Epidermal Cells Delivery and Acute Burns

Burn Clinical Trial

— ENSEM  

Official title:

A Randomized Trial Comparing Recell® Autologous Epidermal Cells Harvesting Kits Versus Classic Skin Grafts for the Treatment of Acute Burn in Adults and Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00774033
• Other study ID #: P070307
• Status: Terminated
• Phase: Phase 3
• First received: October 15, 2008
• Last updated: July 25, 2012
• Start date: December 2008
• Est. completion date: May 2012

Study information

• Verified date: March 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn
• Burns

Intervention

Device:
• autologous epidermal cells harvesting kits
autologous epidermal cells harvesting kits used for the treatment of acute burn

Procedure:
• classic skin grafts
classic skin grafts used for the treatment of acute burn

Locations

Country	Name	City	State
France	Hopital Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.		at 1, 2 and 6 weeks	No
Secondary	Medical costs at complete epithelialisation		At 6, 12 and 18 months	No
Secondary	Post-operative pain		At 6 weeks	No
Secondary	Medical assessment of scar quality		at 6 weeks and 6, 12, 18 months	No
Secondary	Patient self assessment of scar		At 6, 12 and 18 months	No