Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis

Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Penicillin Allergy; Surgical Prophylaxis
• Intervention / Treatment: Procedure: Detailed penicillin allergy evaluation

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Cheung; Phone Number: +852 350503376; Email: catherinecheung@cuhk.edu.hk
• Study Contact Backup: Name: Grace Lui; Phone Number: +852 3505 1716; Email: gracelui@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Detailed penicillin allergy evaluation during pre-operative care; 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; 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.
No Intervention: Standard pre-operative care; This group will receive standard perioperative care. The choice of antibiotics during the perioperative period will be decided by surgical team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic related adverse events	Antibiotic related adverse events include: 1) any new symptoms reported by patients, or 2) abnormalities in blood tests that are compatible with known side effects of antibiotics given and that occurred after initiation of antibiotics.	from the date of randomization up to 3 months
Surgical site infection	SSI is defined as an infection that occurs within 30 days after surgery in the part of the body where the surgery took place.	from the date of randomization up to 30 days
Colonization of multi-drug resistant organisms	Multi-drug resistant organisms include methicillin resistant Staphylococcus aureus (MRSA), extended spectrum beta-lactamase (ESBL) producing Enterobacterales, carbapenem resistant Enterobacterales (CRE), multi-drug resistant Acinetobacter species (MDRA), multi-drug resistant Pseudomonas aeruginosa (MRPA), and vancomycin resistant Enterococci (VRE).	from the date of randomization up to 3 months
Length of stay	Length of hospital stay in this episode	from the date of hospital admission up to hospital discharge or one year whichever earlier
All-cause mortality during hospital stay	All-cause mortality during hospital stay and within 3 months	form the date of randomization up to hospital discharge and from the date of randomization up to 3 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity; Anti-Infective Agents; Anti-Bacterial Agents; Penicillins
• Other Study ID Numbers: Penicillin allergy Protocol V1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No