A Bioelectric Dressing for Post De-Roofing Treatment of Hidradenitis Suppurativa (HS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Healing Rate
研究概览
简要总结
The primary purpose of this study is to test if the use of a bioelectric dressing can improve healing after a surgical procedure called de-roofing.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years old and older.
- •Have diagnosis of HS confirmed by a dermatologist
- •Have at least two ancillary tunnels in separate anatomical sites
- •Able to provide informed consent
排除标准
- •Individuals who are not yet adults
- •Subject is allergic to any of the materials and dressings involved in the procedures
- •Women known to be pregnant
- •Prisoners
- •Subjects, who in the opinion of the PI, cannot comply with hope application of the treatment
研究组 & 干预措施
Bioelectric Dressing
Participants acting as their own control. Each participant is counted as 2 sites (2 axilla). Participants undergoing standard of care deroofing surgery will be randomized to dressing assignment per axilla: one axilla will receive the bioelectric dressing, and the contralateral axilla will receive the standard gauze dressing for up to 8 weeks. Side assignment (right vs. left) will be determined by randomization.
干预措施: Bioelectric Dressing (Device)
Bioelectric Dressing
Participants acting as their own control. Each participant is counted as 2 sites (2 axilla). Participants undergoing standard of care deroofing surgery will be randomized to dressing assignment per axilla: one axilla will receive the bioelectric dressing, and the contralateral axilla will receive the standard gauze dressing for up to 8 weeks. Side assignment (right vs. left) will be determined by randomization.
干预措施: Standard Gauze Dressing (Other)
Standard Gauze Dressing
Participants acting as their own control. Each participant is counted as 2 sites (2 axilla). Participants undergoing standard of care deroofing surgery will be randomized to dressing assignment per axilla: one axilla will receive the bioelectric dressing, and the contralateral axilla will receive the standard gauze dressing for up to 8 weeks. Side assignment (right vs. left) will be determined by randomization.
干预措施: Bioelectric Dressing (Device)
Standard Gauze Dressing
Participants acting as their own control. Each participant is counted as 2 sites (2 axilla). Participants undergoing standard of care deroofing surgery will be randomized to dressing assignment per axilla: one axilla will receive the bioelectric dressing, and the contralateral axilla will receive the standard gauze dressing for up to 8 weeks. Side assignment (right vs. left) will be determined by randomization.
干预措施: Standard Gauze Dressing (Other)
结局指标
主要结局
Healing Rate
时间窗: Up to 8 weeks
The healing rate of post-surgical wounds will be reported as the area reduction in cm\^2/per day.
次要结局
- Average Time to Complete Healing(Up to 8 weeks)
- Number of Subjects With Complete Healing(Up to 8 weeks)
- Number of Subjects With Nodule and/or Tunnel Recurrence(Up to 8 weeks)
- Average Pain as Assessed by the Visual Analogue Scale (VAS)(Up to 8 weeks)
- Number of Subjects With Tenderness at Surgical Sites(Up to 8 weeks)
- Quality of Post-surgical Scars as Measured by Modified Vancouver Scar Scale(Up to 8 weeks)
- Amount of Exudate at Surgical Site(Up to 8 weeks)
- Shoulder Range of Motion(Up to 8 weeks)
- Number of Dressings Used Through to Healing Day(Up to 8 weeks)
- Average Pain as Assessed by the Visual Analogue Scale (VAS)(Day 2 (24 hours post procedure))
- Days of Work Lost(Up to 8 weeks)
- Change in Quality of Life as Measured by the DLQI(Baseline, Up to 8 weeks)
- Tissue Analysis of Microbiome(Up to 8 weeks)
研究者
Hadar Lev-Tov
Assistant Professor of Clinical
University of Miami