Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03938467
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2019-05-02
Brief Title:
Irrisept CAcnes Study
Sponsor:
Orthopaedic Associates of Michigan PC
Organization:
Orthopaedic Associates of Michigan PC
Study Overview
Official Title:
Effect of Antiseptic Irrigation With 005 Chlorhexidine Gluconate Irrisept on Incidence of Cutibacterium Acnes in Shoulder Arthroplasty
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
Recruiting
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:
A Prospective Randomized Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 005 Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes
Detailed Description:
The purpose of this prospective randomized control trial is to access outcomes of positive culture growth of C acnes from specimens obtained from the shoulders of patients undergoing primary shoulder arthroplasty whose intraoperative management includes Irrisept antiseptic irrigation and compare it to patients whose management includes standard of care prophylaxis wipes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None