Overview

This trial is active, not recruiting.

Condition ventral incisional hernia
Treatment gore bio-a tissue reinforcement
Sponsor W.L.Gore & Associates
Start date February 2011
End date December 2014
Trial size 104 participants
Trial identifier NCT01325792, CS155

Summary

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%.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
primary or recurrent anterior abdominal wall hernia
gore bio-a tissue reinforcement Biosynthetic Mesh
Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure

Primary Outcomes

Measure
Hernia recurrence rate
time frame: at about 24 months

Secondary Outcomes

Measure
Early and long-term complication rates
time frame: after surgery (day 1) to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Bioabsorbable Material for Midline Fascial Closure Reinforcement
Principal investigator Michael Rosen, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by W.L.Gore & Associates.