NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Wound dehiscence
研究概览
简要总结
This is a prospective study involving patients undergoing open renal transplant. Renal transplant recipients were randomly divided into two groups: the NPWT group, which received NPWT, and the Standard group, which received standard wound dressings.
详细描述
This is a prospective study involving patients undergoing open renal transplant between January 2023 and August 2024. Pediatric patients, those requiring surgical reinterventions within the first 3 postoperative months, and patients allergic to NPWT components were excluded from the study. Renal transplant recipients were randomly divided into two groups: the NPWT group, which received NPWT, and the Standard group, which received standard wound dressings. NPWT (PICO by Smith & Nephew) was applied intraoperatively at 80 mmHg and maintained for 7 days. Wound evaluations were performed at 7, 14, 30, and 90 days post-operatively. If dehiscence was present, it was classified as either deep or superficial based on the involvement of the aponeurosis. Patients were assessed for wound infection using the ASEPSIS score, pain with a visual analogue scale, and quality of life using the EQ-5D questionnaire. Scar healing was also evaluated at 30 and 90 days post-operatively with the POSAS score
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
- None
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
- •All patients submitted to kidney transplant
排除标准
- •Pediatric patients, those requiring surgical reinterventions within the first 90 days postoperative, patients allergic to NPWT components, orthotopic transplant
研究组 & 干预措施
NPWT group
Patients who received negative pressure wound therapy
干预措施: NWPT group (Device)
Standard group
Patients who received standard dressing
结局指标
主要结局
Wound dehiscence
时间窗: First 90 days after surgery
Wound dehiscence - superficial or deep
次要结局
- Pain associated with incision(First 90 days after surgery)
- Wound infection(First 90 days after surgery)
- Quality of life associated with incision(First 90 days after surgery)
- Scar healing(First 90 days after surgery)
研究者
Alberto Costa Silva
Principal Investigator
Centro Hospitalar De São João, E.P.E.