Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203541
Status:
TERMINATED
Last Update Posted:
2007-11-19
First Post:
2005-09-12
Brief Title:
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections
Sponsor:
Tyco Healthcare Group
Organization:
Tyco Healthcare Group
Study Overview
Official Title:
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections in Subjects Who Have Undergone Cardiac Surgical Procedures Requiring Median Sternotomy
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Reallocation of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this pivotal study is to determine if a new antimicrobial dressing applied to the sternal incisions of cardiac surgical subjects will demonstrate a decreased cumulative incidence rateCI of localized superficial infections at the sternal incisional site as compared to the control group regular non-antimicrobial dressing
Detailed Description:
None
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