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临床试验/NCT02264392
NCT02264392已完成不适用

Ultrasound Guided Versus Blind Incision and Drainage for the Treatment of Soft Tissue Abscesses in the Emergency Department

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2014年11月1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
发起方
入组人数
124
试验地点
2
主要终点
Failure of Therapy

研究概览

简要总结

Standard treatment for a soft tissue abscess involves incision over the area of maximum fluctuance with drainage of purulence from the abscess cavity. The use of bedside ultrasound to guide this drainage has the potential to improve treatment outcomes by ensuring complete drainage of the cavity.

Our hypothesis is that the use of ultrasound for guidance of incision and drainage of soft tissue abscesses will decrease treatment failure rate compared to standard blind incision and drainage.

This hypothesis will be tested utilizing a blinded, randomized trial comparing standard incision and drainage to ultrasound guided incision and drainage.

详细描述

  1. Background* The incidence of soft tissue infections is increasing, representing over 30 million emergency department visits per year. While there has been extensive research in recent years surrounding the use of antibiotics for soft tissue abscesses, the surgical management remains unchanged with standard therapy consisting of blind incision and drainage of the abscess cavity.

Despite incision and drainage and a spectrum of antibiotic coverage, treatment failure rates for these infections range from 5-20%. It is possible that part of this treatment failure can be attributed to inadequate abscess cavity evacuation. With blind drainage, it is possible that residual purulence or unforeseen satellite abscess cavities contribute to the persistence of the infection.

Ultrasound has been shown to aid in the identification of soft tissue abscesses and to help differentiate cellulitis from an abscess. Over the last decade, clinician performed bedside ultrasound has become a standard in the practice of emergency medicine with proficiency requirements now in place for graduating emergency medicine residents. While many practitioners have in fact adopted ultrasound in its use for the identification of abscesses, few subsequently use the ultrasound for procedural guidance.

We are specifically interested in studying the use of ultrasound for identifying the ideal location for initial incision as well as use of post procedural ultrasound to confirm complete evacuation of abscess purulence.

  1. Inclusion and Exclusion Criteria*

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

年龄范围
1 Month 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Soft tissue abscess suspected by patient history and physical exam and confirmed by bedside ultrasound
  • Able to provide written consent/ assent
  • Incision and drainage to be performed by ED physician

排除标准

  • Peritonsillar abscess
  • Pilonidal cyst, genital or perirectal abscess
  • Post-surgical wound infections
  • Previous incision and drainage for current abscess

研究组 & 干预措施

Ultrasound Guided

Active Comparator

Ultrasound Guided Incision and Drainage- Patients will undergo ultrasound guided drainage of the abscess using bedside ultrasound

干预措施: Ultrasound Guided Incision and Drainage (Procedure)

Blind I&D

Active Comparator

Blind Incision and Drainage- Patients will undergo drainage of the abscess using physical exam.

干预措施: Blind Incision and Drainage (Procedure)

结局指标

主要结局

Failure of Therapy

时间窗: 7 days

Patient with a reoccurrence of the abscess

次要结局

未报告次要终点

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Romolo Gaspari

Executive Vice Chair, Department of Emergency Medicine

University of Massachusetts, Worcester

研究点 (2)

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