Ventral Hernia Prevention After Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

Ventral Hernia Prevention After Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03222102
• Other study ID #: Ventral hernia prevention
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2023
• Source: Medical University of Graz
• Contact: Daniela Kniepeiss, MD
• Phone: 0043 316 385 13893
• Email: daniela.kniepeiss[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Liver Transplantation
• Ventral Hernia

Intervention

Device:
• Phasix mesh
After the closure of the Abdomen, Phasix mesh will be placed and affixed on the exposed fascia.

Locations

Country	Name	City	State
Austria	Medical University of Graz; Klin. Abteilung für Transplantationschirurgie	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ventral hernia	Evaluated by ultra-sound imaging	12 months after liver transplantation
Secondary	Infections	Number of infections in the wound area, assessed by clinical evaluation	12 months after liver transplantation
Secondary	Wound healing disorders	Presence of wound healing disorders in the wound area, assessed by clinical evaluation	12 months after liver transplantation
Secondary	Seroma	Presence of seroma in the wound area, assessed by clinical evaluation	12 months after liver transplantation
Secondary	Hematoma	Number of hematoma in the wound area, assessed by clinical evaluation	12 months after liver transplantation