Mesh Type in Ventral Hernia Repair

NCT03091790 | Completed DMC

• 1 other identifier: HSC-MS-16-0936
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Keywords

ventral hernia; mesh

Outcome Measures

Primary Outcomes (1)

• Complication free at 1 year post-operative

  Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation

  1 year after surgery

Secondary Outcomes (4)

• Complication free at 3 years post-operative

  3 years after surgery

• Dindo-clavien complications

  Pre-operative, 1 month after surgery, 1 year and 3 years after surgery

• Patient centered outcomes

  Pre-operative, 1 month after surgery, 1 year and 3 years after surgery

• Cost

  1 year and 3 years after surgery

Study Arms (2)

Synthetic Mesh

ACTIVE COMPARATOR

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

Device: Synthetic Mesh

Biologic Mesh

ACTIVE COMPARATOR

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

Device: Biologic Mesh

Interventions

Synthetic Mesh DEVICE

Synthetic mesh used during open ventral hernia repair

Synthetic Mesh

Biologic Mesh DEVICE

Biologic mesh used during open ventral hernia repair

Biologic Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

UT Health at Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie L Holihan, M.D.

  UT Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: March 27, 2017
• Primary Completion: July 26, 2020
• Study Completion: July 31, 2021
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (1)