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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Wound Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Closed Incision Negative Pressure Wound Therapy (Prevena)

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.

Group Type EXPERIMENTAL

Closed Incision Negative Pressure Wound Therapy (Prevena)

Intervention Type DEVICE

Closed Incision Negative Pressure Wound Device (Prevena) applied to closed wound at completion of operation.

Standard Dressings

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.

Group Type ACTIVE_COMPARATOR

Control - Standard Dressings

Intervention Type OTHER

Standard wound dressings applied to closed wound at completion of operation.

Interventions

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Closed Incision Negative Pressure Wound Therapy (Prevena)

Closed Incision Negative Pressure Wound Device (Prevena) applied to closed wound at completion of operation.

Intervention Type DEVICE

Control - Standard Dressings

Standard wound dressings applied to closed wound at completion of operation.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No