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

NCT03948412 | Unknown FDA Device

• 1 other identifier: RNSH-VASC-2019-1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Length of hospital stay

  0-90 days

• Graft function (creatinine)

  0-90 days

• Delayed graft function

  0-90 days

• Pain score (numeric rating scale)

  0-90 days

• Scar quality (The Patient and Observer Scar Assessment Scale: POSAS)

  0-90 days

Study Arms (2)

Closed Incision Negative Pressure Wound Therapy (Prevena)

EXPERIMENTAL

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)

Standard Dressings

ACTIVE COMPARATOR

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

Interventions

Closed Incision Negative Pressure Wound Therapy (Prevena) DEVICE

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

Closed Incision Negative Pressure Wound Therapy (Prevena)

Control - Standard Dressings OTHER

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

Standard Dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

RECRUITING

Study Officials

• Vikram Puttaswamy, MBBS

  Vascular Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Pallot

CONTACT

+61294631767; Linda.Pallot@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgery Registrar

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 14, 2019
• Study Start: May 10, 2019
• Primary Completion: May 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)