Status:
COMPLETED
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
Lead Sponsor:
Cook Group Incorporated
Collaborating Sponsors:
Cook Biotech Incorporated
MED Institute, Incorporated
Conditions:
Hernia
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Planned operative approach via upper midline incision with goal of weight loss
- 18 years of age or older
- Body mass index (BMI) \>= 30 kg/m2
- Documented history of non-surgical attempts at weight loss
- Patients undergoing reoperation for a failed previous bariatric procedure are eligible provided the operation is being performed for weight loss and provided at the time of reoperation there is no incisional hernia
- Patients with small, non-incarcerated, previously unrepaired umbilical hernias are acceptable provided the hernia defect is no greater than 2.5 cm in diameter
Exclusion
- Patients with pre-existing midline abdominal wall incisional hernia or diastasis rectus
- Patients undergoing repeat bariatric surgery for complications of a previous bariatric procedure
- Patients with a previous upper midline incision found to have an incisional hernia
- Patients with connective tissue disorders known to predispose to hernia formation
- Active infection at the time of proposed surgery
- Sensitivity or religious objections to porcine products
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00274625
Start Date
August 1 2005
End Date
September 1 2012
Last Update
November 12 2014
Active Locations (2)
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1
Mayo Clinic Foundation
Rochester, Minnesota, United States, 55905
2
St. Mary's Medical
Richmond, Virginia, United States, 23226