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

NCT ID: NCT01325792

Last Updated: 2015-12-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-12-31

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.

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%.

Conditions

Ventral Incisional Hernia

Keywords

Complex ventral incisional hernia repair; reapproximation of the rectus abdominis muscle; retrorectus or intraperitoneal placement technique; mobility for midline fascial closure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

GORE® BIO-A® Tissue Reinforcement

Single-staged open complex ventral incisional repair of primary or recurrent anterior abdominal wall hernia.

GORE® BIO-A® Tissue Reinforcement

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Biosynthetic Mesh

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

UCSD Department of Surgery

San Diego, California, United States

Indiana University

Indianapolis, Indiana, United States

Washington University

St Louis, Missouri, United States

Mount Sinai Medical Center

New York, New York, United States

Case Medical Center, Case Western Reserve University, Case Western Reserve University

Cleveland, Ohio, United States

Greenville Hospital System

Greenville, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Canisius-Wilhelmina Ziekenhuis

Nijmegen, The Netherlands, Netherlands

Countries

United States; Netherlands

Other Identifiers

CS155

Identifier Type: -

Identifier Source: org_study_id