Burn
Conditions
Keywords
Keratinocytes, Cell spray, Deep partial thickness burns, Full thickness burns
Brief summary
The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns
Detailed 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
Interventions
DEVICEautologous epidermal cells harvesting kits
autologous epidermal cells harvesting kits used for the treatment of acute burn
PROCEDUREclassic skin grafts
classic skin grafts used for the treatment of acute burn
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks. | at 1, 2 and 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Medical costs at complete epithelialisation | At 6, 12 and 18 months |
| Post-operative pain | At 6 weeks |
| Medical assessment of scar quality | at 6 weeks and 6, 12, 18 months |
| Patient self assessment of scar | At 6, 12 and 18 months |
Countries
France
Outcome results
None listed