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

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Unknown; Phase 3

Conditions: Burn Wounds

Treatments: Procedure: cryopreserved skin allografts.; Procedure: Cultured Epidermal Autografts

Study type: Interventional

Funder types: Other

Identifiers

NCT01330407

2009-31 (Other Identifier)

2009-A01247-50

Details and patient eligibility

About

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.

Full description

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

10 participants in 2 patient groups

gp2

Experimental group

Description:

Cultured Epidermal Autografts

Treatment:

Procedure: Cultured Epidermal Autografts

gp1

Active Comparator group

Description:

cryopreserved skin allografts.

Treatment:

Procedure: cryopreserved skin allografts.