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


N/A
1 Year
70 Years
Not Enrolling
Both
Burns, Ulcers, Giant Nevi

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 years maximum

Safety Issue:

Yes

Principal Investigator

nicolo' scuderi, professor

Investigator Role:

Study Chair

Investigator Affiliation:

universita "la Sapienza" Roma

Authority:

Italy: Ethics Committee

Study ID:

928/07

NCT ID:

NCT00718978

Start Date:

June 2003

Completion Date:

July 2007

Related Keywords:

  • Burns
  • Ulcers
  • Giant Nevi
  • bioengineered
  • ski
  • keratinocytes
  • fibroblasts
  • skin
  • culture
  • autologous
  • CSS
  • full-thickness loss of substance from:
  • burns
  • ulcers
  • giant nevi
  • cicatricial outcomes
  • Nevus
  • Ulcer

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