Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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age 18 years or above
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planned for clean or clean-contaminated elective surgeries
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labelled allergy to penicillin group antibiotics on electronic patient record (ePR)
Exclusion Criteria:
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multiple antibiotic allergy
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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
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on systemic immunosuppressants
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pregnancy
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active or uncontrolled chronic urticaria
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mentally incompetent for informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prince of Wales Hospital | Shatin | Hong Kong |
Sponsors and Collaborators
- Chinese University of Hong Kong
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Penicillin allergy Protocol V1