Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633588
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Decolonization Efficacy of Polyhexanide vs Mupirocin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Surgical Prophylaxis Assessing Decolonization Efficacy of Polyhexanide Versus Mupirocin and Chlorhexidine in Decolonizing Staphylococcus Aureus Preoperatively in Elective Spine Surgery SPADE A Pilot Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
SPADE
Brief Summary:
This pilot randomized controlled trial evaluates the feasibility tolerability and preliminary efficacy of a decolonization regimen using polyhexanide in reducing Staphylococcus aureus colonization in the preoperative phase of elective spine surgery compared to the standard mupirocin and chlorhexidine regimen The trial involves 24 participants randomized into two groups one receiving polyhexanide and the other receiving mupirocin and chlorhexidine The primary outcome is the randomization rate with secondary outcomes including other feasibility outcomes tolerability and efficacy measures such as the reduction in S aureus colony-forming units CFUs and changes in the nasal and skin microbiome composition
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