Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497341
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2007-07-05
Brief Title:
Antibiotic Prophylaxis in Total Knee Prosthesis
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Randomised And Double Blind Study To Evaluate The Best Moment To Infuse The Prophylactic Antibiotic In Knee Arthroplasty Performed Under Ischemia
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 prophylaxisStandard cefuroxime 15 g iv 10 min before tourniquet placebo 10 min before tourniquet release cefuroxime 15 g iv 6h after closing surgical woundExperimental cefuroxime 15 g iv 10 min before tourniquet cefuroxime 15 g iv 10 min before tourniquet release cefuroxime 15 g iv 6h after closing surgical wound
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 prophylaxisStandard cefuroxime 15 g iv 10 min before tourniquet placebo 10 min before tourniquet release cefuroxime 15 g iv 6h after closing surgical woundExperimental cefuroxime 15 g iv 10 min before tourniquet cefuroxime 15 g iv 10 min before tourniquet release cefuroxime 15 g iv 6h after closing surgical woundThe infection rate with standard regimen is 34 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None