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

NCT ID: NCT00274625

Last Updated: 2014-11-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2012-09-30

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Surgisis Gold Graft

Group Type EXPERIMENTAL

Surgisis Gold Graft

Intervention Type DEVICE

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

2

Control

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

Incision is closed without the placement of a graft material (standard of care control)

Interventions

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Surgisis Gold Graft

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

Intervention Type DEVICE

Control

Incision is closed without the placement of a graft material (standard of care control)

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Biotech Incorporated

INDUSTRY

Sponsor Role collaborator

MED Institute, Incorporated

INDUSTRY

Sponsor Role collaborator

Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Sarr, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic Foundation

Locations

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Mayo Clinic Foundation

Rochester, Minnesota, United States

Site Status

St. Mary's Medical

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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: 10.1016/j.surg.2014.06.022.

Reference Type RESULT
PMID: 25239343 (View on PubMed)

Other Identifiers

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04-007

Identifier Type: -

Identifier Source: secondary_id

1076-05-00

Identifier Type: -

Identifier Source: org_study_id