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

NCT01325792 | Completed Results

• 1 other identifier: CS155
• Study Type: observational
• Target: 104
• Locations: 2 countries
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (1)

• Hernia Recurrence Rate

  Investigator confirmed hernia recurrence by physical examination

  at about 24 months

Secondary Outcomes (1)

• Early and Long-term Complication Rates

  after surgery (day 1) to 24 months

Study Arms (1)

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

Interventions

GORE® BIO-A® Tissue Reinforcement 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.

Also known as: Biosynthetic Mesh

GORE® BIO-A® Tissue Reinforcement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

general and teaching hospitals

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (9)

UCSD Department of Surgery

San Diego, California, 92103, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Mount Sinai Medical Center

New York, New York, 10021, United States

Location

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

Cleveland, Ohio, 44106, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29607, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Canisius-Wilhelmina Ziekenhuis

Nijmegen, The Netherlands, Netherlands

Location

Results Point of Contact

• Title: Lori Norton, PhD
• Organization: W. L. Gore & Associates, Inc., Sponsor

lnorton@wlgore.com

800-437-8181

Study Officials

• Michael Rosen, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 30, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 24, 2015
• Results First Posted: December 24, 2015

Record last verified: 2015-11

Locations

US (8); NL (1)