Clinical trial NCT00892333: Large Abdominal Hernia Repair With SurgiMend 3.0
Official title: Repair of Large Abdominal Hernia Defects By A Novel Biologic Mesh: A Prospective Multi-Center Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Keywords: Repair of a large hernia with SurgiMend 3.0, a biologic mesh
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: Boston Medical Center
name: Cook County Hospital
name: University of Southern California
name: Yale University
name: Oregon Health and Science University
name: State University of New York - Upstate Medical University
First posted: 2009-05-04
Enrollment: 122
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with surgical conditions such as i) open abdomen after a damage control operation for a traumatic or non-traumatic surgical emergency, ii) removal of infected prosthetic materials from a previous abdominal hernia repair, iii) iatrogenic injury of the bowel during adhisiolysis for repair of a large abdominal hernia, iv) contaminated operative field due to presence of an ostomy or the need for additional surgical procedures.

Brief summary: The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being that such rate will be less than 20% at one year, representing a 50% reduction over the historic rate of 40%.


Eligibility criteria: Inclusion Criteria:

All three of the following criteria must be present for enrollment into the study:

* Large abdominal hernia
* Inability to close the fascia primarily
* Contra-indication for the use of synthetic mesh
* Age \> 18 years

Exclusion Criteria:

* Use of SurgiMend 3.0 to simply reinforce a complete closure of the fascia performed either primarily or sequentially or by component separation technique
* Inability to close the skin over the SurgiMend 3.0

Primary outcomes:
measure: Hernia recurrence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County/University of Southern California Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Chicago
country: United States
facility: Cook County Hospital
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Syracuse
country: United States
facility: State University of New York (SUNY), Upstate Medical Center
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma University
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University (OHSU)
state: Oregon
Study officials:
affiliation: Massachusetts General Hospital/ Harvard University
name: George C Velmahos, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: