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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01330407
First received: April 5, 2011
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Burn Wounds
Procedure: cryopreserved skin allografts.
Procedure: Cultured Epidermal Autografts
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • TIME OF HEALING [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]
    to compare wound healing speed on the 2 treated areas, considering epithelialization rate until complete wound healing.


Secondary Outcome Measures:
  • QUALITY OF HEALING [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]
    to assess the quality of wound healing and scar maturation.


Estimated Enrollment: 10
Study Start Date: March 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gp2
Cultured Epidermal Autografts
Procedure: Cultured Epidermal Autografts
Active Comparator: gp1
cryopreserved skin allografts.
Procedure: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330407

Contacts
Contact: Guy Magalon guy.magalon@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: guy MAGALON       guy.magalon@ap-hm.fr   
Principal Investigator: guy magalon         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE, direction de la recherche
ClinicalTrials.gov Identifier: NCT01330407     History of Changes
Other Study ID Numbers: 2009-A01247-50, 2009-31
Study First Received: April 5, 2011
Last Updated: March 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014