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临床试验/NCT07342647
NCT07342647招募中不适用

Optimization of Perioperative Antibiotic Prophylaxis in Patients Allergic to Beta-lactams in the Orthopedic Surgery and Trauma Departments of the Strasbourg University Hospitals

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Evolution of the rate of compliant prescriptions for intraoperative antibiotic prophylaxis in patients declared allergic to beta-lactams

研究概览

简要总结

When surgery is required, a consultation with an anesthesiologist is mandatory. This preoperative consultation allows for the selection of the appropriate antibiotic prophylaxis tailored to the patient and the type of procedure. The French Society of Anesthesiology and Intensive Care (SFAR) has published recommendations on antibiotic prophylaxis for different types of surgery. During this consultation, several topics are addressed, including drug allergies. This topic plays a central role in the choice of antibiotic prophylaxis.

Ten percent of the population is labeled as allergic to beta-lactams, but only 1% actually are. Diagnosis is difficult and requires specialized teams. In response to the significant increase in patients labeled as allergic, and consequently the rise in requests to specialists, a scoring system has been developed for use by all physicians: the PEN FAST score. This score stratifies the risk of a true penicillin allergy and guides the selection of delabeling strategies. The test aims to eliminate the need for skin prick tests and allows for the direct reintroduction of the drug when the score is below 3. It is based on five questions. Each question is assigned a point value, which is used to calculate a score and thus an estimated risk.

The primary objective of this study is to improve the management of patients allergic to beta-lactams in orthopedic and trauma surgery by ensuring optimal and appropriate intraoperative antibiotic prophylaxis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient (≥ 18 years old)
  • Patient operated on at Strasbourg University Hospital between January 1, 2023, and December 31, 2023, for total knee, shoulder, or hip replacement.
  • Patients who underwent surgery at Strasbourg University Hospital between March 1, 2025, and July 31, 2025, involving surgery requiring intraoperative antibiotic prophylaxis.

排除标准

  • Patients with a surgical indication without the use of implants.
  • Patients with a surgical indication without antibiotic prophylaxis.

结局指标

主要结局

Evolution of the rate of compliant prescriptions for intraoperative antibiotic prophylaxis in patients declared allergic to beta-lactams

时间窗: Up to 12 months

Rate trend: Trend refers to how this rate changes over time. We want to see if: * The rate increases: therefore, there are more correct prescriptions * The rate remains stable * The rate decreases: therefore, there are more prescription errors.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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