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

Virgen de la Arrixaca University Clinical Hospital (HCUVA)

Status: Unknown

Conditions: Liver Transplant; Complications

Treatments: Device: Negative-pressure wound therapy (PICO)

Study type: Interventional

Funder types: Other

Identifiers

NCT04039659

2019-1-6-HCUVA

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Control Group

No Intervention group

Description:

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

PICO group

Active Comparator group

Description:

Patients will carry the device for 7 days uninterrupted until its withdrawal.

Treatment:

Device: Negative-pressure wound therapy (PICO)