Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty

National and Kapodistrian University of Athens

Status and phase: Completed; Phase 4

Conditions: Total Hip and Knee Arthroplasties

Treatments: Drug: Teicoplanin; Drug: β-lactams or ciprofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT00719056

TEICO01

Details and patient eligibility

About

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

Full 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

Enrollment: 616 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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616 participants in 2 patient groups

1

Experimental group

Description:

Surgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty.

Treatment:

Drug: Teicoplanin

2

Active Comparator group

Description:

Surgical chemoprophylaxis with multiple dose of other antimicrobials for up to six consecutive days for total hip or knee arthroplasty.

Treatment:

Drug: β-lactams or ciprofloxacin