Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias

NCT02451176 | Completed Results DMC

• 1 other identifier: IRB 14-1571
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 4

Brief Summary

This study will compare the safety, efficacy and cost effectiveness of a permanent synthetic mesh versus a biologic prosthesis for the repair of ventral hernias in the setting of clean-contaminated (Class 2) or contaminated (Class 3) surgical procedures. The findings of this study will have a major impact on the field of hernia surgery as it will provide objective guide to mesh selection, optimize surgical approaches for complex ventral hernia repair, and ultimately significantly improve patient outcomes.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Absence of Surgical Site Occurrence Requiring Procedural Intervention

  2 years from surgery

• Total Number of Participants With Recurrence of Hernias

  2 years post surgery

Secondary Outcomes (1)

• Direct Costs Associated With the Use of Either Polypropylene or Biologic Mesh

  30 days post surgery

Study Arms (2)

Active Comparator: Davol Bard ®Soft Mesh

ACTIVE COMPARATOR

Device: Davol Bard ®Soft Mesh Synthetic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: synthetic mesh SoftMesh™ (CR Bard)

Device: Davol Bard Soft Mesh synthetic

Active Comparator: LifeCell Strattice®

ACTIVE COMPARATOR

Device: LifeCell Strattice® Reconstructive Tissue Matrix Biologic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: Biologic mesh Strattice

Device: LifeCell Strattice Reconstructive Tissue Biologic

Interventions

Davol Bard Soft Mesh synthetic DEVICE

soft mesh synthetic

Active Comparator: Davol Bard ®Soft Mesh

LifeCell Strattice Reconstructive Tissue Biologic DEVICE

biologic mesh

Active Comparator: LifeCell Strattice®

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is \> 21 years of age (including women of childbearing age)
• Scheduled to undergo a planned open single stage reconstruction of a contaminated (CDC wound class2 or 3) abdominal wall defect
• Ability to undergo general anesthesia
• Is willing and able to give informed consent
• Is this a clean-contaminated (Class 2) or contaminated (Class 3) case per CDC Guidelines?
• Has an estimated parastomal hernia or midline defect size of \>9 cm 2 contaminated (CDC wound class 2 or 3) abdominal wall defect by physical /or radiological exam.
• Can achieve midline fascial closure?
• Is subject willing to return for scheduled and required study visits? -

You may not qualify if:

• Patients have a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh.
• Is the patients BMI over 45 kg/m2?
• Is the patient currently pregnant?
• Will undergo a laparoscopic or robotic hernia repair.
• Do they have a class 1 or 4 wound per CDC Guidelines?
• Are they on immunosuppression including medically-induced with\>10 mg of prednisone/day?
• Do they have a collagen vascular disorder?
• Is patient having a prior mesh removed due to a current active mesh infection? (A synthetic mesh that is not incorporated into the tissue, is extracorporeally exposed or has a chronic draining sinus with clear fluid around the material, but not including synthetic mesh incorporated in abdominal wall and not infected)
• Does the patient have Ascites refractory to medical management?
• Are they in end stage renal (on hemodialysis or peritoneal dialysis) or pre-existing liver disease (Hepatitis B or C or Total Bilirubin \>3.0mg/dl)?
• Is the patient severely malnourished as defined by serum albumin\<2.0g/dl?
• Do they have a smoking history within 1 month of surgery?
• Does the patient have an objection to the implantation of porcine products?
• Is the subject participating in another clinical study?
• Are unable to undergo successful retro-rectus/preperitoneal mesh placement

Sponsors & Collaborators

• Michael Rosen: lead

Study Sites (4)

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of South Carolina School of Medicine

Greenville, South Carolina, 29605, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• Miller BT, Krpata DM, Petro CC, Beffa LRA, Carbonell AM, Warren JA, Poulose BK, Tu C, Prabhu AS, Rosen MJ. Biologic vs Synthetic Mesh for Parastomal Hernia Repair: Post Hoc Analysis of a Multicenter Randomized Controlled Trial. J Am Coll Surg. 2022 Sep 1;235(3):401-409. doi: 10.1097/XCS.0000000000000275. Epub 2022 Aug 10.

  PMID: 35588504 DERIVED

• Rosen MJ, Krpata DM, Petro CC, Carbonell A, Warren J, Poulose BK, Costanzo A, Tu C, Blatnik J, Prabhu AS. Biologic vs Synthetic Mesh for Single-stage Repair of Contaminated Ventral Hernias: A Randomized Clinical Trial. JAMA Surg. 2022 Apr 1;157(4):293-301. doi: 10.1001/jamasurg.2021.6902.

  PMID: 35044431 DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Michael Rosen
• Organization: Cleveland Clinic Foundation

rosenm@ccf.org

12164453441

Study Officials

• Michael Rosen, MD

  Cleveland Clinic, Cleveland, Ohio, United States, 44195

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Michael Rosen, MD

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: September 7, 2022
• Results First Posted: September 7, 2022

Record last verified: 2022-08

Locations

US (4)