Evaluation of VSS Antibiotic Prophylaxis in Prosthetic Surgery (MRSA) (MRSA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infection in Bone
• Intervention / Treatment: Procedure: There isn't an intervention name because the study is observational and has only one group.

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

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

Study Locations

• Italy
  • Lumbardy
    • Milan, Lumbardy, Italy, 20148
      • Recruiting
      • Istitutio Ortopedico Galeazzi Sede San Siro
      • Contact: Giorgio Oriani, Physician; Phone Number: 286 0039-2-4878; Email: giorgio.oriani@grupposandonato.it
      • Contact: Email: gorian@alice.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All patients, in a consecutive serie, based on criteria over indicated

Description

Inclusion Criteria:

Patiens male and female, old more than 40 years TKA or THA Surgeryntervento di chirurgia protesica ASAC II or even III, without any acute coexisting disease Informed consent -

Exclusion Criteria:Patients with infection before surgery Immunocompromise patient (e.g. Diabeties with glicate HB indicating a metabolic bad compensation) Patient with coagulation disorders Pregnancy Informed consent denied

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infections	Orthopedic clinical control , with or without exams	1 year after the surgery

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MRSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No