Evaluation of Biodesign(R) Graft for Incision Reinforcement After Open Bariatric Surgery

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014