Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567808
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Prevention of Infections in Cardiac Surgery PICS a Cluster-randomized Factorial Cross-over Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prevention of Infections in Cardiac Surgery PICS a Cluster-randomized Factorial Cross-over Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
PICS
Brief Summary:
The goal of this pragmatic multi-centre factorial cluster randomized cross-over trial is to assess the efficacy of a combination of cefazolin plus vancomycin compared to cefazolin monotherapy as well as a comparison of short versus long-term prophylaxis with four study arms 1 cefazolin short-term 2 cefazolin long-term 3 cefazolin plus vancomycin short-term and 4 cefazolin plus vancomycin long-term
Detailed Description:
Although antibiotic prophylaxis is considered the cornerstone of prevention for sternal surgical site infections s-SSIs the most effective antimicrobial regimen and optimal duration remain unclear There is a pressing need to determine how best to prevent sternal surgical site infections and at the same time reduce adverse events from unnecessary antibiotic exposure Currently due to the lack of evidence unproven approaches prevail and adherence to guidelines is poor Rigorous randomized controlled trials data are needed for improved patient care
A factorial cluster randomized cross-over trial a design not used previously in this field will address these gaps To date we have successfully enrolled close to 6000 eligible patients in the vanguard study and have shown that the trial as planned is feasible and operationally highly cost-effective
A factorial cluster randomized cross-over trial a design not used previously in this field will address these gaps To date we have successfully enrolled close to 6000 eligible patients in the vanguard study and have shown that the trial as planned is feasible and operationally highly cost-effective
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