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Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

NCT05502380 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2024-12-02

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection
  • Microbial Colonization
  • Antibiotic Resistant Infection

Interventions

DRUG

Standard antibiotic prophylaxis

One to three intravenous doses of cefuroxime 1.5 g intravenously; or 3g if obesity; or vancomycin 1 g or clindamycin 600 mg; if allergy. Continuation of eventual current therapeutic antibiotc regimens for any infection

Sponsors & Collaborators

  • Balgrist University Hospital

    lead OTHER

Principal Investigators

  • Ilker Uçkay, Professor · Balgrist University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2024-12-12
Completion
2025-12-12

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05502380 on ClinicalTrials.gov