Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis

Not Applicable

Recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Detailed penicillin allergy evaluation during pre-operative care	Detailed penicillin allergy evaluation	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.

Primary Outcome Measures

Name	Time	Method
Use of first-line antibiotic	from the date of randomization up to 3 months	The primary endpoint is use of first-line antibiotic for surgical prophylaxis according to local guideline .

Secondary Outcome Measures

Name	Time	Method
Antibiotic related adverse events	from the date of randomization up to 3 months	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.
Surgical site infection	from the date of randomization up to 30 days	SSI is defined as an infection that occurs within 30 days after surgery in the part of the body where the surgery took place.
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	All-cause mortality during hospital stay and within 3 months
Colonization of multi-drug resistant organisms	from the date of randomization up to 3 months	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).
Length of stay	from the date of hospital admission up to hospital discharge or one year whichever earlier	Length of hospital stay in this episode

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