NCT05502380Recruiting
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- Balgrist University Hospital(Other)
- Protocol no.
- BASEC 2022-00800
- Conditions
- Surgical Site Infection, Microbial Colonization, Antibiotic Resistant Infection
- Interventions
- Drug
Treatments studied
- Standard antibiotic prophylaxis
Locations · 1
- Zurich, SwitzerlandBalgrist University HospitalRecruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: December 2, 2024).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.