Ventral Hernia Prevention After Liver Transplantation | NCT03222102

Studies
Ventral Hernia Prevention After Liver Transplantation

NCT03222102

Sponsor

Medical University of Graz

Status

Terminated

Last Update Posted

Jan 27, 2025Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Ventral Hernia
Liver Transplantation

Interventions

Phasix mesh

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to the changed standard regarding access for liver transplantation, this no longer complied with the requirements of the study protocol.

Expanded Access Info

Start Date

Nov 30, 2017Actual

Primary Completion Date

Nov 4, 2023Actual

Completion Date

Nov 4, 2023Actual

First Submitted Date

Jul 17, 2017

First Submission Date that Met QC Criteria

Jul 17, 2017

First Posted Date

Jul 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2025

Last Update Posted Date

Jan 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Phasix mesh	Device	After the closure of the Abdomen, Phasix mesh will be placed and affixed on the exposed fascia.	Phasix mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of ventral hernia	Evaluated by ultra-sound imaging	12 months after liver transplantation

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz; Klin. Abteilung für Transplantationschirurgie		Graz		8036	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006555	Hernia, Ventral

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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