Back to resultsComparative 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)
Primary Purpose
Burn Wounds
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
cryopreserved skin allografts.
Cultured Epidermal Autografts
Sponsored by
About this trial
This is an interventional treatment trial for Burn Wounds
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Assistance Publique Hopitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
gp2
gp1
Arm Description
Cultured Epidermal Autografts
cryopreserved skin allografts.
Outcomes
Primary Outcome Measures
TIME OF HEALING
to compare wound healing speed on the 2 treated areas, considering epithelialization rate until complete wound healing.
Secondary Outcome Measures
QUALITY OF HEALING
to assess the quality of wound healing and scar maturation.
Full Information
NCT ID
NCT01330407
First Posted
April 5, 2011
Last Updated
November 18, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01330407
Brief 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
Acronym
MEEKADEAU
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gp2
Arm Type
Experimental
Arm Description
Cultured Epidermal Autografts
Arm Title
gp1
Arm Type
Active Comparator
Arm Description
cryopreserved skin allografts.
Intervention Type
Procedure
Intervention Name(s)
cryopreserved skin allografts.
Intervention Type
Procedure
Intervention Name(s)
Cultured Epidermal Autografts
Primary Outcome Measure Information:
Title
TIME OF HEALING
Description
to compare wound healing speed on the 2 treated areas, considering epithelialization rate until complete wound healing.
Time Frame
2 YEARS
Secondary Outcome Measure Information:
Title
QUALITY OF HEALING
Description
to assess the quality of wound healing and scar maturation.
Time Frame
2 YEARS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guy Magalon
Email
guy.magalon@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
guy MAGALON
Email
guy.magalon@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
guy magalon
12. IPD Sharing Statement
Learn more about this trial
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
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