Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,278
- 试验地点
- 6
- 主要终点
- Number of post-hysterectomy episodes with deep infections
研究概览
简要总结
During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. By reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. This study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. In addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
single blinded - the placebo tablets slightly differ from the azithromycin tablets, therefore they are sealed in package which is given straight to the participant
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing hysterectomy for benign indication in University Hospitals (Helsinki University Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital and Kuopio University Hospital) who have not any contraindications for azithromycin or cefuroxime.
排除标准
- •Inability to understand the study protocol.
- •Allergy for either cefuroxime or azithromycin.
- •Congenital or acquired prolonged Q-T-corrected interval. All the participants will be asked about arrhythmias and whether they have congenital arrhythmias in the family,
- •Electrocardiogram will be checked for all the participants.
- •Use of medicines that may prolong Q-T-corrected interval (class Ia arrhythmia medications, quinidine, procainamide, and class III arrhythmia medications dofetilide, amiodarone and sotalol).
- •Use of selective serotonin reuptake inhibitor medication and prolonged Q-T-corrected interval.
研究组 & 干预措施
Azithromycin + Cefuroxime
Changed with renewed study permissions:
These patients will receive Azithromycin 500 mg (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more) in the operating theatre before the incision.
The previous description:
These patients will receive Azithromycin 500 mg (2 tablets) per orally in the evening before the operation and single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision.
干预措施: Azithromycin Pill + Cefuroxime (Drug)
Placebo + Cefuroxime
Changed with new study permissions:
These patients will receive placebo (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more)in the operating theatre before the incision.
The previous description:
These patients will receive placebo (2 tablets) per orally in the evening before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision.
干预措施: Placebo + Cefuroxime (Drug)
结局指标
主要结局
Number of post-hysterectomy episodes with deep infections
时间窗: Deep infections that occur between the first and 30th postoperative day after hysterectomy
Number of deep wound and pelvic organ infection episodes reported by patients and doctors
次要结局
- Number of other post-hysterectomy infections or fever episodes(Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.)
研究者
Päivi Rahkola-Soisalo
Adjuct professor, M.D.
Helsinki University Central Hospital