Broad-spectrum antibiotic prophylaxis in tumor and infectious diseases in orthopedic surgery - the prospective randomized, microbiologist-blinded, stratified superiority study - BAPTIST study
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Prof. Dr. med. Ilker Uçkay Head Infectiology Balgrist University Hospital Forchstrasse 340 8008 Zürich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Ilker Uckay
+41 044 386 73 05
ilker.uckay@clutterbalgrist.chUniversitätsklinik Balgrist
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
12.07.2022
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Broad-spectrum Antibiotic Prophylaxis in Tumour and Infected Orthopaedic Surgery - the prospective-randomized, microbiologist-blinded, stratified, supe-riority Trials - BAPTIST trials (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
non disponibile
Disegno dello studio
non disponibile
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile