Penicillin Allergy, Surgical Prophylaxis
Conditions
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.
Interventions
PROCEDUREDetailed 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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hong Kong
Contacts
Primary ContactCatherine Cheung
Backup ContactGrace Lui
Outcome results
None listed