Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Penicillin Allergy; Surgical Prophylaxis

Treatments: Procedure: Detailed penicillin allergy evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT05823155

Penicillin allergy Protocol V1

Details and patient eligibility

About

Use of first-line pre-operative antibiotic prophylaxis is the most effective measure to optimize perioperative outcomes. However, this is often not achieved due to unsubstantiated penicillin allergy labels. Penicillin allergy evaluation, when incorporated into routine pre-operative assessment, is potentially effective in optimizing choice of surgical prophylaxis. Despite the encouraging data mentioned above, there is a lack of randomized trials or local data to support this practice.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18 years or above
• planned for clean or clean-contaminated elective surgeries
• labelled allergy to penicillin group antibiotics on electronic patient record (ePR)

Exclusion criteria

• multiple antibiotic allergy
• history of severe cutaneous adverse reactions or other severe non-IgE-mediated hypersensitivity (e.g. haemolytic anaemia, organ dysfunction, serum sickness) due to beta-lactam antibiotics
• on systemic immunosuppressants
• pregnancy
• active or uncontrolled chronic urticaria
• mentally incompetent for informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Detailed penicillin allergy evaluation during pre-operative care

Experimental group

Description:

This group will undergo a detailed penicillin allergy evaluation performed by an Infectious Diseases specialist. Patients with negative result in skin test and oral provocation test will have their prior labelled penicillin allergy removed from electronic health record, and an additional entry documenting the negative allergy evaluation will be added. A letter signed by an infectious disease specialist documenting the allergy evaluation results will also be given to patients.

Treatment:

Procedure: Detailed penicillin allergy evaluation

Standard pre-operative care

No Intervention group

Description:

This group will receive standard perioperative care. The choice of antibiotics during the perioperative period will be decided by surgical team.