POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant (PONILITRANS Study): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Incidence rate of surgical site
研究概览
简要总结
This study is to evaluate whether the prophylactic use of a negativa pressure therapy device (PICOⓇ) on the closed wound of the liver transplant, reduces the postoperative complications of surgical wounds, compared to the use of dressings conventional postoperative
详细描述
Postoperative complications of surgical wounds are frequent after surgical procedures, even more in the context of liver transplantation given the necessary immunosuppression, high surgical time, high hospital stay and intensive care, politransfusions, etc. Negative pressure therapy is well established for the treatment of open wounds, its use having been recently indicated on closed surgical wounds. The evidence to justify this intervention is still limited.
The objective of our clinical trial is to evaluate whether the prophylactic use of a negative pressure therapy device (PICOⓇ) on the closed wound of the liver transplant, reduces the postoperative complications of surgical wounds, compared to the use of dressings conventional postoperative After signing the informed consent of those patients who meet the inclusion criteria, they will be randomized into two groups to install the PICOⓇ device or conventional dressings on the wound. After 7 days, the PICOⓇ device will be removed and both preoperative and postoperative variables will be studied in terms of incidence of surgical site events, stay, etc.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged between 18 and 70 years included in the waiting list for liver transplantation by the committee of the Virgen de la Arrixaca University Hospital.
排除标准
- •To have been rejected for liver transplantation by said committee
研究组 & 干预措施
Control Group
Patients will be cured with dressings wound everyday or before if there are complications in surgical incisions.
PICO group
Patients will carry the device for 7 days uninterrupted until its withdrawal.
干预措施: Negative-pressure wound therapy (PICO) (Device)
结局指标
主要结局
Incidence rate of surgical site
时间窗: 30 days after surgery
Any complication of surgical site will be registered
次要结局
- Nosocomial infection rate(30 days after surgery (3rd, 7th, 15th and 30th post trasplant))
- Quality of life of transplantation patient(6 months)
研究者
Ana Delegido Garcia
Principal investigator
Hospital Universitario Virgen de la Arrixaca
