Mesh Type in Ventral Hernia Repair

The University of Texas System (UT)

Status: Completed

Conditions: Ventral Hernia

Treatments: Device: Synthetic Mesh; Device: Biologic Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03091790

HSC-MS-16-0936

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 2 patient groups

Synthetic Mesh

Active Comparator group

Description:

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

Treatment:

Device: Synthetic Mesh

Biologic Mesh

Active Comparator group

Description:

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

Treatment:

Device: Biologic Mesh