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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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RNSH-VASC-2019-1
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Universal Trial Number (UTN)
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Trial acronym
IMPART
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Wound Complication
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Condition category
Condition code
Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Wound Complications
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Assessment method [1]
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Any wound infection, wound dehiscence, wound haematoma, wound collection or re-operation due to the above following renal transplantation.
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Timepoint [1]
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0-90 days
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Secondary outcome [1]
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Length of hospital stay
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Assessment method [1]
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Comparison of length of hospital stay between the two groups
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Timepoint [1]
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0-90 days
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Secondary outcome [2]
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Graft function (creatinine)
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Assessment method [2]
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Comparison of markers of graft function (creatinine) between the two groups
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Timepoint [2]
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0-90 days
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Secondary outcome [3]
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Delayed graft function
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Assessment method [3]
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Number of patients requiring ongoing dialysis in each group.
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Timepoint [3]
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0-90 days
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Secondary outcome [4]
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Pain score (numeric rating scale)
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Assessment method [4]
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Comparison of patient reported post-operative wound pain scale between groups utilising a generic numeric rating scale (NRS) for pain.
A numeric rating scale is a way a patient can report pain from 0-10, 0 being no pain, 10 being extreme pain. Minimum score is 0, maximum score is 10. It is better to have less pain, therefore 0 is the best score possible.
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Timepoint [4]
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0-90 days
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Secondary outcome [5]
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Scar quality (The Patient and Observer Scar Assessment Scale: POSAS)
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Assessment method [5]
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Comparison of observer and patient reported scarring utilising the POSAS (The Patient and Observer Scar Assessment Scale: POSAS).
The observer questions are listed below and are each scored from 1 to 10, 1 being normal skin, 10 being worst scar imaginable.
Vascularity
Pigmentation
Thickness
Relief
Pliability
Surface area
Overall opinon of scar The patient scale questions are listed below and are each scored from 1 to 10, 1 being normal skin, 10 being the worst scar imaginable.
1. Has the scar been painful the past few weeks? 2. Has the scar been itching the past few weeks? 3. Skin Colour 4. Skin stiffness 5. Skin Thickness 6. Scar irregularity 7. Overall opinion of scar The total score for patient and observer subscales is out of 70 each, for a combined total of 140 (both subscales added together). The minimum possible score is 14 and the maximum score is 140.
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Timepoint [5]
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0-90 days
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Secondary outcome [6]
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Quality of Life (EQ-5D-5L score)
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Assessment method [6]
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Comparison of quality of life scores reported by patients in each group using the EQ-5D-5L quality of life scale.
The scale is split into 5 subscales;
mobility
self-care
usual activities
pain/discomfort
anxiety/depression. Each subscale is ranked from 1 to 5, 1 being nil pain/quality of life disturbance, 5 being extreme pain/quality of life disturbance. The subscales are reported separately and are not combined.
The patient also completes an overall health assessment from 0-100, 0 being the worst health imaginable, 100 being the best health imaginable. This is also reported and analysed separately.
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Timepoint [6]
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0-90days
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Secondary outcome [7]
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Graft function (estimated glomerular filtration rate)
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Assessment method [7]
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Comparison of markers of graft function (creatinine) between the two groups
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Timepoint [7]
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0-90days
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Secondary outcome [8]
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ASEPSIS wound score
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Assessment method [8]
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Wound scoring by a wound assessor.
Scored:
0-5 for serous discharge and erythema (each), 0 being nil, 5 being significant. 0-10 for purulent exudate and separation of deep tissues (each), 0 being nil, 10 being significant.
Isolation of bacteria on wound swap, 0 for no bacterial, 10 for bacterial growth.
Further scores of 10 (for antibiotic usage), 5 (for drainage of pus under local anaesthesia), 10 (for debridement under general anaesthesia) and 5 (for prolonged inpatient stay >14 days).
All scores are added together for a total of 70, 0 being the minimum possible (best) score and 70 being the maximum possible (worst) score.
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Timepoint [8]
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0-90days
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
10/05/2019
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2021
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal North Shore Hospital - Sydney
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Recruitment postcode(s) [1]
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2065 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Royal North Shore Hospital
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03948412
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Vikram Puttaswamy, MBBS
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Address
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Vascular Surgeon
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Linda Pallot
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Address
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Country
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Phone
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+61294631767
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03948412
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