Repair Of Large Abdominal Hernia With SurgiMend 3.0

This study is currently recruiting participants.

Verified June 2011 by TEI Biosciences Inc.

First Received on April 29, 2009. Last Updated on June 6, 2011 History of Changes

Sponsor:	TEI Biosciences Inc.
Collaborators:	Massachusetts General Hospital Boston Medical Center Cook County Hospital University of Southern California Yale University
Information provided by:	TEI Biosciences Inc.
ClinicalTrials.gov Identifier:	NCT00892333

Purpose

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%.

Condition
Hernia

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Repair of Large Abdominal Hernia Defects By A Novel Biologic Mesh: A Prospective Multi-Center Observational Study

Resource links provided by NLM:

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by TEI Biosciences Inc.:

Estimated Enrollment:	100
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892333

Locations

United States, California
Los Angeles County/University of Southern California Medical Center	Recruiting
Los Angeles, California, United States, 90033
Contact: Demetrios Demetriades, MD, PhD demetria@usc.edu
Principal Investigator: Demetrios Demetriades, M.D., Ph.D.
United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Kimberly A. Davis, M.D. kimberly.davis@yale.edu
Principal Investigator: Kimberly A. Davis, M.D.
United States, Illinois
Cook County Hospital	Recruiting
Chicago, Illinois, United States, 60612
Contact: Andrew Dennis, DO ajddoc@gmail.com
Principal Investigator: Andrew Dennis, D.O., DME
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: George C Velmahos, MD, Ph.D. gvelmahos@partners.org
Principal Investigator: George C Velmahos, M.D., Ph.D.
Boston Medical Center	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Eric J Mahoney, MD Eric.Mahoney@bmc.org
Principal Investigator: Eric J Mahoney, M.D.

Sponsors and Collaborators

TEI Biosciences Inc.

Massachusetts General Hospital

Boston Medical Center

Cook County Hospital

University of Southern California

Yale University

Investigators

Principal Investigator:

George C Velmahos, MD, Ph.D.

Massachusetts General Hospital/ Harvard University

More Information

No publications provided

Responsible Party:	Yiannis Monovoukas, Ph.D. - President/CEO, TEI Biosciences Inc.
ClinicalTrials.gov Identifier:	NCT00892333 History of Changes
Other Study ID Numbers:	TEI-002
Study First Received:	April 29, 2009
Last Updated:	June 6, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by TEI Biosciences Inc.:

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

Additional relevant MeSH terms:

Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on February 09, 2012