NCT06403254

Evaluation of VSS Antibiotic Prophylaxis in Prosthetic Surgery (MRSA)

Seeking Bacterial Prevalence for Targeted Pre-Surgical Antibiotic Prophylaxis in Prosthetic Surgery

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

based on international guide lines, antibiotic prophylaxis in Orthoaedic major surgery has to be done with a Cephalosporin 1st generation (e.g. 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.

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

Conditions

• Infection in Bone

Interventions

Type	Name	Description
PROCEDURE	There isn't an intervention name because the study is observational and has only one group.	Follow-up after surgey

Timeline

• Start date: 2022-09-20
• Primary completion: 2024-09-01
• Completion: 2024-11-01
• First posted: 2024-05-07
• Last updated: 2024-05-07

Locations

1 site across 1 country: Italy