Ignite Creation Date:
2024-05-05 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00718978
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
2008-07-18
Brief Title:
Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes CSS
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes CSS Based on Esterified Hyaluronic Acid Scaffold Our Experience
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 120 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
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 120 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None