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

Completed · Not applicable

Conditions studied: Hernia, Obesity

In brief

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.

Key facts

Study ID

NCT00274625

Run by

Cook Group Incorporated

People needed

402

Starts

2005-08-01

Expected to finish

2012-09-01

Last updated by the study team

2014-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Foundation — Rochester, Minnesota, United States
• St. Mary's Medical — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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