NCT03796988已完成不适用
Autologous Regeneration of Tissue (ART) for Wound Healing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change of Pain on Harvesting of Skin at Donor Site.
研究概览
简要总结
The purpose of this research study is to learn about a new device, Autologous Regeneration of Tissue (ART), for collecting skin grafts from participant's own skin.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults from 18 to 90 years of age.
- •Patients that have a chronic wound in any area of the body defined as having been present for at least 30 days of duration.
- •Able and willing to give consent for the study.
排除标准
- •Pregnant women (Urine hCG test will be performed at baseline on women of child bearing potential).
- •Adults unable to consent.
- •Prisoners.
- •Subjects requiring concurrent systemic antimicrobials during the study period for any infection.
- •Subjects with leg lesions and clinically significant and unreconstructed peripheral arterial disease.
- •Subjects who are receiving immunosuppressive agents, radiation therapy, or cytotoxic agents.
- •Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin).
- •Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).
结局指标
主要结局
Change of Pain on Harvesting of Skin at Donor Site.
时间窗: Baseline, Day 56
Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 millimeters (no pain) to 100 millimeters (worst possible pain)
Time to Healing of Donor Sites
时间窗: Up to Day 56
At each weekly visit, the donor site will be assessed for healing based on clinical observation as measured by number of days from procedure.
次要结局
- Wound Healing of Recipient Site(Up to Day 56)
- Histologic Evaluation(Up to Day 56)
研究者
Hadar Lev-Tov
Assistant Professor
University of Miami
研究点 (2)
Loading locations...
相似试验
撤回
不适用
Autologous Regenerative Technology (ART) For Wound HealingChronic WoundsNCT03368534Stanford University
已完成
不适用
Development of a new tissue regeneration technology using human adipose-derived stem cellJPRN-jRCT1090220126Junko Nakahira30
已完成
不适用
A Prospective Clinical Study Evaluating the Harvesting of MicograftsChronic WoundNCT05076578SerenaGroup, Inc.20
已完成
1 期
Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound HealingSkin GraftNCT00856934Centre Hospitalier Universitaire Vaudois45
撤回
不适用
The Healing of Soft Tissue Augmentation by Acellular Dermal Matrix and Autogenous Subepithelial Connective Tissue GraftGingival Recession, GeneralizedGraft ReactionNCT03954028University of Florida