Back to resultsEvaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
Primary Purpose
Hernia, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgisis Gold Graft
Control
Sponsored by
About this trial
This is an interventional treatment trial for Hernia focused on measuring Biomaterials, Bariatric Surgery, Hernia, Prevention of, Obesity, Bypass Surgery, Incisional Hernia, Ventral Hernia
Eligibility 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
Sites / Locations
- Mayo Clinic Foundation
- St. Mary's Medical
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Surgisis Gold Graft
Control
Outcomes
Primary Outcome Measures
Incisional Hernia
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00274625
First Posted
January 9, 2006
Last Updated
November 10, 2014
Sponsor
Cook Group Incorporated
Collaborators
Cook Biotech Incorporated, MED Institute, Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00274625
Brief Title
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
Collaborators
Cook Biotech Incorporated, MED Institute, Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Obesity
Keywords
Biomaterials, Bariatric Surgery, Hernia, Prevention of, Obesity, Bypass Surgery, Incisional Hernia, Ventral Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Surgisis Gold Graft
Arm Title
2
Arm Type
Active Comparator
Arm Description
Control
Intervention Type
Device
Intervention Name(s)
Surgisis Gold Graft
Intervention Description
Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Incision is closed without the placement of a graft material (standard of care control)
Primary Outcome Measure Information:
Title
Incisional Hernia
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Sarr, MD
Organizational Affiliation
Mayo Clinic Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Foundation
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Mary's Medical
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25239343
Citation
Sarr MG, Hutcher NE, Snyder S, Hodde J, Carmody B. A prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery. Surgery. 2014 Oct;156(4):902-8. doi: 10.1016/j.surg.2014.06.022.
Results Reference
result
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Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
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