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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Transplant; Complications

Intervention / Treatment
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* Device: Negative-pressure wound therapy (PICO)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 over the wound. After 7 days, the PICOⓇ device will be removed and both preoperative and postoperative variables will be studied.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients will be cured with dressings wound everyday or before if there are complications in surgical incisions. | |
| Active Comparator: PICO group<br>Patients will carry the device for 7 days uninterrupted until its withdrawal. | Device: Negative-pressure wound therapy (PICO)<br>* After the selection of patients and the signing of the consent, patients will be randomized and the device will be placed to those who belong to the PICO group in the operating room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of surgical site | Any complication of surgical site will be registered | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of transplantation patient | 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. | 6 months | 
| Nosocomial infection rate | To verify the change in rates of nosocomial infections in the context of liver transplantation. | 30 days after surgery (3rd, 7th, 15th and 30th post trasplant) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound complications, negative-pressure wound therapy