Mesh Type in Ventral Hernia Repair

June 20, 2023 updated by: Julie Holihan, The University of Texas Health Science Center, Houston
Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77026
        • UT Health at Lyndon B. Johnson General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient scheduled for open ventral hernia repair at LBJ General Hospital

Exclusion Criteria:

  • Active infection
  • Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis)
  • Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown)
  • Patient unlikely to follow-up (i.e. no phone)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Synthetic Mesh
Synthetic mesh (mid-density polypropylene (generic) Bard soft mesh) will be used in open ventral hernia repair
Device: Synthetic Mesh
Synthetic mesh used during open ventral hernia repair
Active Comparator: Biologic Mesh
Biologic mesh (non cross linked porcine acellular dermal matrix: Strattice) will be used in open ventral hernia repair
Device: Biologic Mesh
Biologic mesh used during open ventral hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication free at 1 year post-operative
Time Frame: 1 year after surgery
Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication free at 3 years post-operative
Time Frame: 3 years after surgery
Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
3 years after surgery
Dindo-clavien complications
Time Frame: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
Grade I to V
Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
Patient centered outcomes
Time Frame: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
includes patient satisfaction, cosmetic satisfaction, modified assessment scale
Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
Cost
Time Frame: 1 year and 3 years after surgery
charges for all patient visits, admissions, and procedures
1 year and 3 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Julie L Holihan, M.D., UT Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2017

Primary Completion (Actual)

July 26, 2020

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-16-0936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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