跳至主要内容
临床试验/NCT05223998
NCT05223998Enrolling By Invitation不适用

Manual Implantation of Full-Thickness Skin Microcolumns for 'Donor-Free' Skin Renewal

The Metis Foundation1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年10月28日最近更新:
适应症
干预措施

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

Experimental

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)

研究者

发起方
The Metis Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验