The LOOP Trial: A Study Comparing the Use of the LOOP Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses in a Level I Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 主要终点
- Treatment Failure
研究概览
简要总结
This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Two methods of drainage were compared: 1) the LOOP technique or 2) standard packing technique.
详细描述
This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Patients were excluded if the abscess was on the hand, foot, or face or if it required admission or operative intervention. Patients were followed over 10 days to determine the primary outcome of treatment failure defined by need for admission, IV antibiotics, or repeat drainage within 10-day follow-up. The secondary outcomes included ease of procedure, ease of care, pain after insertion and patient satisfaction using a 10-point numeric rating.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subcutaneous skin abscesses necessitating drainage
排除标准
- •Abscess was on the hand, foot, or face
- •Requiring admission or operative intervention
研究组 & 干预措施
LOOP Technique
Placement of subcutaneous loop drain
干预措施: LOOP Technique (Procedure)
Incision and Drainage
Standard Incision and Drainage Technique
干预措施: Standard incision and drainage (Procedure)
结局指标
主要结局
Treatment Failure
时间窗: 10 Days
Need for admission, IV antibiotics, or repeat drainage within 10-day follow-up derived from descriptive nature
次要结局
- Procedure Pain(At time of procedure)
- Ease of procedure(At time of procedure)
- Ease of care(During 10 days)
- Pain on follow-up(10 days)
- Patient satisfaction(During 10 days)
研究者
Jay Ladde
Associate Program Director
Orlando Regional Medical Center
