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Table 2 Outcome parameters and assessments of both randomized trials

From: Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials

Primary outcome

    - Remission (and inversely deep surgical site infection) at 6 weeks for surgeries without implant and 1 year for surgeries with implant

Secondary outcomes:

    - Risk of (antibiotic-resistant) pathogens in the deep surgical site of the study patients

    - Revision surgery for non-infections reasons within 6 weeks

    - Change of antibiotic therapy for infection, based on intraoperative findings

    - Spectrum and adverse events of therapeutic antibiotic use (if any)

    - Incidence and antibiotic resistance of non-SSI infections within 6 weeks (e.g., urine)

    - Body colonization with multi-resistant bacteria at 4–-6 weeks (if any samples)

  1. Assessment of outcomes: prospective assessment by study team during hospitalization. Retrospective assessment by study nurses and surgeons during the surgical controls after hospitalization. These controls are standard after 6 weeks and 1 year
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Trials

ISSN: 1745-6215