NCT04039659

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Hospital Universitario Virgen de la Arrixaca · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplant; Complications

Interventions

Type	Name	Description
DEVICE	Negative-pressure wound therapy (PICO)	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.

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2019-07-31
• Last updated: 2019-07-31

Locations

1 site across 1 country: Spain