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临床试验/NCT03911518
NCT03911518撤回不适用

Loop vs. Traditional Incision and Drainage: A Randomized Controlled Pilot Trial

Gary Peksa0 个研究点开始时间: 2019年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Rate of Clinical Cure

研究概览

简要总结

This is a multicenter randomized controlled trial of loop drainage versus traditional incision and drainage in adult patients presenting to the emergency department.

详细描述

BACKGROUND AND SIGNIFICANCE

The usual care in the United States for abscess management is generally incision and drainage. There have been various techniques described for incision and drainage: 1. incision and drainage followed by healing by secondary intention, 2. Incision and drainage followed by primary closure, and 3. Loop drainage (more recently, the topic of this study) with subsequent loop removal and healing by secondary intention. The treatment failure rate for traditional incision and drainage is variable, but can range from 10-30%. Costs associated with treatment failure are between $1,000 and $2,0005. The relatively high failure rate associated with traditional incision and drainage has led to research into less invasive, more effective techniques. In 2010, the loop drainage technique was first described. This technique consists of making 2 small incisions on either end of the abscess cavity followed by pulling a small drain through the incisions and then tying the drain in place. It remains in place and is removed once no further drainage is noticed (usually in 10-14 days). Original studies were primarily done by pediatric surgeons using vessel loops or penrose drains.

In 2014, the concept of using the cuff from the bottom of a sterile glove was introduced. This allows for this technique to easily be used with materials found easily in any emergency department. The amount of research done with this technique on adults is limited. To date, only two studies with a total of 109 patients evaluated loop drainage in adults. One of these studies was retrospective and included only 63 patients. The other prospective study was limited in that it included only 46 patients. Given the demonstration of increased clinical cure rate in pediatric populations and the potential for increased clinical cure rates in adults, more study into this topic is worthwhile to determine the optimal approach to adult subcutaneous abscess drainage.

STUDY DESCRIPTION

This study will be a pilot study and multi-center prospective randomized controlled trial evaluating loop drainage compared to conventional incision and drainage in adults older than 18 who have simple, purulent, cutaneous abscesses deemed amenable to outpatient incision and drainage by the attending clinician.

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)

盲法说明

An investigator blinded to treatment assignment determine the cosmetic healing rate at 90 days

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults age 18 years or older
  • Abscess is considered simple, purulent, and cutaneous
  • Abscess is deemed amenable to outpatient drainage

排除标准

  • Inability to speak English
  • Abscess location of breast or face
  • Pilonidal abscesses
  • Concurrent use of chemotherapy or steroids
  • Allergy to sulfa/trimethoprim or lidocaine
  • Inability to provide consent
  • Incarcerated patients
  • Inability to give a valid contact number or email address
  • Presence of multiple abscesses
  • Abscess size less than 2 cm
  • Pregnant patients
  • History of glucose-6-phosphate dehydrogenase deficiency
  • History of Steven Johnson's Syndrome
  • Patients with fever greater than 100.4 Fahrenheit

研究组 & 干预措施

Control

Active Comparator

Incision and drainage.

干预措施: Incision and drainage (Procedure)

Intervention

Experimental

Loop drainage.

干预措施: Loop drainage (Procedure)

结局指标

主要结局

Rate of Clinical Cure

时间窗: Days 10-14

Defined as healing of the abscess without the need for further clinical intervention (change in antibiotics, repeat drainage, or admission)

次要结局

  • Intra-Procedure Pain Rating(Day 0)
  • Time to Complete Drainage(Day 0)
  • Patient Satisfaction: Numeric rating scale(Days 0, 10-14)
  • Provider Satisfaction: Numeric rating scale(Day 0)
  • Recurrence Rate(Day 30)
  • Cosmetic Healing(Day 90)

研究者

发起方
Gary Peksa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gary Peksa

Co-investigator; Assistant Professor, Emergency Medicine

Rush University Medical Center

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