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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
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.
Prince of Wales Hospital
Shatin, Hong Kong
RECRUITINGUse of first-line antibiotic
The primary endpoint is use of first-line antibiotic for surgical prophylaxis according to local guideline .
Time frame: from the date of randomization up to 3 months
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.
Time frame: 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.
Time frame: 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).
Time frame: from the date of randomization up to 3 months
Length of stay
Length of hospital stay in this episode
Time frame: 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
Time frame: form the date of randomization up to hospital discharge and from the date of randomization up to 3 months
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