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Strattice in Repair of Inguinal Hernias

NCT00681291 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2016-05-10

Study results available
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Summary

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.

Conditions

  • Hernia, Inguinal

Interventions

DEVICE

Inguinal hernia repair with Ultrapro

surgical mesh (15x15cm) to support Lichtenstein repair

DEVICE

Inguinal hernia repair with Strattice

Surgical mesh (10x16) used to support Lichtenstein repair

Sponsors & Collaborators

  • LifeCell

    lead INDUSTRY

Principal Investigators

  • Charles Bellows, MD, FACS · Tulane University

  • Samir Awad, MD, FACS · Baylor College of Medicine

  • Robert Fitzgibbons, MD, FACS · Creighton University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00681291 on ClinicalTrials.gov