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Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement (COBRA)

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ClinicalTrials.gov Identifier: NCT01325792
Recruitment Status : Completed
First Posted : March 30, 2011
Results First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Description
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Brief Summary:
Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair.

Condition or disease Intervention/treatment
Ventral Incisional Hernia Device: GORE® BIO-A® Tissue Reinforcement

Detailed Description:
The study will evaluate the performance of the biosynthetic mesh when used to reinforce the midline fascial closure in single-staged open complex ventral incisional hernia repair. It is designed to test the null hypothesis that the two year recurrence rate associated with the device is greater than or equal to 50% vs the alternative hypothesis that the two year recurrence rate is less than 50%.
Study Design
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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biosynthetic Material for Midline Fascial Closure Reinforcement
Study Start Date : February 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Groups and Cohorts
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Group/Cohort Intervention/treatment
GORE® BIO-A® Tissue Reinforcement
Single-staged open complex ventral incisional repair of primary or recurrent anterior abdominal wall hernia.
 Device: GORE® BIO-A® Tissue Reinforcement
Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.
Other Name: Biosynthetic Mesh


Outcome Measures
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Primary Outcome Measures :
  1. Hernia Recurrence Rate [ Time Frame: at about 24 months ]
    Investigator confirmed hernia recurrence by physical examination


Secondary Outcome Measures :
  1. Early and Long-term Complication Rates [ Time Frame: after surgery (day 1) to 24 months ]
    Surgical site abdominal wound event rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
general and teaching hospitals
Criteria

Inclusion Criteria:

  • Subjects will be informed about the study, and will have read; understood and signed the informed consent and authorization to use their PHI, as applicable
  • Subjects willing and able to submit to postoperative follow-up evaluations including quality of life assessments up to 24 months after surgery
  • Subjects of either gender that are at least the age of 18 years
  • Subjects will have a Body-Mass Index (BMI) of < 40
  • Subjects will be undergoing single-staged open complex ventral incisional hernia repair with the retrorectus or intraperitoneal placement technique of the GORE® BIO-A® Tissue Reinforcement
  • Subjects in which intraoperatively their surgical field/wound is characterized either a Type 2 or Type 3 in Table 1 in Section 12.0
  • Subjects with a hernia defect > 9 cm2 large when measured intraoperatively
  • Subjects in which the required mobility for midline fascial closure without excessive tension to reapproximate the rectus abdominis muscle intraoperatively can be achieved
  • Subjects in which one unit of GORE® BIO-A® Tissue Reinforcement will adequately reinforce the midline fascial closure with at least 4 cm of overlap laterally

Exclusion Criteria:

  • Subjects who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study
  • Subjects with a BMI > 40
  • Subjects with evidence of pre-existing systemic infections
  • Subjects with cirrhosis or are currently being treated with dialysis
  • Subjects with a wound-healing disorder
  • Subjects with autoimmune disorder requiring > 10mg of a corticosteroid per day
  • Subjects who are immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy
  • Subjects with a hernia defect < 9 cm2 large when measured intraoperatively
  • Subjects with a hernia defect requiring more than one unit of GORE® BIO-A® Tissue Reinforcement
  • Subjects in which intraoperatively there is an inability to achieve retrorectus or intraperitoneal placement of the device
  • Subjects in which a midline fascial closure without excessive tension cannot be achieved
  • Subjects in which intraoperatively their surgical field/wound is characterized either a Type 1 or Type 4 in the Table 1 in Section 12
  • Subjects in need of concomitant surgical procedures other than indicated in the protocol as acceptable
  • Subject in which their complex ventral incisional hernia repair requires more than one operation to reduce hernia and close fascia, including serial excision procedures - requiring subsequent surgery to complete their hernia repair
  • Subjects with a hernia repair requiring an emergent procedure, such as strangulated bowel
  • Subjects in which intraoperatively untreated cancer was found
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325792


Locations
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United States, California
UCSD Department of Surgery
San Diego, California, United States, 92103
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
Mount Sinai Medical Center
New York City, New York, United States, 10021
United States, Ohio
Case Medical Center, Case Western Reserve University, Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29607
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, The Netherlands, Netherlands
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Michael Rosen, MD University Hospitals Cleveland Medical Center
More Information
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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01325792    
Other Study ID Numbers: CS155
First Posted: March 30, 2011    Key Record Dates
Results First Posted: December 24, 2015
Last Update Posted: December 24, 2015
Last Verified: November 2015
Keywords provided by W.L.Gore & Associates:
Complex ventral incisional hernia repair
reapproximation of the rectus abdominis muscle
retrorectus or intraperitoneal placement technique
mobility for midline fascial closure
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes