Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias

This study is currently recruiting participants.
Verified December 2012 by University Hospitals of Cleveland
Sponsor:
Collaborator:
American Hernia Society
Information provided by (Responsible Party):
Michael J. Rosen, MD., University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01746316
First received: November 15, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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 contamination.

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 and ultimately maximize patient outcomes.


Condition Intervention
Ventral Hernia
Device: Davol Bard ®Soft Mesh
Device: LifeCell Strattice® Reconstructive Tissue Matrix

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Biologic Mesh Versus Synthetic Mesh for the Repair of Complex Ventral Hernias.

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • The number of participants with healed wounds and fewer recurrent hernias [ Time Frame: 2 years from surgery ] [ Designated as safety issue: Yes ]
    Show that a contaminated ventral hernia repair performed with polypropylene mesh will result in healed wounds with fewer recurrent hernias than repairs using a biologic mesh by the 2 year follow up.


Secondary Outcome Measures:
  • The direct and indirect costs associated with the use of either polypropylene or biologic mesh. [ Time Frame: up to 2 years after surgery ] [ Designated as safety issue: No ]

    Estimate direct and indirect economic costs associated with contaminated ventral hernia repair using polypropylene or biologic mesh from a limited societal perspective.

    Perform health utility valuation in patients undergoing repair of contaminated ventral hernias using either polypropylene or biologic mesh.

    Calculate and compare incremental cost effectiveness ratios for patients undergoing repair of contaminated ventral hernias using either polypropylene or biologic mesh.



Other Outcome Measures:
  • Measure pain and quality of life (QOL). [ Time Frame: From the preoperative screening visit up until 2 years after surgery ] [ Designated as safety issue: No ]
    Patients will also fill out pain and quality of life tools during the preoperative visit and at follow up visits


Estimated Enrollment: 70
Study Start Date: September 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Davol Bard ®Soft Mesh
synthetic mesh SoftMesh™ (CR Bard)
Device: Davol Bard ®Soft Mesh
Synthetic mesh for open ventral hernia repair for contaminated abdominal wall hernias
Other Name: synthetic mesh SoftMesh™ (CR Bard)
Active Comparator: LifeCell Strattice® Reconstructive Tissue Matrix
Biologic mesh Strattice™
Device: LifeCell Strattice® Reconstructive Tissue Matrix
Biologic mesh for open ventral hernia repair for contaminated abdominal wall hernias
Other Name: Biologic mesh Strattice™

Detailed Description:

This is a prospective single blinded randomized controlled trial comparing patients with contaminated abdominal wall ventral hernias undergoing single staged repair. Soft Mesh by CR Bard, a macroporous monofilament polypropylene permanent mesh will be compared to Strattice mesh by Lifecell, a non-cross linked porcine dermal biologic graft for the single staged reconstruction of contaminated abdominal wall defects. The primary outcome variable will be if the wound is healed along with the absence of a hernia recurrence from the time of surgery up to the 2 year follow up.

Patients undergoing open ventral hernia repair for contaminated abdominal wall hernias meeting inclusion criteria will be randomized to receive a synthetic mesh or a biologic mesh. Patients randomized to synthetic mesh will receive SoftMesh™ (CR Bard, Murray Hill, NJ) and those patients randomized to biologic mesh will receive Strattice™ (Lifecell, Branchburg NJ). The use of biologic and synthetic mesh in contaminated fields is considered experimental however the selection of these prosthetics was based on a careful review of the multiple animal models, preclinical data, and our own clinical experience with each of these materials placed in both clean and contaminated abdominal wall reconstructions. Surgical wounds will be classified based on CDC(Centers for Disease Control)criteria and only Class 2 and 3 wounds will be included in this study.

Postoperatively patients will be evaluated for signs and symptoms of complications along with presence or absence of Surgical Site Infections per CDC guidelines, time to return of bowel function, length of stay, and readmission rates.

Active participation in this study will last for 24 months and will involve one preoperative evaluation visit, one operative procedure visit, and 5 follow up visits. Participants will complete two brief survey questionnaires regarding quality of life, activities and pain.

The second outcome will be to demonstrate that a permanent prosthetic mesh is the more cost effective strategy than a biologic prosthetic in contaminated abdominal wall reconstruction.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subject is > 21 years of age
  • Scheduled to undergo a planned open single staged reconstruction of a contaminated abdominal wall defect
  • Ability to undergo general anesthesia
  • Is contamination known preoperatively?
  • Is willing and able to give informed consent
  • Is this a clean-contaminated or contaminated case per Surgical Site Infection Risk Guidelines?
  • Has an estimated hernia size of >9 cm 2 by physical /or radiological exam.
  • Can achieve midline fascial closure?
  • Is subject willing to return for scheduled and required study visits?

Exclusion Criteria:

  • Patients have a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh.
  • Is the patients BMI over 45?
  • Is the patient Pregnant?
  • Will undergo a laparoscopic hernia repair.
  • Do they have a class 1 or 4 wound per Surgical Site Infection Risk Guidelines?
  • Are they on immunosuppression>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 is exposed or has a chronic draining sinus with clear pus around the material. Does not include synthetic mesh incorporated in abdominal wall and not infected)
  • Does the patient have Ascites?
  • Are they in end stage renal (on hemodialysis) or pre-existing liver disease (Hepatitis C or Total Bilirubin >3.0)?
  • Is the patient malnourished as defined by serum albumin<2.0?
  • 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?
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746316

Contacts
Contact: Christina M Seafler, RN. CCRP 216-844-4706 christina.seafler@UHhospitals.org

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Christina M Seafler, RN. CCRP    216-844-4706    christina.seafler@UHhospitals.org   
Principal Investigator: Michael J Rosen, MD,FACS         
Sponsors and Collaborators
University Hospitals of Cleveland
American Hernia Society
Investigators
Principal Investigator: Michael J Rosen, MD. University Hospitals of Cleveland
  More Information

No publications provided

Responsible Party: Michael J. Rosen, MD., Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01746316     History of Changes
Other Study ID Numbers: 06-12-09
Study First Received: November 15, 2012
Last Updated: December 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University Hospitals of Cleveland:
Incisional hernia

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 22, 2014