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Repair of Infected or Contaminated Hernias

NCT00617357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2015-12-01

Study results available
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Summary

This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites. Three interim analyses are planned to examine the incidence of surgical site events, postoperative resumption of activities and hernia recurrence.

Conditions

  • Hernia

Interventions

DEVICE

LTM (Strattice Reconstructive Tissue Matrix)

Surgical mesh

Sponsors & Collaborators

  • LifeCell

    lead INDUSTRY

Principal Investigators

  • Kamal Itani, MD · Boston VA Healthcare System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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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 NCT00617357 on ClinicalTrials.gov