Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty

Phase 4

Completed

• Conditions: Total Hip and Knee Arthroplasties
• Interventions: Drug: β-lactams or ciprofloxacin; Drug: Teicoplanin

• Registration Number: NCT00719056
• Lead Sponsor: University of Athens

Brief Summary

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

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

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-12
• Study Completion: 2007-12
• Status Verified: 2008-07
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-18
• Last Update Submitted: 2008-07-18
• Study First Posted: 2008-07-21
• Last Update Posted: 2008-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 616

Inclusion Criteria

• Patients admitted for total hip arthroplasty
• Patients admitted for total knee arthroplasty

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	β-lactams or ciprofloxacin	Surgical chemoprophylaxis with multiple dose of other antimicrobials for up to six consecutive days for total hip or knee arthroplasty.
1	Teicoplanin	Surgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

2nd Department of Orthopedics, KAT Hospital; 🇬🇷 Maroussi, Athens, Greece

3rd Department of Orthopedics, KAT Hospital; 🇬🇷 Maroussi, Athens, Greece

4th Department of Orthopedics, KAT Hospital; 🇬🇷 Maroussi, Athens, Greece