Laser Hair Removal for Primary Treatment of Pilonidal Disease Requiring Surgical Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Incidence of disease-free remission
研究概览
简要总结
This project is a pilot study to determine if symptomatic pilonidal disease can be primarily managed with laser hair removal vs surgery.
详细描述
This project will consist of surgical evaluation in pediatric surgery or colorectal surgery clinics, referral to dermatology clinic for informed consent, and if enrolled, participation in up to 8 laser hair removal sessions with regular follow-up for a period of 2 years after completion of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic pilonidal disease, who meet criteria for surgical intervention:
- •Experience two or more episodes of infection or abscess in the past 12 months
- •Have pain or drainage for a total of more than 1 month in the past 12 months
- •Missed a total of more than 1 week of school or work in the past 12 months
- •English-speaking
排除标准
- •Patients who have co-morbidities that prevent them from becoming a surgical candidate
- •Previous history of laser hair removal in the gluteal cleft (prior to initial enrollment)
- •Previous excision of pilonidal sinus (prior to initial enrollment)
- •Non-English speaking
结局指标
主要结局
Incidence of disease-free remission
时间窗: up to 2 years
Disease free rate among those subjects who only required laser therapy. Disease-free remission will be assessed at 12 and 24 months.
Disease recurrence rate among subjects who subsequently require surgical intervention.
时间窗: up to 2 years
Rate of recurrence of pilonidal disease among subjects who participated in the study but also required surgical intervention.
次要结局
- Cost-benefit analysis of laser hair-treated patients versus matched historical control.(up to 2 years)
- Characterization of the degree of intervention required to obtain positive results.(up to 2 years)
- Number of missed school or work days(Up to 18 months)
- Assessment of Pain via Promis 3A Pain Short Form(up to 18 months)
- Number of Days Participants Experience Drainage(up to 18 months)