跳至主要内容
临床试验/NCT00679302
NCT00679302已完成4 期

A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics

St. Louis University1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Maalox and bitter mixture

干预措施: Placebo group (Drug)

antibiotic group

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Utility of Trimethoprim-sulfamethoxazole Use in Skin... | 临床试验