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临床试验/NCT04354012
NCT04354012已完成2 期

Prospective Case Series on a Combination Methylene Blue, Gentian Violet, and Ovine Forestomach-derived Extracellular Matrix Dressing for Hidradenitis Suppurativa

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年2月4日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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