Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ito Hospital
- 入组人数
- 2,164
- 试验地点
- 1
- 主要终点
- Surgical site infections after thyroid and parathyroid surgery
研究概览
简要总结
The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean neck surgery associated with thyroid and parathyroid disease.
详细描述
Between November 2010 and April 2012, 2164 consecutive patients who agreed to attend the randomized control study were enrolled. All the participants received surgery for thyroid and parathyroid disease at Ito Hospital and randomized in three groups; Group A (n=541): operation with AMP (PIPC, piperacillin sodium), Group B (n=541): operation with AMP (CEZ, cefazolin sodium), and Group C (n=1082): operation without AMP.
Exclusion criteria
- Patients who did not agree to attend the randomized control study.
- Patients who received the operation including mediastinum with sternotomy.
- Patients who received the operation including additional resection of trachea, esophagus and larynx.
- Patients who received the re-operation for post-operative bleedings.
- Patients who had known allergy to cephem or penicillin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between November 2010 and April 2012, 2164 consecutive patients who agreed to attend the randomized control study were enrolled. All the participants received surgery for thyroid and parathyroid disease at Ito Hospital.
排除标准
- •Patients who did not agree to attend the randomized control study.
- •Patients who received the operation including mediastinum with sternotomy.
- •Patients who received the operation including additional resection of trachea, esophagus and larynx.
- •Patients who received the re-operation for post-operative bleedings.
- •Patients who had known allergy to cephem or penicillin.
研究组 & 干预措施
Group A (intervention PIPC)
Patients in group A (intervention PIPC) were given AMP of 2g PIPC intravenously just after intubation. If the operation time was longer than 3 hours, additional infusion of same dose PIPC was done. After coming back to the patients' own room, one more infusion of same dose of same drug was done.
干预措施: PIPC piperacillin sodium (Drug)
Group B (intervention CEZ)
Patients in Group B (intervention CEZ) were given AMP of 1g CEZ intravenously just after intubation. If the operation time was longer than 3 hours, additional infusion of same dose CEZ was done. After coming back to the patients' own room, one more infusion of same dose of same drug was done.
干预措施: CEZ, cefazolin sodium (Drug)
结局指标
主要结局
Surgical site infections after thyroid and parathyroid surgery
时间窗: 1 month after operation
Surgical site infection was defined as patients who are necessary to receive the treatment such as surgical drainage or antibiotic medication. When the patients receive the surgical drainage, microbial culture was performed.
次要结局
- Side effect of the drug for Antimicrobial prophylaxis(4 days after operation)