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
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2011
Longer than P75 for phase_3
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
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 5, 2011
CompletedFirst Posted
Study publicly available on registry
April 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedNovember 20, 2015
November 1, 2015
4.9 years
April 5, 2011
November 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
TIME OF HEALING
to compare wound healing speed on the 2 treated areas, considering epithelialization rate until complete wound healing.
2 YEARS
Secondary Outcomes (1)
QUALITY OF HEALING
2 YEARS
Study Arms (2)
gp2
EXPERIMENTALCultured Epidermal Autografts
gp1
ACTIVE COMPARATORcryopreserved skin allografts.
Interventions
Eligibility Criteria
You may qualify if:
- Males and females between 18 to 60 years of age
- Burns \> 50% Total Body Surface Area (TBSA), including deep burns \> 40% TBSA (deep partial thickness and full thickness burns).
- 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.
- Written informed consent, signed by patient or legal representative (if patient unable to sign).
- Negative pregnancy test
You may not qualify if:
- Chemical or electric burns
- Short delay life threatening disease, by itself or when associated with burns.
- Chronic systemic steroïd intake,
- 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..).
- Prisonners
- Pregnant women
- Patient under guardianship.
- Participation in another investigational trial within this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
BERNARD BELAIGUES
Assistance Publique hôpitaux de Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2011
First Posted
April 7, 2011
Study Start
April 1, 2011
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
November 20, 2015
Record last verified: 2015-11