Clinical trial NCT03948412: Negative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Complication
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

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.
4. Has an unforseen intraoperative event mandating additional management including a planned re-exploration.
5. Has obvious intraoperative contamination of the surgical site.
6. Has a wound with suspected ischaemia in the incision area, or inadequate haemostasis. 7. Requires drains that cannot be covered by the Prevena dressing.

Primary outcomes:
measure: Wound Complications
timeFrame: 0-90 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 0-90 days
measure: Graft function (creatinine)
timeFrame: 0-90 days
measure: Delayed graft function
timeFrame: 0-90 days
measure: Pain score (numeric rating scale)
timeFrame: 0-90 days
measure: Scar quality (The Patient and Observer Scar Assessment Scale: POSAS)
timeFrame: 0-90 days
measure: Quality of Life (EQ-5D-5L score)
timeFrame: 0-90days
measure: Graft function (estimated glomerular filtration rate)
timeFrame: 0-90days
measure: ASEPSIS wound score
timeFrame: 0-90days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Vascular Surgeon
name: Vikram Puttaswamy, MBBS
role: PRINCIPAL_INVESTIGATOR
References: