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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03948412




Registration number
NCT03948412
Ethics application status
Date submitted
5/05/2019
Date registered
14/05/2019
Date last updated
14/05/2019

Titles & IDs
Public title
Negative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant
Scientific 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
Secondary ID [1] 0 0
RNSH-VASC-2019-1
Universal Trial Number (UTN)
Trial acronym
IMPART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound Complication 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Closed Incision Negative Pressure Wound Therapy (Prevena)
Other interventions - Control - Standard Dressings

Experimental: 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.

Active comparator: 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.


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

Other interventions: Control - Standard Dressings
Standard wound dressings applied to closed wound at completion of operation.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Wound Complications
Timepoint [1] 0 0
0-90 days
Secondary outcome [1] 0 0
Length of hospital stay
Timepoint [1] 0 0
0-90 days
Secondary outcome [2] 0 0
Graft function (creatinine)
Timepoint [2] 0 0
0-90 days
Secondary outcome [3] 0 0
Delayed graft function
Timepoint [3] 0 0
0-90 days
Secondary outcome [4] 0 0
Pain score (numeric rating scale)
Timepoint [4] 0 0
0-90 days
Secondary outcome [5] 0 0
Scar quality (The Patient and Observer Scar Assessment Scale: POSAS)
Timepoint [5] 0 0
0-90 days
Secondary outcome [6] 0 0
Quality of Life (EQ-5D-5L score)
Timepoint [6] 0 0
0-90days
Secondary outcome [7] 0 0
Graft function (estimated glomerular filtration rate)
Timepoint [7] 0 0
0-90days
Secondary outcome [8] 0 0
ASEPSIS wound score
Timepoint [8] 0 0
0-90days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
10/05/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2021
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2065 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03948412
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vikram Puttaswamy, MBBS
Address 0 0
Vascular Surgeon
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Linda Pallot
Address 0 0
Country 0 0
Phone 0 0
+61294631767
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03948412