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Sponsored by: |
LifeCell |
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Information provided by: | LifeCell |
ClinicalTrials.gov Identifier: | NCT00681291 |
This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh. Performance and outcomes measures to be compared include postoperative resumption of activities of daily living, nature and incidence of short- and long-term pain and complications, and incidence of hernia recurrence.
Condition | Intervention | Phase |
---|---|---|
Hernia, Inguinal |
Device: Inguinal hernia repair with Ultrapro Device: Inguinal hernia repair with Strattice |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias |
Estimated Enrollment: | 170 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
lightweight polypropylene mesh
|
Device: Inguinal hernia repair with Ultrapro
surgical mesh (15x15cm) to support Lichtenstein repair
|
2: Active Comparator
Strattice
|
Device: Inguinal hernia repair with Strattice
Surgical mesh (10x16) used to support Lichtenstein repair
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Hospital of St Rafael | Recruiting |
New Haven, Connecticut, United States, 06511 | |
Contact: Scott Helton 203-789-3501 | |
Principal Investigator: Scott Helton, MD, FACS | |
United States, Louisiana | |
Tulane University Health Sciences Center | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Nancy Logan 504-988-7889 | |
Principal Investigator: Charles Bellows, MD, FACS | |
United States, Nebraska | |
Creighton University | Recruiting |
Omaha, Nebraska, United States, 68178 | |
Contact: Rene Christian 402-280-4538 | |
Principal Investigator: Robert J Fitzgibbons, Jr, MD, FACS | |
United States, North Carolina | |
North Carolina Specialty Hospital | Recruiting |
Durham, North Carolina, United States, 27704 | |
Contact: Lisa Edgerton 919-313-6026 | |
Principal Investigator: Phillip Shadduck, MD | |
United States, Oregon | |
Oregon Health Sciences University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Debra Drake 505-494-4949 | |
Principal Investigator: Robert Martindale, MD, FACS | |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Samir Awad 713-794-8737 | |
Principal Investigator: Samir Awad, MD, FACS |
Principal Investigator: | Charles Bellows, MD, FACS | Tulane University School of Medicine |
Principal Investigator: | Samir Awad, MD, FACS | Baylor College of Medicine |
Principal Investigator: | Robert Fitzgibbons, MD, FACS | Creighton University |
Responsible Party: | Lifecell Corporation ( Randi Rutan ) |
Study ID Numbers: | LFC2007.04.01 |
Study First Received: | May 15, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00681291 |
Health Authority: | United States: Institutional Review Board |
surgical mesh inguinal hernia repair chronic groin pain |
Pathological Conditions, Anatomical Hernia Hernia, Abdominal Pain Hernia, Inguinal |