Trials / Completed
CompletedNCT00617357
Repair of Infected or Contaminated Hernias
A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- LifeCell · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LTM (Strattice Reconstructive Tissue Matrix) | Surgical mesh |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2008-02-18
- Last updated
- 2015-12-01
- Results posted
- 2015-12-01
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00617357. Inclusion in this directory is not an endorsement.