Large Abdominal Hernia Repair With SurgiMend 3.0

NCT00892333 | Completed

• 1 other identifier: TEI-002
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 8

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%.

Conditions

Hernia

Keywords

Repair of a large hernia with SurgiMend 3.0, a biologic mesh

Outcome Measures

Primary Outcomes (1)

• Hernia recurrence

  1 year

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Massachusetts General Hospital: collaborator
• Boston Medical Center: collaborator
• Cook County Hospital: collaborator
• University of Southern California: collaborator
• Yale University: collaborator
• Oregon Health and Science University: collaborator
• State University of New York - Upstate Medical University: collaborator

Study Sites (8)

Los Angeles County/University of Southern California Medical Center

Los Angeles, California, 90033, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Cook County Hospital

Chicago, Illinois, 60612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

State University of New York (SUNY), Upstate Medical Center

Syracuse, New York, 13210, United States

Location

Oklahoma University

Oklahoma City, Oklahoma, 73117, United States

Location

Oregon Health and Science University (OHSU)

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• George C Velmahos, MD, Ph.D.

  Massachusetts General Hospital/ Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: May 4, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

US (8)