Prospective Case Series on a Combination Methylene Blue, Gentian Violet, and Ovine Forestomach-derived Extracellular Matrix Dressing for Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Percent Change in Wound Size
研究概览
简要总结
The objective of this case series is to monitor time and outcome of healing of wounds associated with HS using Endoform [ovine forestomach], Hydrofera Blue [methylene blue and gentian violet], and Hypafix tape. a combination methylene blue, gentian violet, and ovine forestomach wound care product.
详细描述
Hidradenitis suppurativa (HS) is a chronic and debilitating inflammatory disease most frequently affecting the axilla, groin, and inframammary regions. Symptoms include nodules, abscesses, sinus tract formation, malodorous drainage, and scarring. These symptoms interfere with everyday activities, which can lead to social embarrassment and isolation. Patients with HS suffer psychological effects, such as increased levels of anxiety, depression, and loneliness, which impair quality of life.
Patients suffer with the burden of at home wound care for recurrent, draining nodules. Persistent lesions affect patients' lives by limiting their daily activities. Currently, patients are instructed to use gauze and tape to cover draining wounds, but this can be insufficient and difficult due to the nature and location of lesions associated with HS. Patients suffer with caring for their wounds, which can lead to frustration. Providing patients with a standard wound care regimen to take home can improve patients' quality of life and control of their disease. General recommendations for wound care in HS patients are limited. Improvements in the standard of care for wound management in HS are needed to aid patients.
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with hidradenitis suppurativa with non-healing wounds or draining abscesses/nodules
- •Individuals over 18 years of age
排除标准
- •Individuals younger than 18 years of age
- •Individuals without a diagnosis of HS
结局指标
主要结局
Percent Change in Wound Size
时间窗: Measure from Baseline to week 8
Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products
次要结局
- Change in Pain Assessment Scores(Change from week 4 to week 8)
