A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Skin Abscess Resolution
研究概览
简要总结
The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.
详细描述
This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound identified skin abscesses who were not on antibiotics. Patients were block randomized to receive placebo or trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3 days & a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution with development of new lesion (furuncle, carbuncle or abscess) at a different location. Compliance was evaluated by the return of the study medication or by patient report.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-toxic patients
- •immunocompetent patients
- •3 months to 18 years old
- •English-speaking patients
- •skin abscesses
- •not on antibiotics
排除标准
- •toxic patients
- •immunocompromising co-morbidities
- •less than 3 months old or older than 18 years of age
- •non-english speaking
- •on antibiotics
研究组 & 干预措施
placebo group
Maalox and bitter mixture
干预措施: Placebo group (Drug)
antibiotic group
Trimethoprim-sulfamethoxazole suspension
干预措施: Trimethoprim-sulfamethoxazole (Drug)
结局指标
主要结局
Skin Abscess Resolution
时间窗: 10-14 days
次要结局
- New Lesion Development and Spread of Skin Abscesses (on Subject)(10-14 days and 3 month)
