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
NCT ID: NCT01330407
Last Updated: 2015-11-20
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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UNKNOWN
PHASE3
10 participants
INTERVENTIONAL
2011-04-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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gp2
Cultured Epidermal Autografts
Cultured Epidermal Autografts
gp1
cryopreserved skin allografts.
cryopreserved skin allografts.
Interventions
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cryopreserved skin allografts.
Cultured Epidermal Autografts
Eligibility Criteria
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Inclusion Criteria
2. Burns \> 50% Total Body Surface Area (TBSA), including deep burns \> 40% TBSA (deep partial thickness and full thickness burns).
3. Patients presenting two 300 cm² (30x10cm) non adjacent burn wound areas, of similar depth assessed by Laser Doppler Imaging, on body anterior side, functional areas excepted.
4. Written informed consent, signed by patient or legal representative (if patient unable to sign).
5. Negative pregnancy test
Exclusion Criteria
2. Short delay life threatening disease, by itself or when associated with burns.
3. Chronic systemic steroïd intake,
4. Pre-existing diseases interfering with wound healing : inherited connective tissue disorder (Ehlers Danlos syndrome, Marfan syndrome), Epidermolysis Bullosa. Medical treatment interfering with wound healing (retinoids..).
5. Prisonners
6. Pregnant women
7. Patient under guardianship.
8. Participation in another investigational trial within this trial
18 Years
60 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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BERNARD BELAIGUES
Role: STUDY_DIRECTOR
Assistance Publique hôpitaux de Marseille
Locations
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Assistance Publique Hopitaux de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2009-31
Identifier Type: OTHER
Identifier Source: secondary_id
2009-A01247-50
Identifier Type: -
Identifier Source: org_study_id