Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery (NCT05502380) | Clinical Trial Compass
RecruitingPhase 3
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
Switzerland1,100 participantsStarted 2022-09-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Surgical Site Infections (SSI) at 6 weeks for surgeries without implant; and 1 year for surgeries with implant
Timeframe: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery