Topical Collagen-Silver Versus Standard Care Following Phenol Ablation of Ingrown Nails: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- time to healing
研究概览
简要总结
This study's purpose is to prospectively determine whether topical therapy with an oxidized regenerated cellulose collagen-silver compound is more effective than the current standard of topical antibiotic therapy for care following the removal of an ingrown toenail. Eighty adult patients with ingrown toenails will be recruited. Each patient will randomly be assigned to apply either topical silver sulfadiazine cream (standard antibiotic) or the novel collagen-silver compound to their nail bed daily, following removal of the ingrown portion of nail. Patients will return for follow up visits weekly, until healing has occurred or twelve weeks have passed. Healing will be defined as resolution of drainage and inflammatory changes surrounding the nail border.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ingrown toenails will be defined as any incurvated nail border that digs into the skin of the nail fold and causes pain and discomfort
排除标准
- •Patients with immunocompromised states
- •chronic steroid use
- •diabetes mellitus
- •collagen vascular disease
- •HIV infection
- •Cellulitis proximal to the hallux interphalangeal joint or peripheral vascular disease will be excluded
- •We will define peripheral vascular disease as the absence of one or more pedal pulses or the presence of dystrophic changes to the integument
研究组 & 干预措施
experimental
Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs.
干预措施: oxidized regenerated cellulose collagen-silver (Device)
Control
Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured.
干预措施: topical silver sulfadiazine cream (Drug)
结局指标
主要结局
time to healing
时间窗: weekly
次要结局
- time to return to regular shoe gear(weekly)
- days unable to work(weekly)
