Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis

Not Applicable

Recruiting

• Conditions: Penicillin Allergy; Surgical Prophylaxis

• Registration Number: NCT05823155
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-11
• Status Verified: 2023-04
• Study Start: 2023-04-01
• Study First Submitted QC: 2023-04-19
• Last Update Submitted: 2023-04-19
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
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.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong