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临床试验/NCT03398746
NCT03398746已完成不适用

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

Orlando Regional Medical Center0 个研究点目标入组 217 人开始时间: 2009年1月22日最近更新:
适应症
干预措施

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

Experimental

Placement of subcutaneous loop drain

干预措施: LOOP Technique (Procedure)

Incision and Drainage

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jay Ladde

Associate Program Director

Orlando Regional Medical Center

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