Burns Clinical Trial
Official title:
Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS) Based on Esterified Hyaluronic Acid Scaffold: Our Experience
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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