NCT00274625

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hernia
• Obesity

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2005-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2006-01-11
• Last updated: 2014-11-12
• Results posted: 2014-11-12

Locations

2 sites across 1 country: United States