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临床试验/NCT02822768
NCT02822768招募中不适用

Is Routine Packing of Cutaneous Abscesses Necessary?

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2016年8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
招募中
入组人数
196
试验地点
1
主要终点
Percentage of patients needing further treatment

研究概览

简要总结

The goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if routine packing of the abscess cavity affects the need for further interventions such as repeat incision and drainage, antibiotic administration or hospital admission.

详细描述

Study protocol:

  1. Identification of a patient with a cutaneous abscess requiring incision and drainage
  2. Written consent obtained from the patient
  3. Study materials will be obtained
  • Enrolling physician fills out pre-procedure information (see data sheet)

  • Enrollment data sheet has instructions indicating whether patient is to receive packing or not

  • Use of random number generator to randomize all packets

  • Provider does abscess incision and drainage with or without packing according to the instructions

  • Enrolling physician fills out post-procedure information (see data sheet)

  • Patient returns within 48 hours for wound check with removal of packing if performed

  • Research coordinator or study physician calls the patient within 14 and 30 days after the procedure for follow-up

  • Information from a return visit and/or the telephone follow-up

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • All patients 18 years of age and above
  • Patients that require a cutaneous abscess incision and drainage
  • English-speaking subjects only

排除标准

  • Unable to return for 48-hour follow-up.
  • Patients being admitted to the hospital or going to the operating room for incision and drainage
  • Pregnant patients
  • Patients less than 18 years of age
  • Prisoners or persons in police custody
  • Patients with infected bursa
  • Non-English speaking subjects

研究组 & 干预措施

Packing

Active Comparator

The patient is to have a long piece of gauze within the abscess cavity in an attempt to keep it open and allow purulent material to continue to drain after the initial incision and release of purulent material has been performed.

干预措施: Packing (Procedure)

No packing

Placebo Comparator

The patient is not to have packing of the abscess as part of the incision and drainage procedure

干预措施: No packing (Other)

结局指标

主要结局

Percentage of patients needing further treatment

时间窗: 14 days

follow-up call to determine if patient required further treatment beyond routine care

次要结局

  • Visual Analog Scale for Pain (VAS pain) post procedure(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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