wound edge. The device should remain intact for a 
total of 7 days, at which point it will be removed. The wound will be inspected by a study investigator 
for evidence of a wound complication. A dressing may be reapplied, including a Prevena dressing if 
thought clinically indicated by the presence of a wound complication.  
 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
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Postoperative ultrasound of the grafted kidney may be performed by peeling back the adhesive 
component of the Prevena dressing, and the Prevena can be subsequently reinforced with an adhesive 
dressing to establish adequate seal, with suction reinitiated within one hour if lost. If the wound edge is 
exposed, the Prevena device is inadvertently removed during ultrasound or clinician concern regarding 
the wound or device results in removal of the Prevena device earlier than planned, the device can be 
replaced at investigator discretion, however these details must be documented in the database. The 
patient will continue in the intervention arm as per principles of intention to treat regardless of 
whether the Prevena is replaced.  
 
The control arm will have the closed incision dressed with a standard waterproof, adhesive dressing at 
the operator’s discretion. This will not be controlled, but the type of dressing used will be recorded. 
This dressing will remain intact for a minimum of 7 days and may be changed thereafter as per site 
specific practices, which will be documented. 
 
The perioperative recipient management will otherwise be identical in both the intervention and the 
control arms and guided by site specific protocols. Data will be recorded daily until the date of 
discharge regarding site specific practices in regard to immunosuppression, antibiotics, imaging, drain 
management, and pathology results. If the patient is discharged with a drain, volumes must be 
recorded till the date of removal. If the patient re-presents to hospital with a wound complication, 
requires a re-operation or subsequent interventions, this is recorded for the requisite primary and 
secondary endpoints by the study investigators.  
 
All patients will follow up at time points below, for assessments of the surgical site and overall health 
(see appendix). The date of drain removal and volumes drained will be confirmed and recorded if the 
patient was discharged with a drain. On review, patients may also undergo an ultrasound, or other 
suitable imaging at investigator discretion, to determine the presence of deep wound complications. 
Imaging staff to will be blinded to the patients allocated treatment arm in the trial. 
 
The timeline for patient follow up and assessment is as follows:  
 
Day 7 – The dressing is taken down for review and not replaced unless indicated. The review will 
include a microbiology swab (MCS), photo of the wound, modified ASEPSIS wound assessment, a pain 
assessment (NRS) and patient quality of life questionnaire (EQ-5D). 
 
Day 14 – The dressing is taken down for review and not replaced unless indicated. The review will 
include a microbiology swab (MCS), photo of the wound, modified ASEPSIS wound assessment, a pain 
assessment (NRS), and quality of life questionnaire (EQ-5D). 
 
Day 30 (+/- 3 days) – The patient will present for follow up for an extended wound review by a study 
clinician or wound CNC, and a vascular sonographer. The review will include a modified ASEPSIS wound 
assessment, a photo of the wound, a pain and scar assessment (POSAS), a quality of life questionnaire 
(EQ-5D), and an ultrasound of the transplanted kidney which will also identify deep wound 
complications.  
 
90 days (+/- 3 days) – The patient will present for follow up for wound review and ultrasound, which 
will include a photo of the wound, a scar assessment (POSAS), a quality of life questionnaire (EQ-5D), 
and an ultrasound of the transplanted kidney which will also identify deep wound complications. 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
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4.3   
Number of Participants 
Expected number of participants is 500, with approximately 250 patients allocated to each arm. 
 
4.4    
Study sites 
The study sites are Royal North Shore Hospital, Royal Prince Alfred Hospital and Westmead Hospital, 
located in Sydney, Australia. Outside the confines of this research protocol, surgeons at each site will 
perform the renal transplantation as per their own procedural methodology, and perioperative 
management will be as per site specific protocol and guidelines.  
 
4.5    
Expected Duration of Study 
The study is expected to commence in January 2019 and conclude in 2021. 
Expected duration of recruitment is 24 months and planned duration of follow up is 90 days. 
 
4.6    
Primary and Secondary Outcome Measures 
Primary outcomes of this study include wound infection, wound dehiscence or fluid collection at the 
surgical site within 30 postoperative days (see Appendix for Classification of wound complications) 
Secondary outcomes include pain, scar healing, quality of life, reoperation, duration and volume of 
wound drainage, graft function, hospital length of stay, clinical adverse events and mortality (see 
Appendix for NRS, POSAS, EQ 5D-5L and List of dependent variables).  
5.    
PARTICIPANT ENROLLMENT AND RANDOMISATION 
 
5.1    
Recruitment 
All patients presenting for a renal transplant over a 24 month at one of the participating sites will be 
eligible for enrolment in this study. Only participants who give informed consent will be enrolled in the 
study, and this will be done by a study investigator. Participants may be recruited at any point after 
written informed consent, prior to surgery. 
 
5.2    
Eligibility Criteria 
 
5.2.1 
Inclusion Criteria 
The participant: 
1. is an adult ≥ 18 years old, regardless of comorbidities or BMI 
2. is able to provide their own informed consent  
3. will undergo open renal transplant surgery, including those who undergo dual renal 
transplant or simultaneous pancreas transplant. 
4. will require a surgical incision(s) likely to be able to be covered completely by one or more 
Prevena Incision Management Systems. 
5. is willing and able to return for the required follow up assessments. 
6. if concurrently enrolled in a clinical trial it must not impact on patient health or the 
surgical incision site and the study must be documented 

 
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Protocol V2, dated 21 December 2018 
 
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5.2.2 
Pre-Operative Exclusion Criteria 
The participant: 
1. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic 
adhesives. 
2. Is not suitable for closure of the surgical wound, and as such the wound must be left 
open or an open NPWT device is required. 
3. Is not willing to comply with the study procedures.  
 
5.2.3 
Intra-Operative Exclusion Criteria  
The participant: 
1. Has an unforseen intraoperative event mandating additional management including a 
planned re-exploration.  
2. Has obvious intraoperative contamination of the surgical site. 
3. Has a wound with suspected ischaemia in the incision area, or inadequate haemostasis. 
4. Requires drains that cannot be covered by the Prevena dressing. 
5.3  
Informed Consent Process 
Informed consent should be obtained in accordance with the applicable regulations, and current 
versions of Declaration of Helsinki, ICH-GCP and ISO 14155. If a patient might be eligible for the study, a 
study investigator may approach them to obtain the written informed consent. During the consent 
process, the background of the proposed study including the benefits and risks of study participation 
should be explained in detail to the patient. 
 
It has to be emphasized that a patient’s participation in the trial is voluntary and that the patient may 
refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to 
which the patient is otherwise entitled. The patient must be given ample time to read the patient 
information and to address questions before signing the consent form. Study information and a copy of 
the Ethics Committee approved consent form will be signed (by the Investigator and participant). 
Patients are considered provisionally enrolled in the study once they have signed the Consent Form. 
Enrolled participants should be treated within 30 days from the day of Consent. If the index procedure 
is not performed within 30 days of the provisional enrolment the participant must be re-screened and 
written informed consent re-obtained.  
 
5.4   
Enrolment and Randomisation Procedures  
All patients presenting for a renal transplant over a 24 month period at one of the participating sites 
will be eligible for enrolment in this study. Patients who sign the Participant Information Sheet and 
Consent Form (PISCF) and fulfil all inclusion and exclusion criteria, as well as compliance with 
contraindications listed in the Prevena IFU, will be considered eligible for study participation. 
Participants may recruited at any point prior to surgery once surgery is confirmed, ideally at the time of 
admission to hospital for the procedure, or if this is not possible, at the time consent is obtained for the 
surgery. A unique study identification number is then assigned to enrolled participant by the study 
investigators. 
Participants who signed the PISCF but do not fulfil all inclusion and exclusion criteria, IFU 
related indications and contraindications, hospital standard of care tests, or who withdraw informed 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
Page 13 of 27 
consent prior to the procedure are screen failures. They will be documented on the screening and 
enrolment log with the screening failure reason.  For the purposes of analysis, an Intention to Treat 
(ITT) sample will be based on all enrolled subjects, and a secondary as per-protocol analysis will be 
based on all patients who have the intervention of having a dressing placed on the closed incision 
following renal transplant. 
 
Patient registration will occur prior to surgery on an online research database (REDCap; Vanderbilt 
University, Nashville, USA) hosted at Royal North Shore Hospital (19). Randomisation via REDCap will 
occur when the patient fulfils all intra-operative exclusion criteria and after commencement of skin 
closure (defined as closure to the muscle, subcutaneous tissue and skin). Randomisation will be 
stratified by site, with block randomisation by variable block size in a 1:1 ratio. , The surgical team, 
clinical staff, and patient will not be blinded to the intervention status. 
  
5.5    
Blinding Arrangements 
Study investigators will be partially blinded, as surgical proceduralists and treating clinical staff will be 
unable to be blinded due to the visually distinct difference between a Prevena and standard dressing. 
Study investigators will be able to identify the allocated treatment within 7 days due to active 
intervention and likely at 14 days due to ongoing clinical contact. However, wound assessment at Day 7 
and Day 14 (as well as Day 30 and 90) will include a photo of the wound by a study investigator once 
the dressing is removed, for independent blinded assessment by the designated wound assessor for 
each site (or alternative site for Day 30 and 90 photos); this is done to improve the validity of 
assessment. Blinding will occur at Day 30 and 90 follow up for imaging staff and the designated 
independent wound assessor for each site, who will not be informed of the allocated treatment arm. 
Patients will be instructed to not disclose this information to the wound assessor or imaging staff.  
 
5.6    
Participant Withdrawal 
 
5.6.1 
Reasons for withdrawal 
Patients may withdraw from the study at any point, but will continue to be followed up and managed as 
per routine practice. Patient withdrawal may also occur due to loss of follow up, adverse event or 
death. Investigators may withdraw the patient from the study once the patient has been randomised, if 
the Investigator believes the allocated treatment arm is not in the patient’s best interests, or the 
patient meets IFU related contraindications, however the reasons for withdrawal must be clearly 
documented.5.6.2 
Handling of withdrawals  
All participants withdrawn will ideally complete all study visits including Day 30 follow-up if able, as per 
routine clinical practice. Withdrawn patients will be included in an intention to treat analysis.  
5.6.3 
Study Closure  
Participants will be informed of study closure and will continue follow up as per 
routine clinical practice post transplantation. 

 
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Protocol V2, dated 21 December 2018 
 
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6 
STUDY VISITS AND PROCEDURES SCHEDULE 
Study Flow Chart 
 
Screening for inclusion and exclusion criteria 
 
Participant Information Sheet and Consent form (PISCF) signed by patient and study Investigator 
 
 
Enrolment  
 
Randomisation after transplantation and prior to skin closure 
 
Prevena Incision Management Device 
 
 
 Standard dressing 
 
 
 
  Applied for 7 days 
 
 
 
Applied for a minimum of 7 days 
 
 Wound assessed as per timeline below.  
 
    Wound assessed as per timeline below. 
 
Timeline for follow up wound assessments: 
 
Day 7 – The dressing is taken down for review and not replaced unless indicated. The review will 
include a microbiology swab (MCS); photo of the wound; modified ASEPSIS wound assessment; a pain 
assessment (NRS) and patient quality of life questionnaire (EQ-5D). 
 
Day 14 – The dressing is taken down for review and not replaced unless indicated. The review will 
include a microbiology swab (MCS); photo of the wound; modified ASEPSIS wound assessment; a pain 
assessment (NRS) and the quality of life questionnaire (EQ-5D). 
 
Day 30  (+/- 3 days) – The patient will present for follow up for an extended wound review by a study 
clinician or wound CNC, and a vascular sonographer. The review will include a modified ASEPSIS wound 
assessment; a photo of the wound; a pain and scar assessment (POSAS); a quality of life questionnaire 
(EQ-5D and an ultrasound of the transplanted kidney which will also identify deep wound 
complications. 
 
Day 90 (+/- 3 days)  – The patient will present for follow up for wound review and ultrasound, which will 
include a photo of the wound; a scar assessment (POSAS); a quality of life questionnaire (EQ-5D) and an 
ultrasound of the transplanted kidney which will also identify deep wound complications. 

 
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Event 
Day 0 
Enrolment 
Day  7 
Day 14 
Day 30 
 (+/- 3 days) 
Day 90 
(+/- 3 days) 
Screening for Inclusion / Exclusion criteria 
 
 
 
 
 
Participant Information Sheet and Consent Form 
(PISCF) 
 
 
 
 
 
Routine perioperative data collection  
(Appendix C) 
 
 
 
 
 
Modified ASEPSIS wound assessment 
(Appendix B) 
 
 
 
 
 
Photo of wound using REDCap App 
 
 
 
 
 
Quality of life questionnaire (EQ-5D-5L)  
(Appendix D) 
 
 
 
 
 
Microbiology swab (MCS) 
 
 
 
 
 
Pain Assessment (NRS) (Appendix G) 
 
 
 
 
 
Pain and Scar Assessment (POSAS) (Appendix E, F) 
 
 
 
 
 
Ultrasound of Transplanted Kidney (Study specific) 
 
 
 
 
 
Adverse Event & Serious Adverse Event Assessment 
 
 
 
 
 
7. 
CLINICAL AND LABORATORY ASSESSMENTS  
See Appendix C. 
8. 
ADVERSE EVENT REPORTING 
 
Adverse event reporting for clinical trials involving therapeutic products will meet the requirements of 
the National Health and Medical Research Council, Australian Health Ethics Committee (AHEC) Position 
Statement “Monitoring and reporting of safety for clinical trials involving therapeutic products” (May 
2009), which can be found at: 
www.nhmrc.gov.au/health_ethics/hrecs/reference/_files/090609_nhmrc_position_statement.pdf 
 
8.1 
  Definitions 
Adverse event 
An adverse event for medicines is also referred to as an adverse experience, any untoward medical 
occurrence in a patient or clinical investigation participant administered a pharmaceutical product and 
which does not necessarily have a causal relationship with this treatment. An adverse event can 
therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with 
the use of a medicinal (investigational) product, whether or not related to the medicinal 
(investigational) product. 
 
Devices Events 
An adverse event for devices is any undesirable clinical occurrence in a participant whether it is 
considered to be device related or not, that includes a clinical sign, symptom or condition and/or an 
observation of an unintended technical performance or performance outcome of the device. 
 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
Page 16 of 27 
In relation to devices any adverse medical occurrences include: death and or a serious deterioration in 
health of a patient user or other.  This would include: 
 
a life threatening illness or injury; 
 
a permanent impairment of body function or permanent damage to a body structure 
 
a condition requiring hospitalisation or increased length of existing hospitalisation 
 
a condition requiring unnecessary medical or surgical intervention or 
 
death or a serious deterioration in health had suitable action or intervention not taken place  
 
a malfunction of a device such that it has to be modified or temporarily/permanently taken out 
of service; or a factor (deterioration in characteristics or performance) found on examination of 
the device 
 
8.2 
  Assessment and Documentation of Adverse Events  
All adverse events (see Appendix C) will be documented in the study database.  
  8.3 
 Eliciting Adverse Event Information 
Adverse events (see Appendix C) will be reviewed and confirmed at the follow up assessments. 
8.3 
Serious Adverse Event Reporting 
8.3.1 
SAEs 
Serious adverse events will be recorded in the study data, and site-specific HREC reporting for incident 
and risk management will be followed. 
 
Serious adverse event (SAE): 
An unforeseen medical event that occurs in the course of clinical research that: 
 
results in participant death  
 
is life-threatening to the participant  
 
requires the inpatient hospitalisation or prolongation of existing hospitalisation and leads to the 
participant having a persistent or significant disability/incapacity. 
 
8.3.2 
SUSARs 
Suspected Unexpected Serious Adverse Reactions (SUSAR) will be recorded in the study data, and site-
specific HREC reporting for incident and risk management will be followed. 
9 
STATISTICAL METHODS 
9.1 
Sample Size Estimation 
Wound infection rate have been estimated between 5 and 30% based on a current literature, including 
a systematic review and meta-analysis.(3)(10) Weighting the participating site’s preliminary audit data 
by expected enrolment rates, the average wound complication rate was estimated to be 15%. NPWT 
has been suggested to offer an approximate 46% reduction in wound infection rates for abdominal 
incisions (3)(10).  
Based on a two-sided type one error of α = 0.05 and a type two error of β = 0.2 (corresponding to a 
power of 80%) a total sample size of 239 patients per group (478 in total) is needed to evaluate primary 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
Page 17 of 27 
endpoints, which was calculated using the power formula for a chi-square test without Yates’ continuity 
correction due to the large sample size and binary dependent variable (22). Accounting for potential 
loss to follow up, which is estimated to be minimal, as every patient receiving a kidney transplant is 
planned to follow up every day for 30 days postoperatively, the sample size has been rounded up to 
250 per arm (500 total). Missing data from patients who fail to have endpoints recorded will be treated 
on an intention to treat basis with last observation carried forward. 
Estimated mean wound complication rate in control arm across 3 sites : 15% 
Site 1 : 5-10% (60 transplants per year, audit data demonstrates 5% dehiscence rate) 
Site 2 : 8-15% (90 transplants per year, audit data demonstrates 8% infection rate) 
Site 3 : 18-25% (100 transplants per year, audit data demonstrates 18% dehiscence rate)  
Conservative estimate of treatment effect: ~50% reduction in all wound complications with closed 
incision NPWT over lower abdominal/groin wounds (Rutherford Morrison) in high risk population. 
Estimated complication rate for Prevena arm (intervention) = 7% 
 
  
Kane SP. Sample Size Calculator. ClinCalc: http://clincalc.com/stats/samplesize.aspx. Updated July 1, 
2017. Accessed August 24, 2018. 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
Page 18 of 27 
9.2 
Population to be analysed 
Every patient presenting for renal transplant that meets the criteria for inclusion and exclusion will 
included for intention to treat analysis. Secondary analysis as per protocol will also be performed. 
9.3 
Statistical Analysis Plan  
Statistical analysis will be pre-specified and conducted according to both principles of intention of treat 
and per-protocol analysis, using SPSS version 20 (IBM, Armonk, NY, USA). Each incision will be 
randomized to the Prevena or standard dressing group. In the case that a patient requires bilateral 
incisions, both incisions will be allocated to the same treatment arm and counted as a single incision. 
Baseline characteristics of the two groups will be recorded and compared using Student’s t-test and chi-
square test for continuous and discrete data respectively. The primary outcome, the proportion of 
wound complications, will be compared between the Prevena and standard dressing groups using a chi-
square test without Yates’ continuity correction with a two-sided alpha of 0.05 at the final analysis 
using the Peto approach to preserve the overall significance level of 0.05 (23). An absolute risk 
increase/reduction for wound complications will be presented for the use of Prevena, as well as the 
number needed to treat in order to prevent specific wound complications. Patients lost to follow-up 
will be used in an intention-to-treat analysis with last observation carried forward.  
 
The secondary outcome of identification of risk factors for wound complications will be assessed by 
multiple logistic regression of collected variables to assess their odds ratio. To prevent overfitting with 
the selected sample size, variables will be stepwise selected and also assessed for multicollinearity with 
the significance level of the dependent variables adjusted for multiplicity.  Secondary outcomes will be 
compared between groups using a chi-square or Fisher’s test for reoperation rate and delayed graft 
function and t-test for continuous variables, including the pain scale and quality of life. Non-normally 
distributed continuous variables will be tested for and compared using the Mann–
Whitney U test. Survival analysis will be performed for allograft survival time with subjects without 
events censored at the 90 day final observation. A p value of less than 0.05 will be considered 
significant for the secondary outcomes and all tests will be two-sided. 
9.4 
Interim Analyses  
Interim review of recruitment will occur at the 6 month period, and interim analysis of preliminary data 
will occur at the 1 year mark. Sample size estimates will be reassessed given actual rates of enrolment 
after the 6 month period to ensure that the a priori sample size calculated is realistic, and the trial may 
be extended to allow for adequate patient recruitment. The trial will not be stopped for superiority 
reasons unless the adverse event rate and safety of the product is determined to be significant. 
Significance of the primary outcome will be assessed with an interim stopping level of p=0.001 using the 
Peto approach. (23) 
10 DATA MANAGEMENT 
 
10.1 
Data Collection  
Study data will be collected by study investigators using paper and electronic study data collection 
forms, the hospital based patient electronic medical record, and managed using REDCap electronic data 
capture tools hosted at Royal North Shore Hospital. REDCap (Research Electronic Data Capture) is a 
secure, web-based application designed to support data capture for research studies, providing: 1) an 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
Page 19 of 27 
intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export 
procedures; 3) automated export procedures for seamless data downloads to common statistical 
packages; and 4) procedures for importing data from external sources. (19) Photos of patients wounds 
will be uploaded to REDCap using the image upload survey tool, and should be taken from 20-30cm 
above the wound with a mobile phone utilising the REDCap mobile phone app. Wounds will not be 
marked or identified with unique patient identifiers, so care must be taken to ensure the photo is 
uploaded for the correct patient. 
 
10.2 
Data Storage 
All electronic data will be stored on the secure online REDCap database at Royal North Shore Hospital. 
Only investigators and study staff will have their own password for access to this database. Passwords 
for the logins must not be shared, every person intending to enter data must contact the study 
coordinator at Royal North Shore Hospital to obtain their own log in. Any physical data will be stored 
within a locked room within the Research Units at each site and only study investigators will have 
access to this room.  
10.3 
Data Confidentiality  
Re-identifiable coded data will be stored on our secure online REDCap database, accessible only by 
study investigators. Each site will be able to see only their own data except for Royal North Shore 
Hospital who will be managing the data. Relevant codes will be encrypted and stored on a hard drive in 
a locked room within Research Units at each site and only investigators will have access this room. The 
method of coding and data abstraction will be site specific, but controlled by the study investigators at 
RNSH. 
10.4 
Study Record Retention 
After analysis of this data and the end of patient follow-up all electronic data from Royal North Shore 
Hospital, Royal Prince Alfred Hospital and Westmead Hospital will  be stored securely at Royal North 
Shore Hospital in the Vascular Surgery Research Office and destroyed after 15 years in accordance with 
the Australian Code for the responsible conduct of Research, TGA ICH – GCP and the National 
Statement on Ethical conduct in Human Research. 
11 ADMINISTRATIVE ASPECTS 
 
11.1 
Independent HREC approval 
This study has been approved by the Sydney Local Health District HREC, reference number: X18-0513
 
 
 
11.2 
Amendments to the protocol 
Any amendments will be submitted to the HREC for review prior to implementation as per HREC 
guidelines. 
11.3 
Protocol deviations 
Any protocol deviations will be submitted to the HREC for review. 
11.4 
Participant reimbursement 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
Page 20 of 27 
Participants will not be reimbursed in this study. 
11.5 
Financial disclosure and conflicts of interest 
Nil disclosures or conflicts of interest 
12 USE OF DATA AND PUBLICATIONS POLICY 
 
Intention is to publish study results in a peer-reviewed academic journal. Study participants will be 
informed that academic journals are accessible to the public, and all published patient data associated 
with this study will be de-identified to ensure patient confidentiality. 
13 REFERENCES 
 
(1)Shrestha A, Shrestha A, Basarab-Horwath C, McKane W, Shrestha B, Raftery A. Quality of life 
following live donor renal transplantation: a single centre experience. Ann Transplant 2010; 15: 5-10 
[PMID: 20657513]) 
 
(2)Stephan RN, Munschauer CE, Kumar MS. Surgical wound infection in renal transplantation: outcome 
data in 102 consecutive patients without perioperative systemic antibiotic coverage. Arch Surg 1997: 
132: 1315.)). 
 
(3) Mehrabi A, Fonouni H, Wente M, Sadeghi M, Eisenbach C, Encke J, Schmied BM, Libicher M, Zeier M, 
Weitz J, Buchler MW, Schmidt J. Wound complications following kidney and liver transplantation. Clin 
Transplant 2006: 20 (Suppl. 17): 97–110.ªBlackwell Munksgaard, 2006 
 
(4) Anstead GM. Steroids, retinoids, and wound healing. Adv Wound Care 1998: 11: 277 
 
(5)Obesity and overweight. World Health Organisation. Updated March 2011. 
http://www.who.int/mediacentre/factsheets/fs311/en/. 
 
(6)  Lafranca, J. A., IJermans, J. N., Betjes, M. G., & Dor, F. J. (2015). Body mass index and outcome in 
renal transplant recipients: a systematic review and meta-analysis. BMC medicine, 13(1), 111 
(7)Gislason H, Soreide O, Viste A. Wound complications after major gastrointestinal operations, the 
surgeon as a risk factor. Dig Surg 1999: 16: 512.) 
 
(8)Santangelo M, De Rosa P, Spiezia S et al. Healing of surgical incision in kidney transplantation: a 
single transplant center’s experience. Transplant Proc 2006: 38: 1044 
 
(9) Suissa D, Danino A, Nikolis A. Negative-pressure therapy versus standard wound care: A meta-
analysis of randomized trials. Plast Reconstr Surg. 2011;128:498e–503e. 
 
(10) Semsarzadeh, N. N., Tadisina, K. K., Maddox, J., Chopra, K., & Singh, D. P. (2015). Closed incision 
negative-pressure therapy is associated with decreased surgical-site infections: a meta-analysis. Plastic 
and reconstructive surgery, 136(3), 592-602 
(11) Hyldig N, Birke-Sorensen H, Kruse M, Vinter C, Joergensen JS, Sorensen JA, Mogensen O, Lamont 
RF, Bille C. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg 
2016; 103: 477-486 [PMID: 26994715 DOI: 10.1002/bjs.10084] 
 

 
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Protocol V2, dated 21 December 2018 
 
Page 21 of 27 
[12] Atkins BZ, Wooten MK, Kistler J, Hurley K, Hughes GC, Wolfe WG. Does negative pressure wound 
therapy have a role in preventing poststernotomy wound complications? Surg Innov 2009;16:140e6.. 
 
[13] Gomoll AH, Lin A, Harris MB. Incisional vacuum-assisted closure therapy. J Orthop Trauma 
2006;20:705e9. 
 
(14) Chopra, K., Gowda, A. U., Morrow, C., Luther Holton, I. I. I., & Singh, D. P. (2016). The economic 
impact of closed-incision negative-pressure therapy in high-risk abdominal incisions: a cost-utility 
analysis. Plastic and reconstructive surgery, 137(4), 1284-1289) 
(15) Bozkurt B, Tokac M, Dumlu EG, Yalcin A, Kilic M. Our First Experience With Negative Pressure 
Incision Management System Implemented on the Clean Surgical Incision in the Renal Transplantation 
Recipient: A Case Report. Transplant Proc 2015; 47:1515-1517 [PMID: 26093755 DOI: 
10.1016/j.transproceed.2015.04. 
057] 
(16) Shrestha, B. M. (2016). Systematic review of the negative pressure wound therapy in kidney 
transplant recipients. World journal of transplantation, 6(4), 767 
(17) Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site 
infections, 1992; A modification of CDC definitions of surgical wound infections. Infection Control Hosp 
Epidemiol. 1992; 13 606-608. 
 
(18) Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, 
Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for 
providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377- 
 
(19) WMA World Medical Association. World medical association declaration of helsinki:Ethical 
principles for medical research involving human subjects. JAMA 2013 November 27;310(20):2191-4. 
 
(20) International Conference on Harmonization, ICH. Guideline for Good Clinical 
Practice - Ich Harmonized Tripartite Guideline. ICH / GCP E6 (R1). [Accessed 16th May 2012]. 10-6-1996. 
Federal Register, FDA. Ref Type: Generic 
 
(21) ISO International Organization for Standardization. ISO 14155:2011 Clinical 
investigation of medical devices for human subjects - Good clinical practice. 2011. 
 
(22) Wittes, J. (2002). Sample size calculations for randomized controlled trials. Epidemiologic 
reviews, 24(1), 39-53. 
(23) Schulz, K. F., & Grimes, D. A. (2005). Multiplicity in randomised trials II: subgroup and interim 
analyses. The Lancet, 365(9471), 1657-1661. 
 
 
 
 
 
 
 
 
 
 
 

 
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Page 22 of 27 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
14 APPENDICES (A – G) 
 
Appendix A. Classification of wound complications (adapted from Mehrabi et al (3), CDC guidelines; 
Horan et al (17)) 
 
1) Superficial wound dehiscence: A separation of the superficial layers (skin and subcutaneous tissues) 
in the absence of documented incisional infection. 
 
(2) Deep wound dehiscence or fascial dehiscence: The separation of the muscular fascia of the incision 
in the postoperative period, requiring operative repair. 
 
(3) Perigraft fluid collection/seroma: detected by clinical suspicion and confirmed by ultrasound or 
CT/MRI. Perigraft fluid collections are diagnosed when the location of the fluid is deep to the muscular 
fascia. A seroma is diagnosed when there is a sterile fluid collection superficial to the muscular fascia. 
Urine leaks are also recorded, and fluids can be identified through pathology testing. 
 
(4) Superficial wound infection: Diagnosed within 30 days of operation, limited to skin or subcutaneous 
tissue, and at least one of the following should be present:  
(a) purulent drainage from the superficial incision;  
(b) a sign or symptom of infection, such as pain, tenderness, heat, or swelling. 
 (c) the diagnosis of superficial wound infection is confirmed by the surgeon.  
 
(5) Deep wound infection: Diagnosed within 30 days of operation, involvement of the fascial or 

 
IMPART TRIAL  
Protocol V2, dated 21 December 2018 
 
Page 23 of 27 
muscular layers, and at least one of the following should be present: 
(a) purulent drainage  from the deep incision;  
(b) spontaneous dehiscence while the patient has fever (>38_C), localized pain, or tenderness;  
(c) An abscess is found on direct examination, on reoperation, or by radiologic examination; the content 
contains pus, and the culture yielded one or more micro-organisms;  
(d) the diagnosis of deep incisional infection is confirmed by the surgeon. 
 
(6) Cellulitis: Diagnosed by presence of erythema, tenderness, swelling and warmness of the skin 
surrounding the wound.  
 
(7) Lymphocele: Deep lymphatic collections with pseudomembrane formation. The diagnosis is made by 
ultrasonography, CT or MRI and confirmed by needle aspiration of the lymphocele content and 
measuring the creatinine concentration or finding lymphatic components. 
 
(8) Prolonged wound drainage: Defined as continuous fluid discharge greater than 50 mL/d through the 
drain or wound for more than seven days after transplantation during the first hospitalization. Fluids 
are identified by pathological testing at clinician discretion 
 
 
 
 
Appendix B:  Modified ASEPSIS Wound assessment form  
 
Wound Assessment for patient Study ID _________________ (de-identify patient to assessor)   
Assessor________________________ 
Wound site (please circle): Right Iliac Fossa/ Left Iliac Fossa/ Midline  
Wound Length __________________ 
Dressing type __________________ (blinded to assessor)  
 
Day ___________ post op  
Date /Time _______________ 
points 
Skin  
 Intact  
 Minor/small separation or wound breakdown  
 Major / complete wound breakdown  
 
 
Separation of Deep Tissue 
 0% of wound affected  
 
0 

 
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Protocol V2, dated 21 December 2018 
 
Page 24 of 27 
 1-20%  
 20-39% 
 40-59% 
 60-79% 
 >/= 80% 
2 
4 
6 
8 
10 
Fascia intact  
 Yes  
 No  
 
For Wound Dehiscence  
Size: length x width x depth (mm) _______________________________________ 
 
Signs of Inflammation  
 
Erythema  
 0%  
 1-20% of wound affected 
 20-39%  
 40-59% 
 60-79% 
 >/= 80% 
 
0 
1 
2 
3 
4 
5 
Pain at wound site 
 Yes  
 No  
 
Exudate  
 No (Dry) 
 Yes (Moist) 
 
0 
Exudate Colour  
 Serous (clear)  
 Sanguineous (bloody)  
 Serosanguinous (thin/pink)  
 Purulent (thick opaque/green/brown) 
 
If serous: Exudate volume  
 Scant (1-20% wound moist/ bandage most) 
 Small/minimal (20-39%)  
 Moderate (40-59%) 
 Large (60-79%) 
 Very large/Copious tissue filled with fluid (>80% ) 
 
2 
4 
6 
8 
10 
If purulent: exudate volume  
 Scant (1-20% wound moist/ bandage most) 
 Small/minimal (20-39%)  
 Moderate (40-59%) 
 Large (60-79%) 
 Very large/Copious tissue filled with fluid (>80%) 
 
 
2 
4 
6 
8 
10 

 
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Protocol V2, dated 21 December 2018 
 
Page 25 of 27 
Odour  
 No odour  
 Malodorous  
 
Wound base  
 Healthy – Red  
 Purple – engorged  
 Yellow – slough  
 Green – infected 
 Black – necrotic  
Surrounding skin  
 Healthy  
 Oedematous  
 Swelling 
 Macerated  
 Excoriated  
 Rash  
 
 
 
 
Treatment  
 
Isolation of pathogenic organism/bacteria on wound swab 
 No 
 Yes (organism______________________________________________________________) 
 
0 
10 
Antibiotics given  
 No 
 Yes (duration____________________________________________________________days) 
 
0 
10 
Drainage of fluid / purulent fluid at bedside 
 Yes  
 No 
 
0 
5 
Debridement of wound under general anaesthetic  
 Yes  
 No 
 
0 
10 
Inpatient stay  
 Not prolonged  
 Prolonged (>14 days)  
 Readmitted  
 
0 
5 
 
 
 
 
 

 
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Appendix D. : EQ – 5D- 5L (see attached) 
 
 
Appendix E. POSAS Observer scale (see attached) 
 
 
 
 

 
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Appendix F. POSAS Patient scale (see attached) 
 
 
Appendix G. VAS/NRS (see attached)