Antibiotic Prophylaxis in Total Knee Prosthesis
Information source: Hospital Clinic of Barcelona
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection
Intervention: cefuroxime (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hospital Clinic of Barcelona Official(s) and/or principal investigator(s): Alex Soriano, MD, Principal Investigator, Affiliation: Hospital Clínical
Overall contact: Alex Soriano, MD, Phone: 00-34-932275708, Email: asoriano@clinic.ub.es
Summary
Knee prosthesis infection is a severe complication. The use of a tourniquet during surgery
impairs the efficacy of the antibiotic prophylaxis. We hypothesize that the antibiotic
administration before tourniquet release decrease the infection rate. Methods: patients who
undergo a total knee arthroplasty will be randomized to receive one of the following
regimens of antibiotic prophylaxis: Standard: cefuroxime 1. 5 g i. v. 10 min before tourniquet
+ placebo 10 min before tourniquet release + cefuroxime 1'5 g i. v. 6h after closing surgical
wound. Experimental: cefuroxime 1. 5 g i. v. 10 min before tourniquet + cefuroxime 1. 5 g i. v.
10 min before tourniquet release + cefuroxime 1'5 g i. v. 6h after closing surgical wound.
Clinical Details
Official title: Randomised And Double Blind Study To Evaluate The Best Moment To Infuse The Prophylactic Antibiotic In Knee Arthroplasty Performed Under Ischemia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: infection rate
Detailed description:
Objective: when surgery is performed under ischemia, the ideal timing for the administration
of antibiotic prophylaxis has not been well defined. Currently, antibiotics are given 10
minutes before ischemia and the infection rate is about 3-5%. In 2005 we performed a study
where the efficacy of the standard prophylaxis was compared with a new regimen that
consisted in administering the antibiotic 10 min. before tourniquet release. The results
were positive although the difference was not statistically significant. In the present
study we are proposing a new protocol where the antibiotic is given 10 min. before the
inflation of tourniquet and 10 min. before its release. Methodology: all patients who
undergo a total knee arthroplasty will be randomized to receive one of the following
regimens of antibiotic prophylaxis: Standard: cefuroxime 1. 5 g i. v. 10 min before tourniquet
+ placebo 10 min before tourniquet release + cefuroxime 1'5 g i. v. 6h after closing surgical
wound. Experimental: cefuroxime 1. 5 g i. v. 10 min before tourniquet + cefuroxime 1. 5 g i. v.
10 min before tourniquet release + cefuroxime 1'5 g i. v. 6h after closing surgical wound. The
infection rate with standard regimen is 3. 4%. We believe that the new regimen will decrease
the rate of infection to 1%. To demonstrate differences between both arms, it will be
necessary to include 666 patients per arm.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients undergoing knee arthroplasty
Exclusion Criteria:
- patients allergic to penicillin
Locations and Contacts
Alex Soriano, MD, Phone: 00-34-932275708, Email: asoriano@clinic.ub.es
Hospital Clínic, Barcelona, Catalonia 08036, Spain; Recruiting Alex Soriano, MD, Phone: 00-34-932275708, Email: asoriano@clinic.ub.es Alex Soriano, MD, Principal Investigator
Additional Information
Starting date: January 2008
Last updated: February 18, 2009
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