NCT03948412

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Royal North Shore Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Complication

Interventions

Type	Name	Description
DEVICE	Closed Incision Negative Pressure Wound Therapy (Prevena)	Closed Incision Negative Pressure Wound Device (Prevena) applied to closed wound at completion of operation.
OTHER	Control - Standard Dressings	Standard wound dressings applied to closed wound at completion of operation.

Timeline

• Start date: 2019-05-10
• Primary completion: 2021-05-01
• Completion: 2021-09-01
• First posted: 2019-05-14
• Last updated: 2019-05-14

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study