Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Surgisis Gold 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: November 10, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Hernia
Obesity
Device: Surgisis Gold 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:
  • 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.


Enrollment: 402
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
Surgisis Gold Graft
Device: Surgisis Gold Graft
Surgisis Gold 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 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.

  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, 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

Publications:
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
Results First Received: October 24, 2014
Last Updated: November 10, 2014
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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014