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

Not Applicable

Completed

• Conditions: Giant Nevi; Burns; Ulcers
• Interventions: Procedure: CSS grafting

• Registration Number: NCT00718978
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2004-07
• Study Completion: 2007-07
• Status Verified: 2008-07
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Last Update Submitted: 2008-09-05
• Last Update Posted: 2008-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	CSS grafting	the investigators grafted sheets based on the HYAFF11® scaffold (the one with the highest degree of esterification).
B	CSS grafting	the investigators grafted sheets based on the HYAFF11p80® scaffold (the one with the lowest degree of esterification)
A-B	CSS grafting	the investigators grafted sheets based on the HYAFF11® scaffold and sheets based on the HYAFF11p80 ® scaffold

Primary Outcome Measures

Name	Time	Method
CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance	3 years maximum

Secondary Outcome Measures

Name	Time	Method
Final aesthetic outcome determined by the take of melanocytes	3 years maximum

Trial Locations

Locations (1)

Dipartimento Malattie Cutanee-Veneree e Chirurgia Plastica e Ricostruttiva universita' "La Sapienza" Roma; 🇮🇹 Roma, Italy