drugset / Trial / NCT05502380

Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

NCT05502380

Phase 3 Recruiting 1100 enrolled Balgrist University Hospital
RandomizedParallel-groupSingle-blindPrevention

Summary

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.

Timeline

Start
2022-09-15
Primary completion
2024-12-12
Completion
2025-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefuroxime Small molecule 1.5 g Intravenous
Subject Cefuroxime Small molecule 3 g Intravenous
Subject Clindamycin Unknown 600 mg
Subject Gentamicin Small molecule 5 mg/kg Intravenous
Subject Vancomycin Other / unclassified 1 g Intravenous