Derma-Stent Novel Abscess Packing Device (Pilot Study)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Likelihood of self removal
研究概览
简要总结
In this research study, a device called the Derma-Stent will be tested. The sponsor of the study, Mar-Med Company, will supply the device. This device is used to drain a cutaneous abscess, which is a skin infection that results in buildup of pus under the skin. Currently, the normal treatment for this abscess is to cut and drain and the wound, and later pack the wound with gauze. Packing is done to prevent the pus to accumulate again. But regular gauze is difficult for patient to remove themselves, so another visit to the doctor is usually necessary. The Derma-Stent device will be tested to see how easily patients can remove this by themselves and if it is less painful and more effective than normal gauze packing.
详细描述
Background:
Cutaneous abscess is an infectious condition that affects millions of people each year, and the incidence is on the rise. Between 1993 and 2005, the annual number of emergency department (ED) visits for skin and soft tissue infections increased from 1.2 to 3.4 million, and this largely attributed to a rise in the prevalence of Methicillin Resistant Staphylococcus Aureus (MRSA) in the community.
The standard treatment for cutaneous abscess is incision and drainage at bedside in the ED. Following this procedure, many clinicians insert a strip of gauze, known as packing, to maintain the open surgical incision, enhance drainage, and prevent re-accumulation of the abscess. If the abscess is packed, patients typically have to return in 2-3 days for a repeat visit to have the packing removed. The present standard of care, gauze packing, is difficult for patients to remove alone, as the packing itself becomes impregnated with pus and blood. Additionally, the packing procedure can be painful, despite the use of local anesthetics.
A newer approach advocates for the use of a silicon string, known as a PDS loop for purposes of packing and drainage. While this approach can reduce pain, and is equally effective in terms of healing time, and treatment failure, the PDS, or Vessiloop is not readily available in emergency departments and outpatient clinics, as it is a specialized sterile surgical device used in vascular procedures. Furthermore, this procedure does not facilitate irrigation of the abscess cavity, since a much smaller incision is made. Finally, the PDS loop requires a surgical knot which may come loose.
Objective:
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ED patient > 18, <
- •Abscess total dimensions (z+y+z) by ultrasound greater or equal to 5 cm.
- •Consent to participate in research protocol.
- •Assessment by attending physician that the abscess will require packing.
排除标准
- •Patients requiring admission for skin and soft tissue infection.
- •Abscess drainage requiring procedural sedation.
- •Abscesses requiring incision and drainage in the operating room.
- •Inability to comprehend consent and follow up instructions.
- •Pregnant women.
结局指标
主要结局
Likelihood of self removal
时间窗: 3-5 days
Likelihood of self removal, as measured on a 1-10 Likert scale.
次要结局
- Cosmetic Result(3-5 day and one month)
- Clinical Failure Rate(32 days after baseline)
- Recurrence Rate of Abscess(3-5 day and one month follow-up)
- Pain during procedure and packing removal(baseline and 3-5 day)
研究者
Aaron Brody, MD, MPH
Assistant Professor
Wayne State University