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

University of Roma La Sapienza

Status: Completed

Conditions: Giant Nevi; Burns; Ulcers

Treatments: Procedure: CSS grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT00718978

928/07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 1 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 3 patient groups

B

Other group

Description:

the investigators grafted sheets based on the HYAFF11p80® scaffold (the one with the lowest degree of esterification)

Treatment:

Procedure: CSS grafting

A

Other group

Description:

the investigators grafted sheets based on the HYAFF11® scaffold (the one with the highest degree of esterification).

Treatment:

Procedure: CSS grafting

A-B

Other group

Description:

the investigators grafted sheets based on the HYAFF11® scaffold and sheets based on the HYAFF11p80 ® scaffold

Treatment:

Procedure: CSS grafting