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Completed

NCT Number: NCT06067919

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bichat hospital

Paris, France

About this study

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.

The main objective is to assess the impact on first and second generation cephalosporins prescription rate of a decision tree designed to guide the prescription of first and second generation cephalosporins in patients with a self-reported allergy to penicillin.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years;
  • Patients with a good French understanding
  • Who declare themselves allergic to penicillin and who have not benefit from an allergy work-up to explore their allergies and possible therapeutic alternatives;
  • Requiring antibiotic prophylaxis with either first or second generation cephalosporins for elective or emergency surgery.

Exclusion criteria

  • Refusal to sign informed consent
  • Patient under legal protection ;
  • Pregnant women;
  • Patient scheduled for surgery requiring first-line antibiotic prophylaxis with an agent other than first and second generation cephalosporins (such as amoxicillin/clavulanate or vancomycin) according to the recommendations of the French Society of Anaesthesia and Intensive Care (SFAR) in one of the investigating centres;
  • Patient declaring an allergy to antibiotics other than penicillins.
  • Not affiliated to a social security scheme

Treatment and study plan

decision tree for the choice of intraoperative antibiotic prophylaxis

Other

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

Primary outcomes

  1. prescription of 1st generation cephalosporins

    Time frame: surgery day

    Rate of prescription of 1st cephalosporins for intraoperative antibiotic prophylaxis.

  2. prescription of 2nd generation cephalosporins

    Time frame: surgery day

    Rate of prescription of 2nd generation cephalosporins for intraoperative antibiotic prophylaxis.

Secondary outcomes

  1. surgical site infections (SSI)

    Time frame: 30 days after surgery

    number of surgical site infections (SSI)

  2. new surgery due to surgical site infections (SSI)

    Time frame: 30 days after surgery

    number of new surgery due to SSI

  3. intraoperative hypersensitivity reactions attributable to antibiotic prophylaxis

    Time frame: surgery day

    Number of intraoperative hypersensitivity reactions attributable to antibiotic prophylaxis

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PROPHYLAL

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 5, 2023
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.