Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601803
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Surgiphor Us in TSA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Surgiphor sterile Povidone-Iodine Wound Irrigation on Rate of Positive Deep Culture and NGS in Primary Total Shoulder Arthroplasty- a Prospective Randomized Pilot Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bacteria is occasionally present in the shoulder during shoulder arthroplasty surgery and is hypothesized to increase the risk of failure of the prosthesis Surgiphor sterile Povidone-Iodine wound irrigation is a solution used in orthopaedic surgery and other surgical fields to kill bacteria intraoperatively The Iodine dissociates from complex and has antimicrobial properties causing cell death of bacteria fungi and viruses through interactions with proteins nucleotides and fatty acids in the cytoplasm and cytoplasmic membrane
This study examines the use of Povidone-Iodine during primary shoulder arthroplasty
This study examines the use of Povidone-Iodine during primary shoulder arthroplasty
Detailed Description:
The purpose of this study is to determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty
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