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
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Wound Complications
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •Requires drains that cannot be covered by the Prevena dressing.
研究组 & 干预措施
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.
干预措施: Closed Incision Negative Pressure Wound Therapy (Prevena) (Device)
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.
干预措施: Control - Standard Dressings (Other)
结局指标
主要结局
Wound Complications
时间窗: 0-90 days
Any wound infection, wound dehiscence, wound haematoma, wound collection or re-operation due to the above following renal transplantation.
次要结局
- Graft function (estimated glomerular filtration rate)(0-90days)
- Length of hospital stay(0-90 days)
- Scar quality (The Patient and Observer Scar Assessment Scale: POSAS)(0-90 days)
- Graft function (creatinine)(0-90 days)
- Delayed graft function(0-90 days)
- Pain score (numeric rating scale)(0-90 days)
- Quality of Life (EQ-5D-5L score)(0-90days)
- ASEPSIS wound score(0-90days)
研究者
David Herlihy
Vascular Surgery Registrar
Royal North Shore Hospital