Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379919
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-18
Brief Title:
Wound Irrigation Comparative Effectiveness Study
Sponsor:
Orthopaedic Education and Research Institute dba Hoag Orthopedics
Organization:
Orthopaedic Education and Research Institute dba Hoag Orthopedics
Study Overview
Official Title:
Cutibacterium Acnes Removal by Wound Irrigation With Normal Saline Versus Irrisept During Total Shoulder Arthroplasty
Status:
RECRUITING
Status Verified Date:
2024-04
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 of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation Group 1 or Irrisept Irrigation Group 2 Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None