POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant:a Randomized Controlled Trial

Not Applicable

• Conditions: Liver Transplant; Complications
• Interventions: Device: Negative-pressure wound therapy (PICO)

• Registration Number: NCT04039659
• Lead Sponsor: Hospital Universitario Virgen de la Arrixaca

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-06-10
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-29
• Last Update Submitted: 2019-07-29
• Study First Posted: 2019-07-31
• Last Update Posted: 2019-07-31
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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.

Exclusion Criteria

• To have been rejected for liver transplantation by said committee

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICO group	Negative-pressure wound therapy (PICO)	Patients will carry the device for 7 days uninterrupted until its withdrawal.

Primary Outcome Measures

Name	Time	Method
Incidence rate of surgical site	30 days after surgery	Any complication of surgical site will be registered

Secondary Outcome Measures

Name	Time	Method
Nosocomial infection rate	30 days after surgery (3rd, 7th, 15th and 30th post trasplant)	To verify the change in rates of nosocomial infections in the context of liver transplantation.
Quality of life of transplantation patient	6 months	We will use Cardiff Wound Impact Schedule to evaluate the possible improvement in the quality of life of transplantation patients derived from the decrease in the requirement of health resources.

Trial Locations

Locations (1)

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain