Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-28 @ 6:12 AM
Study NCT ID:
NCT01594450
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2012-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Meshes in Infected Fields: a Randomized Controlled Trial
Sponsor:
University Hospital, Lille
Organization:
Study Overview
Official Title:
Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study
Status:
COMPLETED
Status Verified Date:
2019-08
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:
SIMBIOSE
Brief Summary:
The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. The primary endpoint is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain, quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be included.
Detailed Description:
Comparison between standard wound care and the use of biological meshes in infected fields
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-A00059-34 | OTHER | ID-RCB number, ANSM | View |