Optimization of Perioperative Antibiotic Prophylaxis in Patients Allergic to Beta-lactams in the Orthopedic Surgery and Trauma Departments (ORTHO-PEN)

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: Beta Lactam Adverse Reaction

Study type: Observational

Funder types: Other

Identifiers

NCT07342647

9812

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.