Manual Implantation of Full-Thickness Skin Microcolumns for 'Donor-Free' Skin Renewal
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Donor site re-epithelization between day 10 to 14
研究概览
简要总结
The objective of this study is to validate the proof of concept regarding the approach of manual implantation of full-thickness skin microcolumns (FTSMs) as coverage for open wounds without creating an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.
详细描述
Previously three patients have been successfully treated with the use of manual FTSM for wound coverage. To provide additional proof of concept data, this study will validate manual FTSM implantation on a larger scale with a 10-patient population. This will be measured by the following hypothesized parameters: time to re-epithelization, pigmentation, wound contraction, scar thickness, pain at the donor site and injury site healing outcome. The approach to testing this hypothesis will be to perform manual FTSM harvest, placement on the injured site, covered by an inert dressing for 10 patients with open wounds necessitating tissue coverage. The rationale is that although preliminary proof of concept data has already been obtained from three patients treated with FTSM implantation, additional proof of concept data would strengthen the conclusions made based on these cases.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8-85 years of age
- •10-125 cm2 open wound on the scalp, neck, torso or extremities necessitating tissue coverage
- •Sufficiently healthy skin to serve as a donor site
排除标准
- •Wound area involving the face*
- •Wound area involving joints*
- •Pregnancy
- •Active wound infection at potential treatment sites
- •Exposed muscle, joint, tendon, or bone within the wound bed
研究组 & 干预措施
Full-thickness skin microcolumns Implantation
implantation of FTSM on open wound
干预措施: Full-thickness skin microcolumns implantation (Procedure)
结局指标
主要结局
Donor site re-epithelization between day 10 to 14
时间窗: 10-14 days
Donor site re-epithelization between day 10 to 14
次要结局
- Donor site(up to 6 months)
- Injured site(up to 6 months)
