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临床试验/NCT04039659
NCT04039659Unknown不适用

POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant (PONILITRANS Study): a Randomized Controlled Trial

Hospital Universitario Virgen de la Arrixaca2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

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

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

No Intervention

Patients will be cured with dressings wound everyday or before if there are complications in surgical incisions.

PICO group

Active Comparator

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

发起方
Hospital Universitario Virgen de la Arrixaca
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Delegido Garcia

Principal investigator

Hospital Universitario Virgen de la Arrixaca

研究点 (2)

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