Is Loop Drainage of a Cutaneous Abscess in the Emergency Department as Effective as Incision and Drainage With Packing?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 2
- 主要终点
- Abscess Resolution
研究概览
简要总结
Management of abscesses traditionally involves incision and drainage (I&D). Abscesses are frequently are "packed" or stented open with the presence of a wick, and traditional care requires re-visits every 2-3 days to have the packing removed and replaced, until finally the abscess cavity has closed, usually 1-2 weeks after initial presentation.
Recently there have been attempts to employ less invasive techniques for abscess management. One novel technique, "loop drainage", has been reported in case reports/case series for management of a variety of types of abscesses in the surgical subspecialty literature.
We propose to conduct a randomized prospective study comparing the efficacy of the loop drainage technique with the traditional incision and drainage technique of abscess management.
Patients presenting to the main or urgent care areas of the Emergency Department at Boston Medical Center for treatment of an abscess will be considered for enrollment as potential subjects. After the treating clinician identifies the patient as an appropriate subject, a Research Associate (RA) will approach the patient and obtain written informed consent to enroll in the study. The subject will then be randomized to the management arm of either loop drainage or traditional I&D. The clinician will fill out a data sheet describing the abscess characteristics, and then perform either loop drainage or incision and drainage, depending on randomization and the subject will fill out a satisfaction survey. Fourteen days after initial visit, subjects will return for follow-up. The subject will fill out a satisfaction survey, and a study investigator blinded to the treatment group will assess the subject for abscess resolution, cosmetic outcome, number of follow-up visits, and complications.
The study investigators will then compare outcomes between the two study groups.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient over 18 years of age
- •Presenting to the Boston Medical Center main Emergency Department or Urgent Care area for initial treatment of a skin abscess
- •English speaking
- •Able to provide written informed consent
- •Willing to return in 14 days for follow-up visit
- •Able to give a telephone number for follow-up contact
排除标准
- •Previously treated for this abscess
- •Altered mental status
- •Patients with active psychiatric issues that preclude their ability to provide informed consent
- •Previously enrolled in the study
- •Abscess is not amenable to treatment by an Emergency Physician in the Emergency Department
- •Abscess is post-operative or post-procedure
- •Clinician determines abscess is not amenable to drainage by particular method
- •Abscess is too small for packing or loop
- •Need for hospital admission
结局指标
主要结局
Abscess Resolution
时间窗: 14 days
If no, which sign is present (check all that apply): 1. Fluctuance 2. Drainage 3. Induration 4. Warmth 5. Tenderness 6. Other \_\_\_\_\_\_\_\_\_\_
次要结局
- Number of Complications(14 days)
- Patient Satisfaction Immediately After Procedure(Time 0)
- Patient Satisfaction after Abscess Resolution(14 Days)
- Number of Follow Up Visits(14 days)
- Cosmetic Outcome(14 days)
研究者
Elissa Schechter-Perkins
Assistant Professor of Emergency Medicine
Boston Medical Center