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

Cook Group

Status

Completed

Conditions

Hernia

Obesity

Treatments

Procedure: Control

Device: Surgisis Gold Graft

Study type

Interventional

Funder types

Industry

Identifiers

NCT00274625

1076-05-00

04-007

Details and patient eligibility

About

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.

Full 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.

Enrollment

402 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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