Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture closure alone in preventing an incisional hernia after open bariatric surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Incisional Hernia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]An obvious defect or interruption of the fascia in the area of the incision that was palpable on clinical examination and/or visible by a cross-sectional imaging modality.
|Study Start Date:||August 2005|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Surgisis Gold Graft
Device: Surgisis Gold Graft
Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
Active Comparator: 2
Incision is closed without the placement of a graft material (standard of care control)
This will be a prospective, randomized clinical trial comparing outcomes of use of a sublay of Surgisis Gold Graft for tissue reinforcement, as compared to suture closure alone in evaluating incidence of incisional hernias. Prior to undergoing open bariatric surgery, patients will be randomized to receive either Surgisis Gold Graft or suture closure alone. Subjects will be seen for follow-up visits at six weeks, three months, six months, one year and two years post-operatively. Patients may see their primary care physician for the one and two follow-up visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274625
|United States, Minnesota|
|Mayo Clinic Foundation|
|Rochester, Minnesota, United States, 55905|
|United States, Virginia|
|St. Mary's Medical|
|Richmond, Virginia, United States, 23226|
|Principal Investigator:||Michael Sarr, MD||Mayo Clinic Foundation|