Antibiotic Prophylaxis in Total Knee Prosthesis

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Completed

CT.gov ID

NCT00497341

Collaborator

(none)

1,332

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: cefuroxime Drug: placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1332 participants

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

infection rate [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients undergoing knee arthroplasty

Exclusion Criteria:

patients allergic to penicillin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínic	Barcelona	Catalonia	Spain	08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator: Alex Soriano, MD, Hospital Clínical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alex Soriano, Consultant of infectious diseases, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT00497341

Other Study ID Numbers:

PTR2007

First Posted:

Jul 6, 2007

Last Update Posted:

Feb 19, 2016

Last Verified:

Feb 1, 2016

Keywords provided by Alex Soriano, Consultant of infectious diseases, Hospital Clinic of Barcelona

infection after total knee arthroplasty

Additional relevant MeSH terms:

Infections

Cefuroxime

Cefuroxime axetil

Study Results

No Results Posted as of Feb 19, 2016