Negative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant

Study Overview
=================
Brief Summary
-----------------
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. 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 re-operation, 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.

Official Title
-----------------
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

Conditions
-----------------
Wound Complication

Intervention / Treatment
-----------------
* Device: Closed Incision Negative Pressure Wound Therapy (Prevena)
* Other: Control - Standard Dressings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant: is an adult ≥ 18 years old, regardless of comorbidities or BMI is able to provide their own informed consent will undergo open renal transplant surgery, including those who undergo dual renal transplant or simultaneous pancreas transplant. will require a surgical incision(s) likely to be able to be covered completely by one or more Prevena Incision Management Systems. is willing and able to return for the required follow up assessments. 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 Exclusion Criteria: The participant: has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives. 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. Is not willing to comply with the study procedures. Has an unforseen intraoperative event mandating additional management including a planned re-exploration. Has obvious intraoperative contamination of the surgical site. Has a wound with suspected ischaemia in the incision area, or inadequate haemostasis. 7. Requires drains that cannot be covered by the Prevena dressing.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed Incision Negative Pressure Wound Therapy (Prevena)<br>Patients are randomised intra-operatively to either Prevena or standard dressings as long as inclusion criteria are met, and no exclusion criteria met. This is left in-situ for 7 days, unless clinically indicated. | Device: Closed Incision Negative Pressure Wound Therapy (Prevena)<br>* Closed Incision Negative Pressure Wound Device (Prevena) applied to closed wound at completion of operation.<br>|
| Active Comparator: Standard Dressings<br>Patients are randomised intra-operatively to either Prevena or standard dressings as long as inclusion criteria are met, and no exclusion criteria met. Standard care wound dressings are applied for patients in this arm. These are changed as clinically appropriate whilst in hospital. | Other: Control - Standard Dressings<br>* Standard wound dressings applied to closed wound at completion of operation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Complications | Any wound infection, wound dehiscence, wound haematoma, wound collection or re-operation due to the above following renal transplantation. | 0-90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Comparison of length of hospital stay between the two groups | 0-90 days | 
| Graft function (creatinine) | Comparison of markers of graft function (creatinine) between the two groups | 0-90 days | 
| Delayed graft function | Number of patients requiring ongoing dialysis in each group. | 0-90 days | 
| Pain score (numeric rating scale) | Comparison of patient reported post-operative wound pain scale between groups utilising a generic numeric rating scale (NRS) for pain. A numeric rating scale is a way a patient can report pain from 0-10, 0 being no pain, 10 being extreme pain. Minimum score is 0, maximum score is 10. It is better to have less pain, therefore 0 is the best score possible. | 0-90 days | 
| Scar quality (The Patient and Observer Scar Assessment Scale: POSAS) | Comparison of observer and patient reported scarring utilising the POSAS (The Patient and Observer Scar Assessment Scale: POSAS). The observer questions are listed below and are each scored from 1 to 10, 1 being normal skin, 10 being worst scar imaginable. Vascularity Pigmentation Thickness Relief Pliability Surface area Overall opinon of scar The patient scale questions are listed below and are each scored from 1 to 10, 1 being normal skin, 10 being the worst scar imaginable. 1. Has the scar been painful the past few weeks? 2. Has the scar been itching the past few weeks? 3. Skin Colour 4. Skin stiffness 5. Skin Thickness 6. Scar irregularity 7. Overall opinion of scar The total score for patient and observer subscales is out of 70 each, for a combined total of 140 (both subscales added together). The minimum possible score is 14 and the maximum score is 140. | 0-90 days | 
| Quality of Life (EQ-5D-5L score) | Comparison of quality of life scores reported by patients in each group using the EQ-5D-5L quality of life scale. The scale is split into 5 subscales; mobility self-care usual activities pain/discomfort anxiety/depression. Each subscale is ranked from 1 to 5, 1 being nil pain/quality of life disturbance, 5 being extreme pain/quality of life disturbance. The subscales are reported separately and are not combined. The patient also completes an overall health assessment from 0-100, 0 being the worst health imaginable, 100 being the best health imaginable. This is also reported and analysed separately. | 0-90days | 
| Graft function (estimated glomerular filtration rate) | Comparison of markers of graft function (creatinine) between the two groups | 0-90days | 
| ASEPSIS wound score | Wound scoring by a wound assessor. Scored: 0-5 for serous discharge and erythema (each), 0 being nil, 5 being significant. 0-10 for purulent exudate and separation of deep tissues (each), 0 being nil, 10 being significant. Isolation of bacteria on wound swap, 0 for no bacterial, 10 for bacterial growth. Further scores of 10 (for antibiotic usage), 5 (for drainage of pus under local anaesthesia), 10 (for debridement under general anaesthesia) and 5 (for prolonged inpatient stay >14 days). All scores are added together for a total of 70, 0 being the minimum possible (best) score and 70 being the maximum possible (worst) score. | 0-90days |