Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty

Total Hip and Knee Arthroplasties Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719056
• Other study ID #: TEICO01
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2008
• Last updated: July 18, 2008
• Start date: August 2004
• Est. completion date: December 2007

Study information

• Verified date: July 2008
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 616
• Est. completion date: December 2007
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgical Wound Infection
• Total Hip and Knee Arthroplasties

Intervention

Drug:
• Teicoplanin
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
• ß-lactams or ciprofloxacin
Multiple doses for up to six consecutive days

Locations

Country	Name	City	State
Greece	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Athens	KAT Hospital of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (3)

Nehrer S, Thalhammer F, Schwameis E, Breyer S, Kotz R. Teicoplanin in the prevention of infection in total hip replacement. Arch Orthop Trauma Surg. 1998;118(1-2):32-6. — View Citation

Soriano A, Popescu D, García S, Bori G, Martínez JA, Balasso V, Marco F, Almela M, Mensa J. Usefulness of teicoplanin for preventing methicillin-resistant Staphylococcus aureus infections in orthopedic surgery. Eur J Clin Microbiol Infect Dis. 2006 Jan;25(1):35-8. — View Citation

Wilson AP, Grüneberg RN, Neu H. Dosage recommendations for teicoplanin. J Antimicrob Chemother. 1993 Dec;32(6):792-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No