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

Last updated: November 18, 2015
Sponsor: Assistance Publique Hopitaux De Marseille
Overall Status: Trial Status Unknown

Phase

3

Condition

Skin Wounds

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT01330407
2009-A01247-50
2009-31
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 (deeppartial thickness and full thickness burns).

  3. Patients presenting two 300 cm² (30x10cm) non adjacent burn wound areas, of similardepth assessed by Laser Doppler Imaging, on body anterior side, functional areasexcepted.

  4. Written informed consent, signed by patient or legal representative (if patient unableto sign).

  5. Negative pregnancy test

Exclusion

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 tissuedisorder (Ehlers Danlos syndrome, Marfan syndrome), Epidermolysis Bullosa. Medicaltreatment 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

Total Participants: 10
Study Start date:
April 01, 2011
Estimated Completion Date:
March 31, 2016

Study Description

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

Connect with a study center

  • Assistance Publique Hopitaux de Marseille

    Marseille, 13354
    France

    Active - Recruiting

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