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

Study Overview
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Brief Summary
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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
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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
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Hernia, Obesity

Intervention / Treatment
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* Device: Surgisis Gold Graft
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Surgisis Gold Graft | Device: Surgisis Gold Graft<br>* Surgisis Gold Graft is placed as an underlay following open bariatric surgery.<br>|
| Active Comparator: 2<br>Control | Procedure: Control<br>* Incision is closed without the placement of a graft material (standard of care control)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomaterials, Bariatric Surgery, Hernia, Prevention of, Obesity, Bypass Surgery, Incisional Hernia, Ventral Hernia