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

Ventral Incisional Hernia Clinical Trial

— COBRA  

Official title:

Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biosynthetic Material for Midline Fascial Closure Reinforcement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325792
• Other study ID #: CS155
• Status: Completed
• Phase: N/A
• First received: March 28, 2011
• Last updated: November 18, 2015
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Incisional Hernia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	Canisius-Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
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	Indiana University	Indianapolis	Indiana
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai Medical Center	New York City	New York
United States	UCSD Department of Surgery	San Diego	California
United States	Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia Recurrence Rate	Investigator confirmed hernia recurrence by physical examination	at about 24 months	No
Secondary	Early and Long-term Complication Rates	Surgical site abdominal wound event rate	after surgery (day 1) to 24 months	No