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Набира участници Фаза 4 NCT05447559

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Surgical Site Infection

Спонсор: Monash University

Налично на: БГ
Обобщение
This multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial will compare the incidence of surgical site infection and other healthcare associated infections, health economic and microbiological impact after intraoperative only (Arm A), to 24 hours (Arm B) and, to 48 hours (Arm C) of IV cefazolin and placebo postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery
Описание
This trial will evaluate the clinical effectiveness, health-economic outcomes and microbiological impact of intraoperative (only) compared with intraoperative plus postoperative prophylaxis durations in patients undergoing cardiac surgery. CALIPSO, a multicentre, adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial will examine the incidence proportion of SSI following cardiac surgery. Our three-intervention trial will compare: Arm A Administration of prophylaxis in intraoperative period only Arm B Administration of prophylaxis in intraoperative plus for 24 hours postoperatively Arm C Administration of prophylaxis in intraoperative plus for 48 hours postoperatively
Кой може да участва
Inclusion Criteria: \- Adult patients undergoing cardiac surgery involving a median sternotomy Exclusion Criteria: * Age \<18 years * American Society of Anesthesiology (ASA) 5 * Subjects with GFR \<40mL/min/1.73m2 or those requiring continuous renal replacement therapy, haemodialysis or peritoneal dialysis * Surgery for suspected or proven endocarditis or deep sternal wound infection * Documented cefazolin hypersensitivity * Documented methicillin resistant Staphylococcus aureus (MRSA) colonisation or infection in the 12-months prior to index surgery * Cardiac transplantation * Procedures involving insertion ventricular assist device or mechanical circulatory support device * Procedures not involving a median sternotomy * Patients previously enrolled and randomised to the CALIPSO trial
Места на провеждане 5
Австралия (1)
Westmead Hospital
Sydney , New South Wales
Канада (1)
Halifax Infirmary
Halifax , Nova Scotia
Malaysia (1)
IJN
Kuala Lumpur
New Zealand (1)
Christchurch Hospital
Christchurch
САЩ (1)
UT Southwestern Medical Centre
Dallas , Texas
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
07.02.2023
Крайна дата
01.06.2028
Регистрационен номер
NCT05447559
Източник
anzctr
Запитване за медицински туризъм

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