Ventral Hernia Prevention After Liver Transplantation

Not Applicable

Terminated

• Conditions: Ventral Hernia; Liver Transplantation
• Interventions: Device: Phasix mesh

• Registration Number: NCT03222102
• Lead Sponsor: Medical University of Graz

Brief Summary

This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic, fully resorbable mesh "Phasix" in the course of liver transplantation.

Patients will be randomized in a 1:1 ratio to receive either Phasix mesh or standard surgery without the use of Phasix.

Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.

Detailed Description

Ventral hernia is a frequently occurring complication following liver transplantation, with a reported risk in the literature ranging from 5% to 25%.

This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic mesh "Phasix" in the course of liver transplantation.

PHASIX™ Mesh is a fully resorbable mesh implant prepared from poly-4-hydroxybutyrate (P4HB). Absorption of the mesh material occurs within 12 to 18 months.

Patients will be randomized in a 1:1 ratio to receive either Phasix mesh in the course of liver transplantation or standard surgery without the use of Phasix.

Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.

Study Timeline

• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-19
• Study Start: 2017-11-30
• Primary Completion: 2023-11-04
• Study Completion: 2023-11-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Age >18 years
• First transplantation
• Signed Informed Consent

Exclusion Criteria

• Combined transplantation
• Revisions after liver transplantation
• Patients who already received laparotomy or transverse upper laparotomy (longer than 15 cm)
• Preexisting abdominal wall hernia except umbilical hernia after liver transplantation
• Pregnant/lactating women
• Known allergies to tetracycline hydrochloride and kanamycin sulfate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phasix mesh	Phasix mesh	Phasix mesh will be affixed to the exposed fascia after closure of the Abdomen in the course of liver transplantation.

Primary Outcome Measures

Name	Time	Method
Incidence of ventral hernia	12 months after liver transplantation	Evaluated by ultra-sound imaging

Secondary Outcome Measures

Name	Time	Method
Hematoma	12 months after liver transplantation	Number of hematoma in the wound area, assessed by clinical evaluation
Wound healing disorders	12 months after liver transplantation	Presence of wound healing disorders in the wound area, assessed by clinical evaluation
Seroma	12 months after liver transplantation	Presence of seroma in the wound area, assessed by clinical evaluation
Infections	12 months after liver transplantation	Number of infections in the wound area, assessed by clinical evaluation

Trial Locations

Locations (1)

Medical University of Graz; Klin. Abteilung für Transplantationschirurgie; 🇦🇹 Graz, Austria