Epidermal Cells Delivery and Acute Burns (ENSEM)

Assistance Publique - Hôpitaux de Paris

Status and phase: Terminated; Phase 3

Conditions: Burn

Treatments: Device: autologous epidermal cells harvesting kits; Procedure: classic skin grafts

Study type: Interventional

Funder types: Other

Identifiers

NCT00774033

P070307

Details and patient eligibility

About

The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns

Full description

Comparing the impact in terms of cicatrisation duration and costs between 2 treatments of deep 2nd and 3rd degree burns.

Determine if the costs of the innovating treatment RECELL®, a priori more expensive, are counterbalanced by a shorter cicatrisation duration and an improved evolution versus a conventional strategy.

Give an information about efficiency improvement of RECELL® with additional costs

Enrollment: 51 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Thermal burns requiring surgical debridement
• Area involved < 1260cm²

Exclusion criteria

• local or systemic infection
• conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)
• hypersensitivity to trypsin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

1

Experimental group

Description:

Treatment of acute burn in adults and children by epidermal cell spray

Treatment:

Device: autologous epidermal cells harvesting kits

2

Active Comparator group

Description:

Treatment of acute burn in adults and children by classic skin grafts

Treatment:

Procedure: classic skin grafts