Clinical trial NCT00719056: Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty
Official title: Efficacy of Teicoplanin for the Prevention of Surgical Site Infections After Total Hip or Knee Arthroplasty: A Prospective, Open-Label Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Hip and Knee Arthroplasties
Keywords: teicoplanin
prophylaxis
arthroplasty
surgical site infections
Lead sponsor: University of Athens
Sponsor class: OTHER
Collaborators: name: KAT Hospital of Athens
First posted: 2008-07-21
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Two years
Secondary outcomes:
measure: 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.
timeFrame: Two years
Other outcomes:
Locations:
city: Maroussi
country: Greece
facility: 2nd Department of Orthopedics, KAT Hospital
state: Athens
city: Maroussi
country: Greece
facility: 3rd Department of Orthopedics, KAT Hospital
state: Athens
city: Maroussi
country: Greece
facility: 4th Department of Orthopedics, KAT Hospital
state: Athens
Study officials:
affiliation: 4th Department of Internal Medicine, University of Athens, Medical School, Greece
name: Helen Giamarellou, MD, PhD
role: STUDY_CHAIR
affiliation: 3rd Department of Orthopedics, KAT Hospital, Maroussi, Greece
name: Amyntas Varvaroussis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Department of Orthopedics, KAT Hospital, Maroussi, Greece
name: Panagiotis Papadelis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 4th Department of Orthopedics, KAT Hospital, Maroussi, Greece
name: Vassilios Nikolaidis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 4th Department of Internal Medicine, University of Athens, Medical School, Greece
name: Antonios Papadopoulos, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.