Randomized Controlled Trial of Laser Hair Depilation in Adolescents With Pilonidal Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- Recurrence of pilonidal disease
研究概览
简要总结
Pilonidal disease is a common painful condition that affects 26 per 100,000 people with an incidence of 1.1% in the young male population. Recurrence rates of pilonidal disease after initial incision and drainage and after resection have been reported to be 16% and 11% respectively. Furthermore, wound issues after resection with primary closure have been reported to be as high as 30%. In several retrospective studies and small prospective studies, laser hair removal has shown promise as an adjunct therapy to decrease recurrent infections and decrease the need for repeat surgery in adults and older adolescents. We are performing a randomized control trial of laser hair depilation plus chemical/mechanical depilation to examine outcomes related to recurrence of pilonidal disease.
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
- 11 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Fitzpatrick skin types
- •11-21 years of age
- •Diagnosis of pilonidal disease
排除标准
- •History of photosensitivity
- •Actively inflamed pilonidal sinus. These patients are invited to participate upon resolution of their inflamed sinus.
结局指标
主要结局
Recurrence of pilonidal disease
时间窗: 12 months
Recurrence is defined as a new development of pilonidal abscess, folliculitis, or draining sinus after treatment which would require antibiotic treatment, additional surgical incision and drainage or excision.
次要结局
- Disability Days(12 months)
- Health related quality of life(1 year)
研究者
Peter Minneci
Associate Professor of Surgery and Pediatrics
Nationwide Children's Hospital