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Antibiotic Prophylaxis in Total Knee Prosthesis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497341
First Posted: July 6, 2007
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alex Soriano, Hospital Clinic of Barcelona
  Purpose
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.

Condition Intervention Phase
Infection Drug: cefuroxime Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomised And Double Blind Study To Evaluate The Best Moment To Infuse The Prophylactic Antibiotic In Knee Arthroplasty Performed Under Ischemia

Resource links provided by NLM:


Further study details as provided by Alex Soriano, Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • infection rate [ Time Frame: 12 months ]

Enrollment: 1332
Study Start Date: January 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
antibiotic is given before tourniquet inflation and before tourniquet release
Drug: cefuroxime
cefuroxime is administered at a dosage of 1.5 g before tourniquet inflation and release in experimental arm and only before tourniquet inflation in control arm
Placebo Comparator: 2
antibiotic is given before tourniquet inflation
Drug: placebo
cefuroxime 1.5 g IV before tourniquet inflation + placebo before tourniquet release + cefuroxime 1.5 g IV 6 h after surgery

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

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing knee arthroplasty

Exclusion Criteria:

  • patients allergic to penicillin
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497341


Locations
Spain
Hospital Clínic
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Alex Soriano, MD Hospital Clínical
  More Information

Responsible Party: Alex Soriano, Consultant of infectious diseases, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00497341     History of Changes
Other Study ID Numbers: PTR2007
First Submitted: July 5, 2007
First Posted: July 6, 2007
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Alex Soriano, Hospital Clinic of Barcelona:
infection after total knee arthroplasty

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefuroxime
Cefuroxime axetil
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents