Evaluation of VSS Antibiotic Prophylaxis in Prosthetic Surgery (MRSA)

Last updated: May 6, 2024
Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

There isn't an intervention name because the study is observational and has only one group.

Clinical Study ID

NCT06403254
MRSA
  • Ages > 40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion

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

Study Design

Total Participants: 700
Treatment Group(s): 1
Primary Treatment: There isn't an intervention name because the study is observational and has only one group.
Phase:
Study Start date:
September 20, 2022
Estimated Completion Date:
November 30, 2024

Study 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

Connect with a study center

  • Istitutio Ortopedico Galeazzi Sede San Siro

    Milan, Lumbardy 20148
    Italy

    Active - Recruiting

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