Prospective Randomized Double Blind, Placebo-Controlled Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection on 30 Day Recurrence Rates.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Recurrence Rates of Abscesses
研究概览
简要总结
Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess.
详细描述
All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients age 18-65 who present to the emergency department with a skin abscess that requires incision and drainage.
排除标准
- •Patients with diabetes, HIV, cancer or other immunocompromised patients.
- •Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.
- •Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.
- •Patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
- •Finally, patients with sulfa allergy will be excluded.
研究组 & 干预措施
Bactrim DS
Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days
干预措施: Trim/ Sulfa DS (Drug)
matched placebo
matched placebo 2 pills orally (PO) twice a day (BID) x 7 days
干预措施: placebo (Drug)
结局指标
主要结局
Recurrence Rates of Abscesses
时间窗: 30 days after incision and drainage
Number of patient with a new abscess in same or different location as previous lesion
次要结局
未报告次要终点
研究者
Gillian Schmitz
Emergency Physician
59th Medical Wing