Back to resultsNegative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant (IMPART)
Primary Purpose
Wound Complication
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Closed Incision Negative Pressure Wound Therapy (Prevena)
Control - Standard Dressings
Sponsored by
About this trial
This is an interventional prevention trial for Wound Complication
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Sites / Locations
- Royal North Shore HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Closed Incision Negative Pressure Wound Therapy (Prevena)
Standard Dressings
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Wound Complications
Any wound infection, wound dehiscence, wound haematoma, wound collection or re-operation due to the above following renal transplantation.
Secondary Outcome Measures
Length of hospital stay
Comparison of length of hospital stay between the two groups
Graft function (creatinine)
Comparison of markers of graft function (creatinine) between the two groups
Delayed graft function
Number of patients requiring ongoing dialysis in each group.
Pain score (numeric rating scale)
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.
Scar quality (The Patient and Observer Scar Assessment Scale: POSAS)
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.
Quality of Life (EQ-5D-5L score)
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.
Graft function (estimated glomerular filtration rate)
Comparison of markers of graft function (creatinine) between the two groups
ASEPSIS wound score
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03948412
Brief Title
Negative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant
Acronym
IMPART
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2019 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal North Shore Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Closed Incision Negative Pressure Wound Therapy (Prevena)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Dressings
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Closed Incision Negative Pressure Wound Therapy (Prevena)
Intervention Description
Closed Incision Negative Pressure Wound Device (Prevena) applied to closed wound at completion of operation.
Intervention Type
Other
Intervention Name(s)
Control - Standard Dressings
Intervention Description
Standard wound dressings applied to closed wound at completion of operation.
Primary Outcome Measure Information:
Title
Wound Complications
Description
Any wound infection, wound dehiscence, wound haematoma, wound collection or re-operation due to the above following renal transplantation.
Time Frame
0-90 days
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Comparison of length of hospital stay between the two groups
Time Frame
0-90 days
Title
Graft function (creatinine)
Description
Comparison of markers of graft function (creatinine) between the two groups
Time Frame
0-90 days
Title
Delayed graft function
Description
Number of patients requiring ongoing dialysis in each group.
Time Frame
0-90 days
Title
Pain score (numeric rating scale)
Description
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.
Time Frame
0-90 days
Title
Scar quality (The Patient and Observer Scar Assessment Scale: POSAS)
Description
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.
Time Frame
0-90 days
Title
Quality of Life (EQ-5D-5L score)
Description
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.
Time Frame
0-90days
Title
Graft function (estimated glomerular filtration rate)
Description
Comparison of markers of graft function (creatinine) between the two groups
Time Frame
0-90days
Title
ASEPSIS wound score
Description
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.
Time Frame
0-90days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Pallot
Phone
+61294631767
Email
Linda.Pallot@health.nsw.gov.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vikram Puttaswamy, MBBS
Organizational Affiliation
Vascular Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Pallot
Phone
+61294631767
Email
Linda.Pallot@health.nsw.gov.au
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Negative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant
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