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Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

RECRUITINGPhase 3Sponsored by Balgrist University Hospital
Actively Recruiting
PhasePhase 3
SponsorBalgrist University Hospital
Started2022-09-15
Est. completion2024-12-12
Eligibility
Age18 Years+
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

Antibiotic Resistant InfectionCancerMicrobial ColonizationSurgical Site Infection

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