Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS)
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 18, 2008
CompletedFirst Posted
Study publicly available on registry
July 21, 2008
CompletedSeptember 9, 2008
July 1, 2008
1.1 years
July 18, 2008
September 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance
3 years maximum
Secondary Outcomes (1)
Final aesthetic outcome determined by the take of melanocytes
3 years maximum
Study Arms (3)
B
OTHERthe investigators grafted sheets based on the HYAFF11p80® scaffold (the one with the lowest degree of esterification)
A
OTHERthe investigators grafted sheets based on the HYAFF11® scaffold (the one with the highest degree of esterification).
A-B
OTHERthe investigators grafted sheets based on the HYAFF11® scaffold and sheets based on the HYAFF11p80 ® scaffold
Interventions
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
You may qualify if:
- of extensive full-thickness loss of substance
You may not qualify if:
- location: face
- all contra indications for surgery
- coagulation disorders
- infection
- allergic reactions
- collagenopathies
- malignant cancer and chemotherapy
- immunodeficiencies
- diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dipartimento Malattie Cutanee-Veneree e Chirurgia Plastica e Ricostruttiva universita' "La Sapienza" Roma
Roma, 00161, Italy
Related Publications (2)
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.
PMID: 18201759BACKGROUNDScuderi 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.
PMID: 20023246DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
nicolo' scuderi, professor
universita "la Sapienza" Roma
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 18, 2008
First Posted
July 21, 2008
Study Start
June 1, 2003
Primary Completion
July 1, 2004
Study Completion
July 1, 2007
Last Updated
September 9, 2008
Record last verified: 2008-07