Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty

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

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

Study Overview

• Status: Completed
• Conditions: Total Hip and Knee Arthroplasties
• Intervention / Treatment: Drug: Teicoplanin; Drug: β-lactams or ciprofloxacin

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 Type: Interventional
• Enrollment (Actual): 616
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Athens
    • Maroussi, Athens, Greece, 14527
      • 2nd Department of Orthopedics, KAT Hospital
    • Maroussi, Athens, Greece, 14527
      • 3rd Department of Orthopedics, KAT Hospital
    • Maroussi, Athens, Greece, 14527
      • 4th Department of Orthopedics, KAT Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Surgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty.	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; Other Names: Glycopeptide
Active Comparator: 2; 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; Multiple doses for up to six consecutive days; Other Names: Cephalosporins or ciprofloxacin or penicillincs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Athens
• Collaborators: KAT Hospital of Athens
• Investigators: Study Chair: Helen Giamarellou, MD, PhD, 4th Department of Internal Medicine, University of Athens, Medical School, Greece; Principal Investigator: Amyntas Varvaroussis, MD, 3rd Department of Orthopedics, KAT Hospital, Maroussi, Greece; Principal Investigator: Panagiotis Papadelis, MD, 2nd Department of Orthopedics, KAT Hospital, Maroussi, Greece; Principal Investigator: Vassilios Nikolaidis, MD, 4th Department of Orthopedics, KAT Hospital, Maroussi, Greece; Study Director: Antonios Papadopoulos, MD, PhD, 4th Department of Internal Medicine, University of Athens, Medical School, Greece

Publications and helpful links

General Publications

• Soriano A, Popescu D, Garcia S, Bori G, Martinez 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. doi: 10.1007/s10096-005-0073-z.
• Wilson AP, Gruneberg RN, Neu H. Dosage recommendations for teicoplanin. J Antimicrob Chemother. 1993 Dec;32(6):792-6. doi: 10.1093/jac/32.6.792. No abstract available.
• 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. doi: 10.1007/s004020050306.

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 18, 2008
• First Posted (Estimate): July 21, 2008

Study Record Updates

• Last Update Posted (Estimate): July 21, 2008
• Last Update Submitted That Met QC Criteria: July 18, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: prophylaxis; arthroplasty; surgical site infections; teicoplanin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin; Lactams; beta-Lactams; Cephalosporins; Teicoplanin
• Other Study ID Numbers: TEICO01