Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-07-19 @ 4:58 AM
Study NCT ID:
NCT04039659
Status:
UNKNOWN
Last Update Posted:
2019-07-31
First Post:
2019-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant:a Randomized Controlled Trial
Sponsor:
Hospital Universitario Virgen de la Arrixaca
Organization:
Study Overview
Official Title:
POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant (PONILITRANS Study): a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PONILITRANS
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: