Mesh Type in Ventral Hernia Repair

NCT ID: NCT03091790

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-27

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Synthetic Mesh

Synthetic mesh (mid-density polypropylene (generic) Bard soft mesh) will be used in open ventral hernia repair

Group Type ACTIVE_COMPARATOR

Synthetic Mesh

Intervention Type DEVICE

Synthetic mesh used during open ventral hernia repair

Biologic Mesh

Biologic mesh (non cross linked porcine acellular dermal matrix: Strattice) will be used in open ventral hernia repair

Group Type ACTIVE_COMPARATOR

Biologic Mesh

Intervention Type DEVICE

Biologic mesh used during open ventral hernia repair

Interventions

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Synthetic Mesh

Synthetic mesh used during open ventral hernia repair

Intervention Type DEVICE

Biologic Mesh

Biologic mesh used during open ventral hernia repair

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Julie Holihan

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie L Holihan, M.D.

Role: PRINCIPAL_INVESTIGATOR

UT Health

Locations

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UT Health at Lyndon B. Johnson General Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-16-0936

Identifier Type: -

Identifier Source: org_study_id

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