An interventional study of CSS grafting in Burns, Ulcers and Giant Nevi, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 1 Year to 70 Years. Per ClinicalTrials.gov, last updated 2008-09-09.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
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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Exclusion Criteria:
the investigators grafted sheets based on the HYAFF11p80® scaffold (the one with the lowest degree of esterification)
Procedure: CSS grafting
the investigators grafted sheets based on the HYAFF11® scaffold (the one with the highest degree of esterification).
Procedure: CSS grafting
the investigators grafted sheets based on the HYAFF11® scaffold and sheets based on the HYAFF11p80 ® scaffold
Procedure: CSS grafting
grafting of autologous three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes, melanocytes and fibroblasts attached to a scaffold of hyaluronic acid (HYAFF11® and HYAFF11p80®) obtained from full-thickness skin biopsies to repair full-thickness loss of substance
CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance
Time frame: 3 years maximum
Final aesthetic outcome determined by the take of melanocytes
Time frame: 3 years maximum
This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza