Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- postoperative infection
研究概览
简要总结
The primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.
详细描述
Participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. Short- and intermediate-term results will be published after participants complete 6 months and 5 years of follow-up, respectively.
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
- — 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •mid-to-distal shaft hypospadias
- •single-stage hypospadias repair
- •length of urethral repair (urethroplasty) less than or equal to 20 mm
- •placement of an open-drainage urethral stent at the time of hypospadias repair, with intended duration of stenting for 5-10 days post-operatively
排除标准
- •previous hypospadias repair
- •prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole
- •cross-reactivity of an existing medication with trimethoprim-sulfamethoxazole
- •any patient condition with elevated risk of infection or adverse outcome from potential infection (e.g., HIV/AIDS, poorly controlled diabetes mellitus or other immunocompromising conditions, congenital heart disease)
- •use of antibiotics within seven days prior to hypospadias repair
- •foreskin reconstruction at the time of hypospadias repair
- •prescription of oral antibiotics other than Study Medication at the time of hypospadias repair
研究组 & 干预措施
Antibiotics
trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days
干预措施: trimethoprim-sulfamethoxazole (Drug)
Placebo
placebo oral suspension, 0.5 mL/kg twice daily for 10 days
干预措施: placebo (Other)
结局指标
主要结局
postoperative infection
时间窗: up to 30 days
Urinary tract infection; cellulitis/wound infection
wound-healing complications
时间窗: up to 5 years
meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum
次要结局
- adverse drug reaction(up to 14 days)
- C. difficile colitis(up to 6 months)
研究者
Earl Y Cheng, MD
Head, Division of Urology
Ann & Robert H Lurie Children's Hospital of Chicago