Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274625
Status:
COMPLETED
Last Update Posted:
2014-11-12
First Post:
2006-01-09
Brief Title:
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
Sponsor:
Cook Group Incorporated
Organization:
Cook Group Incorporated
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-11
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:
None
Brief Summary:
The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture closure alone in preventing an incisional hernia after open bariatric surgery
Detailed Description:
This will be a prospective randomized clinical trial comparing outcomes of use of a sublay of Surgisis Gold Graft for tissue reinforcement as compared to suture closure alone in evaluating incidence of incisional hernias Prior to undergoing open bariatric surgery patients will be randomized to receive either Surgisis Gold Graft or suture closure alone Subjects will be seen for follow-up visits at six weeks three months six months one year and two years post-operatively Patients may see their primary care physician for the one and two follow-up visits
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-007 | None | None | None |