Antibiotic Prophylaxis in Total Knee Prosthesis - Full Text View

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 IV

MedlinePlus related topics:

Antibiotics Knee Replacement

ChemIDplus related topics:

Cefuroxime Cefuroxime axetil Cefuroxime sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Official Title:	Randomised And Double Blind Study To Evaluate The Best Moment To Infuse The Prophylactic Antibiotic In Knee Arthroplasty Performed Under Ischemia

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

infection rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1332
Study Start Date:	January 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator antibiotic is given before tourniquet inflation	Drug: placebo

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients undergoing knee arthroplasty

Exclusion Criteria:

patients allergic to penicillin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497341

Contacts


Contact: Alex Soriano, MD	00-34-932275708	asoriano@clinic.ub.es

Locations


Spain, Catalonia
	Hospital Clínic	Recruiting
	Barcelona, Catalonia, Spain, 08036
	Contact: Alex Soriano, MD 00-34-932275708 asoriano@clinic.ub.es
	Principal Investigator: Alex Soriano, MD

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators


Principal Investigator:	Alex Soriano, MD	Hospital Clínical

More Information

Responsible Party:	Hospital Clínic ( Alex Soriano )
Study ID Numbers:	PTR2007
First Received:	July 5, 2007
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00497341
Health Authority:	Spain: Ethics Committee

Keywords provided by Hospital Clinic of Barcelona:

infection after total knee arthroplasty

Study placed in the following topic categories:

Cefuroxime axetil

Cefuroxime

Ischemia

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Therapeutic Uses

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00497341