Liver Transplant; Complications
Conditions
Keywords
wound complications, negative-pressure wound therapy
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.
Interventions
DEVICENegative-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.
Sponsors
Hospital Universitario Virgen de la Arrixaca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of surgical site | 30 days after surgery | Any complication of surgical site will be registered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Spain
Contacts
Primary ContactVíctor López López
Backup ContactAna Delegido García
Outcome results
None listed