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 range18 Years

SexALL

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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

What they're measuring

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

Trial details

NCT IDNCT05502380

SponsorBalgrist University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-12

Contact for this trial

Ilker Uçkay, Professor

++41 44 386 37 05 ilker.uckay@balgrist.ch