NCT03222102

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2023

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

5.9 years

First QC Date

July 17, 2017

Last Update Submit

January 23, 2025

Conditions

Ventral HerniaLiver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Incidence of ventral hernia

    Evaluated by ultra-sound imaging

    12 months after liver transplantation

Secondary Outcomes (4)

  • Infections

    12 months after liver transplantation

  • Wound healing disorders

    12 months after liver transplantation

  • Seroma

    12 months after liver transplantation

  • Hematoma

    12 months after liver transplantation

Study Arms (2)

Phasix mesh

EXPERIMENTAL

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

Device: Phasix mesh

Standard surgery

NO INTERVENTION

Surgery will be performed according to routine, without the use of Phasix mesh.

Interventions

Phasix meshDEVICE

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

Phasix mesh

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz; Klin. Abteilung für Transplantationschirurgie

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 19, 2017

Study Start

November 30, 2017

Primary Completion

November 4, 2023

Study Completion

November 4, 2023

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)