Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-05 @ 6:06 PM
Study NCT ID:
NCT00617357
Status:
COMPLETED
Last Update Posted:
2015-12-01
First Post:
2008-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Repair of Infected or Contaminated Hernias
Sponsor:
LifeCell
Organization:
Study Overview
Official Title:
A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RICH
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: