Bichat hospital
Paris, France
NCT Number: NCT06067919
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Presentation of a decision tree to anaesthetists to guide the choice of intraoperative antibiotic prophylaxis
Time frame: surgery day
Rate of prescription of 1st cephalosporins for intraoperative antibiotic prophylaxis.
Time frame: surgery day
Rate of prescription of 2nd generation cephalosporins for intraoperative antibiotic prophylaxis.
Time frame: 30 days after surgery
number of surgical site infections (SSI)
Time frame: 30 days after surgery
number of new surgery due to SSI
Time frame: surgery day
Number of intraoperative hypersensitivity reactions attributable to antibiotic prophylaxis
Assistance Publique - Hôpitaux de Paris
Other
Acronym: PROPHYLAL
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