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

Burn Wounds Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01330407
• Other study ID #: 2009-A01247-50
• Secondary ID: 2009-31
• Status: Recruiting
• Phase: Phase 3
• First received: April 5, 2011
• Last updated: November 18, 2015
• Start date: April 2011
• Est. completion date: March 2016

Study information

• Verified date: November 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Guy Magalon
• Email: guy.magalon[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn Wounds
• Burns

Intervention

Procedure:
• cryopreserved skin allografts.

• Cultured Epidermal Autografts

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIME OF HEALING	to compare wound healing speed on the 2 treated areas, considering epithelialization rate until complete wound healing.	2 YEARS	No
Secondary	QUALITY OF HEALING	to assess the quality of wound healing and scar maturation.	2 YEARS	No