Clinical trial NCT01325792: Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement
Official title: Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biosynthetic Material for Midline Fascial Closure Reinforcement
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2011-03-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: general and teaching hospitals

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%.

Eligibility criteria: 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

Primary outcomes:
measure: Hernia Recurrence Rate
timeFrame: at about 24 months
Secondary outcomes:
measure: Early and Long-term Complication Rates
timeFrame: after surgery (day 1) to 24 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Department of Surgery
state: California
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: New York City
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Cleveland
country: United States
facility: Case Medical Center, Case Western Reserve University, Case Western Reserve University
state: Ohio
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
state: The Netherlands
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Michael Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References: