Broad-spectrum antibiotic prophylaxis in tumor and infectious diseases in orthopedic surgery - the prospective randomized, microbiologist-blinded, stratified superiority study - BAPTIST study
Zusammenfassung der Studie
Perioperative antibiotic prophylaxis in orthopedic surgery is evidence-based. While the duration varies worldwide from one to three doses, the choice of prophylactic agents is undisputed. Worldwide, surgeons use first or second generation cephalosporins (or in some cases vancomycin). However, there are certain clinical situations with a high risk of antibiotic-resistant surgical site infections (SSI), regardless of the duration of prophylaxis administered. These resistant SSIs occur in contaminated wounds or during surgical procedures under current therapeutic antibiotics and are based on a "selection" by the antibiotics used for therapy or prophylaxis.
(BASEC)
Untersuchte Intervention
We will make a random selection of the surgical procedures defined by the inclusion criteria in a prospective alternating scheme (1:1) according to the planned timings in the operating rooms. The anesthetists (or the nurses on the wards) administer the standard prophylaxis (or the therapeutic antibiotics), or additionally the broad-spectrum prophylaxis regimen with a dose of vancomycin and gentamicin. In case of clinical suspicion of infection or massive contamination, the surgeons will take at least three microbiological intraoperative tissue samples. Each surgical procedure counts as one intraoperative event. If a patient is debrided multiple times, they may receive a different prophylaxis regimen for each procedure. After the prophylactic treatment, physicians are free to continue with targeted or empirical therapeutic antibiotic therapy. The antibiotic therapy itself is not an objective of this current study.
(BASEC)
Untersuchte Krankheit(en)
Comparison of different antibiotic prophylaxes/therapies in different orthopedic/tumor surgical procedures (e.g., spine, technical orthopedics, infectious diseases...).
(BASEC)
1) Surgeries under current or recently completed antibiotic therapy (antibiotic-free period <14 days and for more than 4 days) 2) Surgeries for open fractures; including 2nd and 3rd visits 3) Potentially contaminated wound revision in the operating room 4) Orthopedic tumor surgeries (oncological) with prior radiotherapy and/or bone involvement 5) Spine surgeries with ASA score ≥ 3 points, sacral involvement and/or revision surgeries 6) Known skin colonization with multidrug-resistant Gram-negative bacteria defined by infection control during surgery (BASEC)
Ausschlusskriterien
1) Surgery without intraoperative microbiological samples 2) Allergy or severe intolerance to vancomycin and/or gentamicin 3) Anticipated clinical follow-up of less than 6 weeks after inclusion 4) Pregnant or breastfeeding women 5) Known transmission of resistant Gram-negative bacteria only in urine or anal area (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Prof. Dr. med. Ilker Uçkay Head Infectiology Balgrist University Hospital Forchstrasse 340 8008 Zürich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Ilker Uckay
+41 044 386 73 05
ilker.uckay@clutterbalgrist.chUniversitätsklinik Balgrist
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
12.07.2022
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Broad-spectrum Antibiotic Prophylaxis in Tumour and Infected Orthopaedic Surgery - the prospective-randomized, microbiologist-blinded, stratified, supe-riority Trials - BAPTIST trials (BASEC)
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