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ENROLLING BY INVITATION
NCT07744230

Prometheus: Prophylactic Mesh After OLtx for Hernia Reduction Study.

Sponsor: University of Rome Tor Vergata

View on ClinicalTrials.gov

Summary

A multicenter prospective, consecutive case series study, on the use of a bio-absorbable mesh for prevention of incisional hernia, in high risk patients, after orthotopic liver transplantation.

Official title: Prometheus: Prophylactic Mesh After OLtx for Hernia Reduction Study. A Multicenter Prospective, Consecutive Case Series Study, on the Use of a Bio-absorbable Mesh for Prevention of Incisional Hernia, in High Risk Patients, After Orthotopic Liver Transplantation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-05-15

Completion Date

2029-05-30

Last Updated

2026-08-04

Healthy Volunteers

No

Interventions

PROCEDURE

mesh

The technique used for surgical incision and for abdominal wall closure will follow each participating center policy. A slowly absorbable material will be used for closure by all centers. After conventional closure a bio-absorbable mesh will be placed in a onlay position (PHASIX - C. R. Bard, Inc/Davol Inc, Warwick, RI). The above mentioned meshes are currently available in the participating centers. The surgeons will be specifically trained in using a prophylactic onlay mesh. An overlapping of 3 cm must be obtained on every side of surgical incision. Fixation methods allowed: interrupted long- term absorbable suture. Subcutaneous and skin closure following center practice. The operating surgeon can decide for the placement of a subcutaneous drain if necessary.

Locations (1)

Policlinico Tor Vergata

Rome, Lazio, Italy