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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07342647

Acronym

ORTHO-PEN

Enrollment

Registered

2026-01-15

Start date

2025-07-11

Completion date

2026-07-11

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta Lactam Adverse Reaction

Keywords

Beta Lactam Adverse Reaction, Antibiotic Prophylaxis, Beta-Lactamines, Orthopedic Surgery

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Evolution of the rate of compliant prescriptions for intraoperative antibiotic prophylaxis in patients declared allergic to beta-lactams	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.

Countries

France

Contacts

Primary ContactAurélie REITER-SCHATZ, MD

aurelie.reiter-schatz@chru-strasbourg.fr33 3 68 76 50 14

Outcome results