Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS)

This study has been completed.
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00718978
First received: July 18, 2008
Last updated: September 5, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention
Burns
Ulcers
Giant Nevi
Procedure: CSS grafting

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

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance [ Time Frame: 3 years maximum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Final aesthetic outcome determined by the take of melanocytes [ Time Frame: 3 years maximum ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: June 2003
Study Completion Date: July 2007
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
B
the investigators grafted sheets based on the HYAFF11p80® scaffold (the one with the lowest degree of esterification)
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
A
the investigators grafted sheets based on the HYAFF11® scaffold (the one with the highest degree of esterification).
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
A-B
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

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.

  Eligibility

Ages Eligible for Study:   1 Year to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00718978

Locations
Italy
Dipartimento Malattie Cutanee-Veneree e Chirurgia Plastica e Ricostruttiva universita' "La Sapienza" Roma
Roma, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Chair: nicolo' scuderi, professor universita "la Sapienza" Roma
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: nicolo' scuderi, Department of plastic and reconstructive Surgery
ClinicalTrials.gov Identifier: NCT00718978     History of Changes
Other Study ID Numbers: 928/07
Study First Received: July 18, 2008
Last Updated: September 5, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
bioengineered
ski
keratinocytes
fibroblasts
skin
culture
autologous
CSS
full-thickness loss of substance from:
burns
ulcers
giant nevi
cicatricial outcomes

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014