Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBalgrist University Hospital
About this trial
The perioperative antibiotic prophylaxis is evidence-based in orthopedic surgery. While its duration ranges from a single dose to three doses throughout the world, the choice of the prophylactic agents is undisputed. Worldwide, the surgeons use 1st or 2nd-generation cephalosporins (or vancomycin in some cases).
However, there are particular clinical situation with a high risk of antibiotic-resistant surgical site infections (SSI); independently of the duration of adminis-tered prophylaxis. These resistant SSI's occur in contaminated wounds, or during surgery under current therapeutic antibiotics, and base on "selection" by antibiotics used for therapy or for prophylaxis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Surgery under current or recent therapeutic antibiotics (antibiotic-free window <14 days and past antibiotic prescription >4 days)
Surgery for open fractures and wounds; including 2nd and 3rd looks
Potentially contaminated wound revision in the operating theatre
Disqualifiers
Inability to understand the study procedure for linguistic or cognitive rea-sons
Surgery without intraoperative microbiological samples
Allergy or major intolerance to vancomycin and/or gentamicin
Anticipated clinical follow-up of less than 6 weeks after inclusion
Trial design
Design model
Parallel
Treatments tested in this trial
Standard antibiotic prophylaxis
DrugOne to three intravenous doses of cefuroxime 1.5 g intravenously; or 3g if obesity; or vancomycin 1 g or clindamycin 600 mg; if allergy. Continuation of eventual current therapeutic antibiotc regimens for any infection
Treatment groups
1,100 Participants
are divided into 2 treatment groupsGroup A: Standard prophylaxis armActive comparator 1 intervention
Group B: Innovative prophylaxis armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Surgical Site Infections (SSI) at 6 weeks for surgeries without implant; and 1 year for surgeries with implant
Assessment of SSI at the clinical controls according to clinical criteria in the literature (pus, discharge, pain, inflammation, several deep tissue microbiological cultures
Time frame
6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgerySecondary outcomes
1
Proportion of antibiotic-resistant pathogens in the deep surgical site of the study patients; in relation to the prior antibiotic prophylaxis or the current therapeu-tic antibiotic therapy
Assessments of antibiotic resistance of pathogens according to standard susceptibilty testing in the Microbiological Laboratory
Time frame
6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery2
Incidence of revision surgery for non-infections reasons within 6 weeks
Unplanned revision surgery in the operating theatre for any reasons
Time frame
6 weeks postoperatively3
Proportion of the change of antibiotic therapy based on intraoperative findings
Asssesment in the medical files. Have therapeutic antibiotics been changed according to new intraoperative bacterial culture findings
Time frame
6 weeks postoperatively4
Incidence of dverse events and global costs of therapeutic antibiotics (if any)
If there is therapeutic antibiotc treatment necessary, the investigators assess the drugs, the adverse events and the global costs related to the antibiotc treatment. The costs are the global (overall) hospitalizations costs in Swiss Francs.
Time frame
6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgerySponsors and contacts
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Source ClinicalTrials.gov