Burn WoundsPhase 3MEEKADEAUNCT01330407
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
A Phase 3 study testing cryopreserved skin allografts. and Cultured Epidermal Autografts in people with Burn Wounds, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burn Wounds
- What is being tested?
- cryopreserved skin allografts. and Cultured Epidermal Autografts
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Guy Magalon contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
guy MAGALON, guy.magalon@ap-hm.fr
guy magalon
About this study
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.
Read the detailed description
10 patients presenting burn wounds over 50% of total body surface area, including at least 40 % of deep burns, will be enrolled.
- Conditions
- Burn Wounds
- Being tested
- cryopreserved skin allografts., Cultured Epidermal Autografts
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryopreserved skin allografts.Procedure or surgery
Cultured Epidermal AutograftsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| gp2 | Experimental | Cultured Epidermal Autografts Receives: Procedure: Cultured Epidermal Autografts |
| gp1 | Active comparator | cryopreserved skin allografts. Receives: Procedure: cryopreserved skin allografts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIME OF HEALING
to compare wound healing speed on the 2 treated areas, considering epithelialization rate until complete wound healing.
Measured: 2 YEARS
Secondary outcomes (1)
QUALITY OF HEALING
to assess the quality of wound healing and scar maturation.
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn WoundsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330407
- Sponsor's protocol ID
- 2009-A01247-50
- Other IDs
- 2009-31
- Acronym
- MEEKADEAU
- Status last verified
- Nov 2015
- First submitted
- 5 Apr 2011
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01330407
- Acronym / sponsor ID
- MEEKADEAU / 2009-A01247-50
- Conditions
- Burn Wounds
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gp2 | Experimental | Procedure: Cultured Epidermal AutograftsCultured Epidermal Autografts |
| gp1 | Active comparator | Procedure: cryopreserved skin allografts.cryopreserved skin allografts. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryopreserved skin allografts. | Procedure or surgery | gp1 |
| Cultured Epidermal Autografts | Procedure or surgery | gp2 |
Primary outcome
TIME OF HEALING
Time frame: 2 YEARS
to compare wound healing speed on the 2 treated areas, considering epithelialization rate until complete wound healing.
1 secondary outcome
QUALITY OF HEALING
Time frame: 2 YEARS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Magalon contact
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cryopreserved skin allografts. and Cultured Epidermal Autografts in people with Burn Wounds, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Magalon (guy.magalon@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIME OF HEALING (time frame: 2 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015; AzTrials last refreshed its copy on 8 Nov 2026.