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Assessment of the Applicability and Acceptability of an Algorithm to Guide the Prescription of 1st and 2nd Generation Cephalosporins as Part of Intraoperative Antibiotic Prophylaxis in Patients With a Declared Allergy to Penicillin

NCT06067919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2025-08-24

No results posted yet for this study

Summary

According to the Centers for Disease Control and Prevention (CDC), a surgical site infection (SSI) is an infection that occurs after surgery at the site where the surgery was performed. The prevalence of SSIs is difficult to obtain and is probably underestimated, as many SSIs occur after the patient has been discharged from hospital and are not taken into account. SSIs are responsible for an increase in length of stay, mortality and costs. Their prevention is therefore essential in the operating theater, and has been the subject of recommendations recently updated by the CDC. The first line of prevention is the administration of prophylaxis antibiotic adapted to the surgical procedure, administered within a specific timeframe in order to achieve an effective bactericidal concentration in the tissues at the time of the surgical incision. In France, in the United States and for the WHO, the recommended first line of antibiotic prophylaxis is most often an agent from the beta-lactam family, a penicillin or a cephalosporin, with the exception of ophthalmological surgery. No strategy is described for the management of patients with a reported allergy to penicillin, apart from the recommendation of therapeutic alternatives.

The use of a decision-making strategy in the operating theater for patients with a reported allergy to penicillin therefore appears necessary and is recommended by experts. In the intraoperative context, the application of a strategy would make it possible to guide the use of cephalosporins, without removing the "penicillin allergy" label from the patient, but by proposing an alternative via the use of a cephalosporin depending on the probability of the risk of a real allergy to penicillin, according to the description of the former reaction.

Conditions

  • Adult Patients Who Declare an Allergy to Penicillin During Anaesthetic Consultation Without Any Allergy Work up That Could Confirm This Declaration
  • Good Comprehension of French Language

Interventions

OTHER

decision tree for the choice of intraoperative antibiotic prophylaxis

Presentation of a decision tree to anaesthetists to guide the choice of intraoperative antibiotic prophylaxis

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Mouna Ben Rehouma · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2024-12-30
Completion
2025-05-20

Countries

  • France

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 NCT06067919 on ClinicalTrials.gov