Informations générales (source: ClinicalTrials.gov)
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 (MEEKADEAU)
Interventional
Phase 3
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
avril 2011
mars 2016
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille - 13354 - Marseille - France | guy MAGALON | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Males and females between 18 to 60 years of age
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
1. Males and females between 18 to 60 years of age
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
1. Chemical or electric burns
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