CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 83 enrolled
Drug / intervention
LTM (Strattice Reconstructive Tissue Matrix)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00617357
NCT00617357N/ACompleted
CompareCT.gov

A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM

LifeCell·interventional·Posted Feb 18, 2008·Updated Dec 1, 2015

In Brief

A clinical study evaluating LTM (Strattice Reconstructive Tissue Matrix) for Hernia. Completed, enrolled 83 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHernia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 18, 2008
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.4 years ago

Interventions

LTM (Strattice Reconstructive Tissue Matrix)device

Surgical mesh