Expired Study
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Cleveland, Ohio 44195


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 (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.


Study summary:

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


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


Study is Available At:


Original ID:

IRB 14-1571


NCT ID:

NCT02451176


Secondary ID:


Study Acronym:

ventral hernia


Brief Title:

Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias


Official Title:

A Prospective Randomized Trial of Biologic Mesh Versus Synthetic Mesh for the Repair of Complex Ventral Hernias


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Cleveland Clinic


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

253


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael Rosen, MD
Principal Investigator
Cleveland Clinic, Cleveland, Ohio, United States, 44195

Study Dates

Start Date:April 2015
Completion Date:December 31, 2021
Completion Type:Anticipated
Primary Completion Date:December 31, 2019
Primary Completion Type:Anticipated
Verification Date:April 2019
Last Changed Date:April 12, 2019
First Received Date:May 19, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:absence of surgical site occurence requiring procedural intervention and fewer recurrent hernias
Time Frame:2 years from surgery
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The direct and indirect costs associated with the use of either polypropylene or biologic mesh
Time Frame:up to 2 years after surgery
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Device
Name:Davol Bard Soft Mesh synthetic
Description:soft mesh synthetic
Arm Name:Active Comparator: Davol Bard ®Soft Mesh
Intervention Type:Device
Name:LifeCell Strattice Reconstructive Tissue Biologic
Description:biologic mesh
Arm Name:Active Comparator: LifeCell Strattice®

Study Arms

Study Arm Type:Active Comparator
Arm Name:Active Comparator: LifeCell Strattice®
Description: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
Study Arm Type:Active Comparator
Arm Name:Active Comparator: Davol Bard ®Soft Mesh
Description: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)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Michael Rosen

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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