Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403254
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-01-26
Brief Title:
Evaluation of VSS Antibiotic Prophylaxis in Prosthetic Surgery MRSA
Sponsor:
IRCCS Ospedale Galeazzi-SantAmbrogio
Organization:
IRCCS Ospedale Galeazzi-SantAmbrogio
Study Overview
Official Title:
Seeking Bacterial Prevalence for Targeted Pre-Surgical Antibiotic Prophylaxis in Prosthetic Surgery
Status:
RECRUITING
Status Verified Date:
2024-02
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:
MRSA
Brief Summary:
based on international guide lines antibiotic prophylaxis in Orthoaedic major surgery has to be done with a Cephalosporin 1st generation eg Cefazolin 1 g 30 before surgery
Since more than 10 years ago the investigators started evaluatinf infections in such a surgery well demosntrating a level below 1 and more important a responsability of MRSA considering Cephalosporin 1st generation useful but not determinat in such a surgery investigators consider the use of a Glycopepide Vancocyn 1 g in Very short The primary outcome is to evaluate the validity of such proposal performing a study of prevalence
Since more than 10 years ago the investigators started evaluatinf infections in such a surgery well demosntrating a level below 1 and more important a responsability of MRSA considering Cephalosporin 1st generation useful but not determinat in such a surgery investigators consider the use of a Glycopepide Vancocyn 1 g in Very short The primary outcome is to evaluate the validity of such proposal performing a study of prevalence
Detailed Description:
Patients enrolled in the study have to follow rhese steps
T0 Clinical evaluation and Cephalosporin VSS prophylaxis as usual T1 Surgery for TKA or THA T2 Post-operative -- control and if an infextion is supposed Coltural examination and ABG T3 Post-op orthopedic control at 6 months to evaluate any possible infection T4 Post-op clinical valuation at 12 months with the same goal
T0 Clinical evaluation and Cephalosporin VSS prophylaxis as usual T1 Surgery for TKA or THA T2 Post-operative -- control and if an infextion is supposed Coltural examination and ABG T3 Post-op orthopedic control at 6 months to evaluate any possible infection T4 Post-op clinical valuation at 12 months with the same goal
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?:
None
Is an FDA AA801 Violation?:
None