Comparative Assessment of Adjuvant Effect of Cultured Epidermal Autografts Versus Skin Allografts on Wound Healing of Burns Treated With Widely Expanded Skin Autograft Using Meek Micrografting Technique MEEKADEAU
The investigators intend to conduct a comparative, monocentric prospective double-blind study with intra-subject randomization, to compare the results on wound healing of 2 adjuvant treatments to Meek micrografting technique : Cultured Epidermal Autografts and cryopreserved skin allografts.
Procedure: cryopreserved skin allografts.
Procedure: Cultured Epidermal Autografts
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparative Assessment of Adjuvant Effect of Cultured Epidermal Autografts Versus Skin Allografts on Wound Healing of Burns Treated With Widely Expanded Skin Autograft Using Meek Micrografting Technique MEEKADEAU|
- TIME OF HEALING [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]to compare wound healing speed on the 2 treated areas, considering epithelialization rate until complete wound healing.
- QUALITY OF HEALING [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]to assess the quality of wound healing and scar maturation.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Cultured Epidermal Autografts
|Procedure: Cultured Epidermal Autografts|
Active Comparator: gp1
cryopreserved skin allografts.
|Procedure: cryopreserved skin allografts.|
10 patients presenting burn wounds over 50% of total body surface area, including at least 40 % of deep burns, will be enrolled.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330407
|Contact: Guy Magalonfirstname.lastname@example.org|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: guy MAGALON email@example.com|
|Principal Investigator: guy magalon|
|Study Director:||BERNARD BELAIGUES||Assistance Publique hôpitaux de Marseille|