Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias (ventral hernia)
|ClinicalTrials.gov Identifier: NCT02451176|
Recruitment Status : Enrolling by invitation
First Posted : May 21, 2015
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ventral Hernia||Device: Davol Bard Soft Mesh synthetic Device: LifeCell Strattice Reconstructive Tissue Biologic||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective Randomized Trial of Biologic Mesh Versus Synthetic Mesh for the Repair of Complex Ventral Hernias|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Active Comparator: Davol Bard ®Soft Mesh
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
soft mesh synthetic
Active Comparator: Active Comparator: LifeCell 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
Device: LifeCell Strattice Reconstructive Tissue Biologic
- absence of surgical site occurence requiring procedural intervention and fewer recurrent hernias [ Time Frame: 2 years from surgery ]
- The direct and indirect costs associated with the use of either polypropylene or biologic mesh [ Time Frame: up to 2 years after surgery ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451176
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Michael Rosen, MD||Cleveland Clinic, Cleveland, Ohio, United States, 44195|