Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty

Study Overview
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Brief Summary
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This is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with teicoplanin or with other antibiotics. The study is aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections

Detailed Description
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This is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with a single dose of teicoplanin or with multiple doses of other antibiotics according to the habits of the attending physicians aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections

Official Title
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Efficacy of Teicoplanin for the Prevention of Surgical Site Infections After Total Hip or Knee Arthroplasty: A Prospective, Open-Label Randomized Study

Conditions
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Total Hip and Knee Arthroplasties

Intervention / Treatment
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* Drug: Teicoplanin
* Drug: β-lactams or ciprofloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted for total hip arthroplasty Patients admitted for total knee arthroplasty Exclusion Criteria: Revision arthroplasty History of any infection within the preceding two months History of an operation in the same hip or knee for other causes Known history of allergy to the studied drug Pregnancy or lactation Any antibiotic therapy in the week before operation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Surgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty. | Drug: Teicoplanin<br>* The selected dose was 10mg/kg and it was given intravenously by a catheter inserted under aseptic conditions in a forearm vein within 15 minutes; it was diluted in one 5% glucose solution of a 50 ml final volume<br>* Other names: Glycopeptide;|
| Active Comparator: 2<br>Surgical chemoprophylaxis with multiple dose of other antimicrobials for up to six consecutive days for total hip or knee arthroplasty. | Drug: β-lactams or ciprofloxacin<br>* Multiple doses for up to six consecutive days<br>* Other names: Cephalosporins or ciprofloxacin or penicillincs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of single dose teicoplanin compared with comparator agents in the prevention of surgical site infections after total hip or knee arthroplasty. |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of single dose teicoplanin compared with comparator agents in the separate prevention of superficial or deep surgical site infections after total hip or knee arthroplasty. |  | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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teicoplanin, prophylaxis, arthroplasty, surgical site infections