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Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

Study acronym: BAPTIST
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 2, 2024 (before its estimated December 12, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Primary completion date: Dec 31, 2024 to Dec 12, 2024
    • Study completion date: Dec 31, 2025 to Dec 12, 2025
    v5
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Notable Enrollment target: 414 to 1100
    • Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05502380
Lead Sponsor Balgrist University Hospital
Conditions
(from sponsor)
Surgical Site Infection, Microbial Colonization, Antibiotic Resistant Infection
Related terms Communicable Diseases, Surgical Wound Infection
Enrollment 1,100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov