Randomized Clinical Trial of Wound Packing Following Incision and Drainage of Superficial Skin Abscesses in the Pediatric Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Healing (resolution, cosmesis, complications and recurrence)
研究概览
简要总结
Superficial skin and soft tissue abscess are frequently managed by opening them up with a procedure called "incision and drainage". It is routine practice in the United States to place packing material inside the abscess cavity after opening them up, in order to promote better wound healing and limit abscess recurrence. However, this practice has never been systematically studied or proven to decrease complications or improve healing. Patients with wound packing usually return to the emergency room or practice setting for multiple "wound checks" and dressing/packing changes which lead to missed days from work or school and utilization of healthcare resources. This procedure can often be painful and may even require conscious sedation (and the risks entailed) especially in children. With rates of superficial skin and soft tissue abscesses on the rise, and emergency room resources being stretched, it is important to determine whether packing wounds is necessary or even advantageous to patients.
This study is the first to systematically evaluate the efficacy of wound packing after superficial skin or soft tissue abscess incision and drainage in children. The investigators will be evaluating wound healing, complications, recurrence and pain associated with packing both short and long term. In addition, the investigators will also be evaluating the utility of bedside point-of-care ultrasound use in predicting the presence of pus inside the abscess cavity. This test may be useful to determine whether incision and drainage is necessary for an individual who has a skin infection that is suspicious for an abscess.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 24 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 - 24 years (i.e. any child seen in PED)
- •Suspected abscess deemed to need incision & drainage by attending physician or fellow
- •Size of abscess is greater than or equal to 1cm
- •Parent or patient consent, and child assent
排除标准
- •Location of abscess on face, perianal, or genitals
- •History of recurrent or chronic abscess
- •Multiple abscesses requiring drainage at current visit
- •Immunocompromised or unstable patient
- •HIV, transplant recipient, immune deficiency syndrome
- •immunosuppressive medications
- •Wound already open/draining
- •Previous participation in trial
- •Patient will not be following up / managed by PES (e.g. surgical site)
结局指标
主要结局
Healing (resolution, cosmesis, complications and recurrence)
时间窗: one month
Ultrasound test characteristics
时间窗: day one
次要结局
- Parental/patient satisfaction(one month)
- Cost-effectiveness(one month)
