Burns, Giant Nevi, Ulcers
Conditions
Keywords
bioengineered, ski, keratinocytes, fibroblasts, skin, culture, autologous, CSS, full-thickness loss of substance from:, burns, ulcers, giant nevi, cicatricial outcomes
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 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.
Interventions
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
Sponsors
Study design
Eligibility
Inclusion criteria
* of extensive full-thickness loss of substance
Exclusion criteria
* location: face * all contra indications for surgery * coagulation disorders * infection * allergic reactions * collagenopathies * malignant cancer and chemotherapy * immunodeficiencies * diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance | 3 years maximum |
Secondary
| Measure | Time frame |
|---|---|
| Final aesthetic outcome determined by the take of melanocytes | 3 years maximum |
Countries
Italy