ClinicalTrials.gg
Status unknownNCT06403254MRSAUpdated May 7, 2024

Evaluation of VSS Antibiotic Prophylaxis in Prosthetic Surgery (MRSA)

An observational study in Infection in Bone, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Status unknown at 1 site in Italy. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational

The sponsor has not verified this record recently (last verified Feb 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
40 Years and older
Sex
All
01

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.

Read the 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

02

Conditions studied

  • Infection in Bone
03

In context

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Eligibility criteria

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

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No

Interventions

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

    Follow-up after surgey

06

What researchers measure

Primary outcomes

  1. Infections

    Orthopedic clinical control , with or without exams

    Time frame: 1 year after the surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2022 (actual). Primary completion is estimated for Sep 2024, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2024
First posted
May 7, 2024
StartActual
Sep 20, 2022
Primary completionEst.
Sep 2024
CompletionEst.
Nov 2024
Last update
May 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06403254
Responsible party
Sponsor
First posted
May 7, 2024
Start date
Sep 20, 2022
Primary completion
Sep 2024 (estimated)
Completion
Nov 2024 (estimated)
Last update
May 7, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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