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Ventral Hernia Prevention After Liver Transplantation

Primary Purpose

Ventral Hernia, Liver Transplantation

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Phasix mesh
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventral Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Graz; Klin. Abteilung für TransplantationschirurgieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Phasix mesh

Standard surgery

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of ventral hernia
Evaluated by ultra-sound imaging

Secondary Outcome Measures

Infections
Number of infections in the wound area, assessed by clinical evaluation
Wound healing disorders
Presence of wound healing disorders in the wound area, assessed by clinical evaluation
Seroma
Presence of seroma in the wound area, assessed by clinical evaluation
Hematoma
Number of hematoma in the wound area, assessed by clinical evaluation

Full Information

First Posted
July 17, 2017
Last Updated
May 4, 2023
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT03222102
Brief Title
Ventral Hernia Prevention After Liver Transplantation
Official Title
Ventral Hernia Prevention After Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia, Liver Transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phasix mesh
Arm Type
Experimental
Arm Description
Phasix mesh will be affixed to the exposed fascia after closure of the Abdomen in the course of liver transplantation.
Arm Title
Standard surgery
Arm Type
No Intervention
Arm Description
Surgery will be performed according to routine, without the use of Phasix mesh.
Intervention Type
Device
Intervention Name(s)
Phasix mesh
Intervention Description
After the closure of the Abdomen, Phasix mesh will be placed and affixed on the exposed fascia.
Primary Outcome Measure Information:
Title
Incidence of ventral hernia
Description
Evaluated by ultra-sound imaging
Time Frame
12 months after liver transplantation
Secondary Outcome Measure Information:
Title
Infections
Description
Number of infections in the wound area, assessed by clinical evaluation
Time Frame
12 months after liver transplantation
Title
Wound healing disorders
Description
Presence of wound healing disorders in the wound area, assessed by clinical evaluation
Time Frame
12 months after liver transplantation
Title
Seroma
Description
Presence of seroma in the wound area, assessed by clinical evaluation
Time Frame
12 months after liver transplantation
Title
Hematoma
Description
Number of hematoma in the wound area, assessed by clinical evaluation
Time Frame
12 months after liver transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Kniepeiss, MD
Phone
0043 316 385 13893
Email
daniela.kniepeiss@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Auer, MD, Professor
Email
thomas.auer@medunigraz.at
Facility Information:
Facility Name
Medical University of Graz; Klin. Abteilung für Transplantationschirurgie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Kniepeiss, MD
Phone
0043 316 385 13893
Email
daniela.kniepeiss@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Thomas Auer, Prof.
Phone
0043 316-385-81183
Email
thomas.auer@medunigraz.at

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ventral Hernia Prevention After Liver Transplantation

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