Evaluation of Biodesign(R) Graft for Incision Reinforcement After Open Bariatric Surgery
This study has been completed.
Sponsor:
Cook
Collaborators:
Cook Biotech Incorporated
MED Institute, Incorporated
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00274625
First received: January 9, 2006
Last updated: January 4, 2013
Last verified: January 2013
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Purpose
The primary objective is to compare the effectiveness of the Biodesign Graft to suture closure alone in preventing an incisional hernia after open bariatric surgery.
| Condition | Intervention |
|---|---|
|
Hernia Obesity |
Device: Biodesign Graft Procedure: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Cook:
Primary Outcome Measures:
- Incidence of incisional hernias [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of wound infection, wound dehiscence, wound sinus tract [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 406 |
| Study Start Date: | August 2005 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Biodesign Graft
|
Device: Biodesign Graft
Biodesign Graft is placed as an underlay following open bariatric surgery.
|
|
Active Comparator: 2
Control
|
Procedure: Control
Incision is closed without the placement of a graft material (standard of care control)
|
Detailed Description:
This will be a prospective, randomized clinical trial comparing outcomes of use of a sublay of Biodesign 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 Biodesign 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274625
Locations
| United States, Florida | |
| University of South Florida Department of Surgery, Tampa General Hospital | |
| Tampa, Florida, United States, 33601 | |
| United States, Minnesota | |
| Mayo Clinic Foundation | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Virginia | |
| St. Mary's Medical | |
| Richmond, Virginia, United States, 23226 | |
Sponsors and Collaborators
Cook
Cook Biotech Incorporated
MED Institute, Incorporated
Investigators
| Principal Investigator: | Michael Sarr, MD | Mayo Clinic Foundation |
More Information
No publications provided
| Responsible Party: | Cook |
| ClinicalTrials.gov Identifier: | NCT00274625 History of Changes |
| Other Study ID Numbers: | 1076-05-00, 04-007 |
| Study First Received: | January 9, 2006 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cook:
|
Biomaterials Bariatric Surgery Hernia, Prevention of Obesity |
Bypass Surgery Incisional Hernia Ventral Hernia |
Additional relevant MeSH terms:
|
Hernia Obesity Pathological Conditions, Anatomical Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013