Mesh Type in Ventral Hernia Repair

Not Applicable

Completed

• Conditions: Ventral Hernia
• Interventions: Device: Synthetic Mesh; Device: Biologic Mesh

• Registration Number: NCT03091790
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-21
• Study Start: 2017-03-27
• Study First Posted: 2017-03-27
• Primary Completion: 2020-07-26
• Study Completion: 2021-07-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synthetic Mesh	Synthetic Mesh	Synthetic mesh (mid-density polypropylene (generic) Bard soft mesh) will be used in open ventral hernia repair
Biologic Mesh	Biologic Mesh	Biologic mesh (non cross linked porcine acellular dermal matrix: Strattice) will be used in open ventral hernia repair

Primary Outcome Measures

Name	Time	Method
Complication free at 1 year post-operative	1 year after surgery	Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UT Health at Lyndon B. Johnson General Hospital; 🇺🇸 Houston, Texas, United States