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

NCT00274625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2014-11-12

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Cook Biotech Incorporated

    collaborator INDUSTRY

  • MED Institute, Incorporated

    collaborator INDUSTRY

  • Cook Group Incorporated

    lead INDUSTRY

Principal Investigators

  • Michael Sarr, MD · Mayo Clinic Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00274625 on ClinicalTrials.gov