Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06067919
Status:
RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-09-28
Brief Title:
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
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROPHYLAL
Brief 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None