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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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01330407
Acronym
MEEKADEAU
Enrollment
10
Registered
2011-04-07
Start date
2011-04-30
Completion date
2016-03-31
Last updated
2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Wounds

Brief summary

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.

Detailed description

10 patients presenting burn wounds over 50% of total body surface area, including at least 40 % of deep burns, will be enrolled.

Interventions

PROCEDUREcryopreserved skin allografts.
PROCEDURECultured Epidermal Autografts

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
TIME OF HEALING2 YEARSto compare wound healing speed on the 2 treated areas, considering epithelialization rate until complete wound healing.

Secondary

MeasureTime frameDescription
QUALITY OF HEALING2 YEARSto assess the quality of wound healing and scar maturation.

Countries

France

Contacts

Primary ContactGuy Magalon
guy.magalon@ap-hm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026