Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274625
• Other study ID #: 1076-05-00
• Secondary ID: 04-007
• Status: Completed
• Phase: N/A
• First received: January 9, 2006
• Last updated: November 10, 2014
• Start date: August 2005
• Est. completion date: September 2012

Study information

• Verified date: November 2014
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Obesity

Intervention

Device:
• Surgisis Gold Graft
Surgisis Gold Graft is placed as an underlay following open bariatric surgery.

Procedure:
• Control
Incision is closed without the placement of a graft material (standard of care control)

Locations

Country	Name	City	State
United States	St. Mary's Medical	Richmond	Virginia
United States	Mayo Clinic Foundation	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Cook	Cook Biotech Incorporated, MED Institute, Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	Yes