Broad-spectrum Antibiotic Use to Prevent Infection in Tumor and Infected Orthopedic Surgery A Phase 3 Randomized Study Comparing Standard and Additional Vancomycin-Gentamicin Prophylaxis

What this Trial Is About

Researchers are evaluating the use of broad-spectrum antibiotic prophylaxis in specific orthopedic surgeries, such as tumor surgeries, infected wound debridements, and open fractures, where there is a high risk of surgical site infections SSIs caused by antibiotic-resistant bacteria. The study explores whether adding vancomycin and gentamicin to standard prophylaxis can better prevent infections, especially in cases involving resistant pathogens or ongoing antibiotic treatments. This phase 3 trial focuses on improving infection control in these high-risk surgical situations. Participants in the trial are randomly assigned to receive either standard antibiotic prophylaxis, which includes one to three doses of cefuroxime or alternatives like vancomycin or clindamycin in case of allergies, or an additional single-shot broad-spectrum prophylaxis with vancomycin and gentamicin given intravenously before surgery. The study allows for continued therapeutic antibiotic use if applicable and includes various surgical conditions such as tumor surgery, spine surgery with specific risk factors, and contaminated wounds. Each surgery is treated as a separate event, and patients undergoing multiple surgeries may receive different prophylaxis each time. During the study, participants will have daily visits starting with enrollment on Day 1, followed by an end-of-treatment visit around Day 14, and a test-of-cure surgical control visit around Day 42. A telephone follow-up occurs after one year for implant-related surgeries. Researchers will monitor surgical site infections at 6 weeks or 1 year depending on implant use, track antibiotic-resistant pathogens, assess changes in antibiotic therapies, record adverse events, and evaluate infection rates and bacterial colonization. The study aims to provide detailed insights into infection prevention and antimicrobial resistance in orthopedic surgery.

Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery