Evaluation of VSS Antibiotic Prophylaxis in Prosthetic Surgery (MRSA)

NCT ID: NCT06403254

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-20

Study Completion Date

2024-11-30

Brief Summary

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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

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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

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Infection in Bone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

Follow-up after surgey

Intervention Type PROCEDURE

Eligibility Criteria

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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

\-
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istitutio Ortopedico Galeazzi Sede San Siro

Milan, Lumbardy, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Giorgio Oriani, Physician

Role: primary

0039-2-4878 ext. 286

Role: backup

Other Identifiers

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MRSA

Identifier Type: -

Identifier Source: org_study_id

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