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

Completed

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%.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
GORE® BIO-A® Tissue Reinforcement	GORE® BIO-A® Tissue Reinforcement	Single-staged open complex ventral incisional repair of primary or recurrent anterior abdominal wall hernia.

Primary Outcome Measures

Name	Time	Method
Hernia Recurrence Rate	at about 24 months	Investigator confirmed hernia recurrence by physical examination

Secondary Outcome Measures

Name	Time	Method
Early and Long-term Complication Rates	after surgery (day 1) to 24 months	Surgical site abdominal wound event rate

Locations (9): UCSD Department of Surgery
🇺🇸
San Diego, California, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
Canisius-Wilhelmina Ziekenhuis
🇳🇱
Nijmegen, The Netherlands, Netherlands
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Greenville Hospital System
🇺🇸
Greenville, South Carolina, United States
Washington University
🇺🇸
St. Louis, Missouri, United States
Mount Sinai Medical Center
🇺🇸
New York City, New York, United States
Case Medical Center, Case Western Reserve University, Case Western Reserve University
🇺🇸
Cleveland, Ohio, United States