Ventral Hernia Prevention After Liver Transplantation

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Transplantation; Ventral Hernia
• Intervention / Treatment: Device: Phasix mesh

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 Type: Interventional
• Enrollment (Anticipated): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela Kniepeiss, MD; Phone Number: 0043 316 385 13893; Email: daniela.kniepeiss@medunigraz.at
• Study Contact Backup: Name: Thomas Auer, MD, Professor; Email: thomas.auer@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medical University of Graz; Klin. Abteilung für Transplantationschirurgie
    • Contact: Daniela Kniepeiss, MD; Phone Number: 0043 316 385 13893; Email: daniela.kniepeiss@medunigraz.at
    • Contact: Thomas Auer, Prof.; Phone Number: 0043 316-385-81183; Email: thomas.auer@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phasix mesh; Phasix mesh will be affixed to the exposed fascia after closure of the Abdomen in the course of liver transplantation.	Device: Phasix mesh; After the closure of the Abdomen, Phasix mesh will be placed and affixed on the exposed fascia.
No Intervention: Standard surgery; Surgery will be performed according to routine, without the use of Phasix mesh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ventral hernia	Evaluated by ultra-sound imaging	12 months after liver transplantation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: Ventral hernia prevention

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No