Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS)
NCT ID: NCT00718978
Last Updated: 2008-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2003-06-30
2007-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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B
the investigators grafted sheets based on the HYAFF11p80® scaffold (the one with the lowest degree of esterification)
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).
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* all contra indications for surgery
* coagulation disorders
* infection
* allergic reactions
* collagenopathies
* malignant cancer and chemotherapy
* immunodeficiencies
* diabetes
1 Year
70 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Department of plastic and reconstructive Surgery
Principal Investigators
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nicolo' scuderi, professor
Role: STUDY_CHAIR
universita "la Sapienza" Roma
Locations
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Dipartimento Malattie Cutanee-Veneree e Chirurgia Plastica e Ricostruttiva universita' "La Sapienza" Roma
Roma, , Italy
Countries
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References
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Scuderi N, Onesti MG, Bistoni G, Ceccarelli S, Rotolo S, Angeloni A, Marchese C. The clinical application of autologous bioengineered skin based on a hyaluronic acid scaffold. Biomaterials. 2008 Apr;29(11):1620-9. doi: 10.1016/j.biomaterials.2007.12.024. Epub 2008 Jan 16.
Scuderi N, Anniboletti T, Carlesimo B, Onesti MG. Clinical application of autologous three-cellular cultured skin substitutes based on esterified hyaluronic acid scaffold: our experience. In Vivo. 2009 Nov-Dec;23(6):991-1003.
Other Identifiers
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928/07
Identifier Type: -
Identifier Source: org_study_id