Ventral Hernia Prevention After Liver Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ventral Hernia Prevention After Liver Transplantation

Conditions
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Ventral Hernia, Liver Transplantation

Intervention / Treatment
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* Device: Phasix mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |