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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed Incision Negative Pressure Wound Therapy (Prevena) | Device | Closed Incision Negative Pressure Wound Device (Prevena) applied to closed wound at completion of operation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Wound Complications | Any wound infection, wound dehiscence, wound haematoma, wound collection or re-operation due to the above following renal transplantation. | 0-90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Comparison of length of hospital stay between the two groups | 0-90 days |
| Graft function (creatinine) | Comparison of markers of graft function (creatinine) between the two groups |
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Inclusion Criteria:
The participant:
Exclusion Criteria:
The participant:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Pallot | Contact | +61294631767 | Linda.Pallot@health.nsw.gov.au |
| Name | Affiliation | Role |
|---|---|---|
| Vikram Puttaswamy, MBBS | Vascular Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | Recruiting | Sydney | New South Wales | 2065 | Australia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2018 |
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| Control - Standard Dressings | Other | Standard wound dressings applied to closed wound at completion of operation. |
|
| 0-90 days |
| Delayed graft function | Number of patients requiring ongoing dialysis in each group. | 0-90 days |
| 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. | 0-90 days |
| 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.
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. | 0-90 days |
| 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;
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. | 0-90days |
| Graft function (estimated glomerular filtration rate) | Comparison of markers of graft function (creatinine) between the two groups | 0-90days |
| 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. | 0-90days |
| May 5, 2019 |
| Prot_SAP_000.pdf |