Antibiotic Prophylaxis in Total Knee Prosthesis

February 17, 2016 updated by: Alex Soriano, Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1332

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Hospital Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing knee arthroplasty

Exclusion Criteria:

  • patients allergic to penicillin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
infection rate
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Alex Soriano, MD, Hospital Clínical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

July 5, 2007

First Submitted That Met QC Criteria

July 5, 2007

First Posted (ESTIMATE)

July 6, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTR2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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