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Completed

NCT Number: NCT00719056

Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty

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

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Key information

Conditions

Total Hip and Knee Arthroplasties Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

2nd Department of Orthopedics, KAT Hospital, Marousi, Athens, Greece

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teicoplanin

Drug

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

Other names: Glycopeptide

β-lactams or ciprofloxacin

Drug

Multiple doses for up to six consecutive days

Other names: Cephalosporins or ciprofloxacin or penicillincs

Primary outcomes

  1. 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.

    Time frame: Two years

Secondary outcomes

  1. 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.

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Collaborators

  • KAT Hospital of Athens

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2007
First posted
Jul 21, 2008
Registry last updated
Jul 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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