跳至主要内容
临床试验/NCT00718978
NCT00718978已完成不适用

Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS) Based on Esterified Hyaluronic Acid Scaffold: Our Experience

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2003年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance

研究概览

简要总结

The aim of this work was to present the investigators experience in the use of autologous three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes, melanocytes and fibroblasts attached to a scaffold of hyaluronic acid. This method represents a surgical alternative in the treatment of a variety of pathologies, including burns, ulcers and giant nevi.

详细描述

Background and Objective:

Permanent wound closure remains a limiting factor in the closure of extensive, full-thickness loss of substance. The aim of this work was to present our experience in the use of autologous three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes, melanocytes and fibroblasts attached to a scaffold of hyaluronic acid. This method represents a surgical alternative in the treatment of a variety of pathologies, including burns, ulcers and giant nevi.

Methods:

CSS were obtained from full-thickness skin biopsies collected after enrollment of 11 patients in a study protocol approved by the local Institutional Review Boards of the "La Sapienza" University of Rome. CSS consisted of a structure characterized by the presence of a pluristratified epithelial cell surface with melanocytes (relation 1/20) and a basement of fibroblasts kept together by an esterified hyaluronic acid scaffold that can be surgically manipulated, and is gradually reabsorbed after implantation and substituted by the host connectival stroma.

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
1 Year 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • of extensive full-thickness loss of substance

排除标准

  • location: face
  • all contra indications for surgery
  • coagulation disorders
  • infection
  • allergic reactions
  • collagenopathies
  • malignant cancer and chemotherapy
  • immunodeficiencies

结局指标

主要结局

CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance

时间窗: 3 years maximum

次要结局

  • Final aesthetic outcome determined by the take of melanocytes(3 years maximum)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other

研究点 (2)

Loading locations...

相似试验