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

Completed

Conditions studied: Ventral Incisional Hernia

In brief

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.

Key facts

Study ID

NCT01325792

Run by

W.L.Gore & Associates

People needed

104

Starts

2011-02-01

Expected to finish

2014-12-01

Last updated by the study team

2015-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• Subjects in which intraoperatively untreated cancer was found

Where it is running

• 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

Full record on ClinicalTrials.gov

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