Wound Complication Clinical Trial
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
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.
n/a
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