Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 8, 2014
Last verified: May 2014
  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 clean-contaminated (Class2) 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.


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: Double Blind (Subject, Outcomes Assessor)
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 be absence of surgical site occurence requiring procedural intervention 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 clean-contaminated or contaminated ventral hernia repair using either polypropylene mesh or biologic mesh from a limited societal perspective.

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

    Calculate and compare incremental cost effectiveness ratios for patients undergoing repair of clean-contaminated or contaminated ventral hernias using either polypropylene mesh 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: 253
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 clean-contaminated or 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 clean-contaminated or contaminated abdominal wall hernias
Other Name: Biologic mesh Strattice™

Detailed Description:

This is a multicenter prospective double-blinded randomized controlled trial comparing 253 patients with clean-contaminated (Class 2)or contaminated (Class3) 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 stage open reconstruction of clean-contaminated and contaminated abdominal wall defects. The primary outcome variable will be the absence of surgical site occurence requiring procedural intervention and the absence of a hernia recurrence from the time of surgery up to 24 months of postoperative follow up.

Patients undergoing open ventral hernia repair for clean-contamination and contaminated abdominal wall hernias meeting inclusion criteria will be randomized to receive a synthetic mesh or a biologic mesh. Randomization will be carried out using computer-generated randomization blocks at the time of enrollment. Stratified randomized will be used with the strata formulated by medical center then by clean-contaminated or contaminated surgical site class. The Investigator will be blinded to patient randomization assignment until the point of intra-operative device use following final CDC wound classification, whereas patients and co-investigators responsible for data analysis will remain blinded to patient randomization until the conclusion of the study period. As such, a double-blinded study protocol will be maintained. 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, presence or absence of surgical site occurrences (SSOs) and any procedural interventions required to treat these SSOs, presence or absence of hernia recurrence and any reoperations, length of hospital stay, discharge date, time to return of bowel function and any readmission.

Active participation in this study will last for 24 months and will involve one preoperative evaluation visit, one operative procedure visit, and 4 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 macroporous light-weight polypropylene mesh is more cost effective strategy than a biologic prosthetic in clean-contaminated and 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:

  1. The subject is > 21 years of age (including women of childbearing age)
  2. Scheduled to undergo a planned open single stage reconstruction of a contaminated (CDC wound class2 or 3) abdominal wall defect
  3. Ability to undergo general anesthesia
  4. Is willing and able to give informed consent
  5. Is this a clean-contaminated (Class 2) or contaminated (Class 3) case per CDC Guidelines?
  6. 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.
  7. Can achieve midline fascial closure?
  8. Is subject willing to return for scheduled and required study visits?

Exclusion Criteria:

  1. Patients have a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh.
  2. Is the patients BMI over 45 kg/m2?
  3. Is the patient currently pregnant?
  4. Will undergo a laparoscopic or robotic hernia repair.
  5. Do they have a class 1 or 4 wound per CDC Guidelines?
  6. Are they on immunosuppression including medically-induced with>10 mg of prednisone/day?
  7. Do they have a collagen vascular disorder?
  8. 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)
  9. Does the patient have Ascites refractory to medical management?
  10. 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)?
  11. Is the patient severely malnourished as defined by serum albumin<2.0g/dl?
  12. Do they have a smoking history within 1 month of surgery?
  13. Does the patient have an objection to the implantation of porcine products?
  14. Is the subject participating in another clinical study?
  15. Are unable to undergo successful retro-rectus/preperitoneal mesh placement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Missouri
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Jaime Cavallo, MD    314-747-1287    cavalloj@wudosis.wustl.edu   
Principal Investigator: Jaime A Cavallo, MD.         
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         
Sub-Investigator: Yuri W. Novitsky, MD,FACS         
Sub-Investigator: Ajita S Prabhu, MD.         
United States, South Carolina
Greenville Hospital System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Elizabeth F. O'steen    864-676-1072    EOsteen@ghs.org   
Principal Investigator: Alfredo M. Carbonell, DO.,FACS         
Sub-Investigator: William S Cobb, MD,FACS         
Sub-Investigator: Christine P Koop, PM-C         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-2577
Contact: Joan Kaiser, RN    615-343-5821    joan.l.kaiser@vanderbilt.edu   
Principal Investigator: Benjamin K Poulose, MD         
Sub-Investigator: Michael Holzman, MD.,MPH         
Sub-Investigator: Kyla P. Terhune, MD.         
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: May 8, 2014
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 July 22, 2014