Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis

Study Overview
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Brief Summary
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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.

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

Conditions
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Penicillin Allergy, Surgical Prophylaxis

Intervention / Treatment
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* Procedure: Detailed penicillin allergy evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Detailed penicillin allergy evaluation during pre-operative care<br>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<br>* 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.<br>|
| No Intervention: Standard pre-operative care<br>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?
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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 |