Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Use of first-line antibiotic
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years or above
- •planned for clean or clean-contaminated elective surgeries
- •labelled allergy to penicillin group antibiotics on electronic patient record (ePR)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Detailed penicillin allergy evaluation (Procedure)
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.
结局指标
主要结局
Use of first-line antibiotic
时间窗: 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 .
次要结局
- 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)
- Colonization of multi-drug resistant organisms(from the date of randomization up to 3 months)
- Length of stay(from the date of hospital admission up to hospital discharge or one year whichever earlier)
- Antibiotic related adverse events(from the date of randomization up to 3 months)
- Surgical site infection(from the date of randomization up to 30 days)
研究者
Grace Lui
Clinical Associate Professor
Chinese University of Hong Kong