Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis

NCT05823155 | Unknown

• 1 other identifier: Penicillin allergy Protocol V1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Penicillin Allergy; Surgical Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Use of first-line antibiotic

  The primary endpoint is use of first-line antibiotic for surgical prophylaxis according to local guideline .

  from the date of randomization up to 3 months

Secondary Outcomes (5)

• Antibiotic related adverse events

  from the date of randomization up to 3 months

• Surgical site infection

  from the date of randomization up to 30 days

• Colonization of multi-drug resistant organisms

  from the date of randomization up to 3 months

• Length of stay

  from the date of hospital admission up to hospital discharge or one year whichever earlier

• All-cause mortality during hospital stay

  form the date of randomization up to hospital discharge and from the date of randomization up to 3 months

Study Arms (2)

Detailed penicillin allergy evaluation during pre-operative care

EXPERIMENTAL

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.

Procedure: Detailed penicillin allergy evaluation

Standard pre-operative care

NO INTERVENTION

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

Interventions

Detailed penicillin allergy evaluation PROCEDURE

The intervention group will undergo a detailed penicillin allergy evaluation performed by an Infectious Diseases specialist. Components of penicillin allergy evaluation include verification of allergy history (drug involved including dose and route of administration, exact manifestation of labelled allergy and timing of occurrence after use of alleged culprit, history of skin tests or in vitro testing for diagnosis of allergy, subsequent rechallenge of the same or similar antibiotics), followed by skin test (prick test and intradermal test) and oral provocation test as appropriate.

Detailed penicillin allergy evaluation during pre-operative care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Central Study Contacts

Catherine Cheung

CONTACT

+852 350503376; catherinecheung@cuhk.edu.hk

Grace Lui

CONTACT

+852 3505 1716; gracelui@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: April 21, 2023
• Study Start: April 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

HK (1)