Hospital Clínic
Barcelona, Catalonia, 08036, Spain
NCT Number: NCT00497341
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.
Looking for future studies?
Notify Me18 year–90 year
All sexes
Interventional
Phase 4
Barcelona, Catalonia, 08036, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
cefuroxime 1.5 g IV before tourniquet inflation + placebo before tourniquet release + cefuroxime 1.5 g IV 6 h after surgery
Time frame: 12 months
Hospital Clinic of Barcelona
Other
Randomised And Double Blind Study To Evaluate The Best Moment To Infuse The Prophylactic Antibiotic In Knee Arthroplasty Performed Under Ischemia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01264055
Bronchial Diseases, Bronchiectasis
Stanford, California, United States
View Trial DetailsNCT07673484
Allergic Contact Dermatitis, Cicatrix
Küçükçekmece, Istanbul, Turkey (Türkiye)
View Trial DetailsNCT00342589
Bacterial Infections and Mycoses, Infection
Bethesda, Maryland, United States
View Trial DetailsNCT07256405
Bone, Fracture
Marseille, Bouches-du-Rhône, France
View Trial Details