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Clinical Trials/NCT07342647
NCT07342647
Recruiting
Not Applicable

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 site in 1 country50 target enrollmentStarted: July 11, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
University Hospital, Strasbourg, France
Enrollment
50
Locations
1
Primary Endpoint
Evolution of the rate of compliant prescriptions for intraoperative antibiotic prophylaxis in patients declared allergic to beta-lactams

Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Strasbourg, France
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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