Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Balgrist University Hospital
• Treatments: Anti-Bacterial Agents

Criteria

Inclusion Criteria

• 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

• Tumor (oncologic) surgery (if prior radiotherapy and/or bone involvement)

• Spine surgery with ASA-Score >= 3 points, sacral involvement, or re-vision surgery

• Known skin colonization with multidrug-resistant Gram-negative bacteria

Exclusion Criteria:

• 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

• Pregnant or breastfeeding women

• Known carriage of multiresistant Gram-negative bacteria in the urine or anal region