Evaluating antibiotic use in prosthetic surgery to prevent infections
Seeking Bacterial Prevalence for Targeted Pre-Surgical Antibiotic Prophylaxis in Prosthetic Surgery
This study is testing if giving antibiotics before major joint surgeries, like knee and hip replacements, can help prevent infections in people over 40.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan, Lumbardy) |
| Trial ID | NCT06403254 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the effectiveness of antibiotic prophylaxis in preventing infections during major orthopedic surgeries, specifically total knee arthroplasty (TKA) and total hip arthroplasty (THA). Patients over 40 years old will receive standard first-generation cephalosporin antibiotics before surgery, followed by monitoring for infections post-operatively. The study aims to evaluate the prevalence of infections, particularly those caused by MRSA, and the potential benefits of using glycopeptides as an alternative prophylactic measure. Participants will undergo clinical evaluations at multiple time points, including 6 and 12 months post-surgery.
Who should consider this trial
Good fit: Ideal candidates are males and females over 40 years old undergoing TKA or THA surgery with ASA classification II or III.
Not a fit: Patients with pre-existing infections, immunocompromised conditions, or coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved infection prevention strategies in orthopedic surgeries, enhancing patient outcomes.
How similar studies have performed: Previous studies have shown success in using antibiotic prophylaxis in orthopedic surgeries, but this specific approach with glycopeptides is less commonly evaluated.
Eligibility criteria
Show full inclusion / exclusion 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 -
Where this trial is running
Milan, Lumbardy
- Istitutio Ortopedico Galeazzi Sede San Siro — Milan, Lumbardy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.