Liver Transplantation, Ventral Hernia
Conditions
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.
Interventions
DEVICEPhasix mesh
After the closure of the Abdomen, Phasix mesh will be placed and affixed on the exposed fascia.
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ventral hernia | 12 months after liver transplantation | Evaluated by ultra-sound imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infections | 12 months after liver transplantation | Number of infections 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 |
| Hematoma | 12 months after liver transplantation | Number of hematoma in the wound area, assessed by clinical evaluation |
Countries
Austria
Outcome results
None listed