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

Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biosynthetic Material for Midline Fascial Closure Reinforcement

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.

Study Overview

• Status: Completed
• Conditions: Ventral Incisional Hernia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• Netherlands
  • The Netherlands
    • Nijmegen, The Netherlands, Netherlands
      • Canisius-Wilhelmina Ziekenhuis
• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Department of Surgery
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • New York City, New York, United States, 10021
      • Mount Sinai Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Medical Center, Case Western Reserve University, Case Western Reserve University
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Greenville Hospital System
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

general and teaching hospitals

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Biosynthetic Mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia Recurrence Rate	Investigator confirmed hernia recurrence by physical examination	at about 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early and Long-term Complication Rates	Surgical site abdominal wound event rate	after surgery (day 1) to 24 months

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Michael Rosen, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 28, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Estimate): December 24, 2015
• Last Update Submitted That Met QC Criteria: November 18, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: 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: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: CS155