Back to resultsEpidermal Cells Delivery and Acute Burns (ENSEM)
Primary Purpose
Burn
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
autologous epidermal cells harvesting kits
classic skin grafts
Sponsored by
About this trial
This is an interventional treatment trial for Burn focused on measuring Keratinocytes, Cell spray, Deep partial thickness burns, Full thickness burns
Eligibility Criteria
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
Sites / Locations
- Hopital Trousseau
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Treatment of acute burn in adults and children by epidermal cell spray
Treatment of acute burn in adults and children by classic skin grafts
Outcomes
Primary Outcome Measures
80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.
Secondary Outcome Measures
Medical costs at complete epithelialisation
Post-operative pain
Medical assessment of scar quality
Patient self assessment of scar
Full Information
NCT ID
NCT00774033
First Posted
October 15, 2008
Last Updated
July 25, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00774033
Brief Title
Epidermal Cells Delivery and Acute Burns
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Not enough patients included
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn
Keywords
Keratinocytes, Cell spray, Deep partial thickness burns, Full thickness burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Treatment of acute burn in adults and children by epidermal cell spray
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment of acute burn in adults and children by classic skin grafts
Intervention Type
Device
Intervention Name(s)
autologous epidermal cells harvesting kits
Other Intervention Name(s)
Recell®
Intervention Description
autologous epidermal cells harvesting kits used for the treatment of acute burn
Intervention Type
Procedure
Intervention Name(s)
classic skin grafts
Intervention Description
classic skin grafts used for the treatment of acute burn
Primary Outcome Measure Information:
Title
80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.
Time Frame
at 1, 2 and 6 weeks
Secondary Outcome Measure Information:
Title
Medical costs at complete epithelialisation
Time Frame
At 6, 12 and 18 months
Title
Post-operative pain
Time Frame
At 6 weeks
Title
Medical assessment of scar quality
Time Frame
at 6 weeks and 6, 12, 18 months
Title
Patient self assessment of scar
Time Frame
At 6, 12 and 18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier GALL, PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
12. IPD Sharing Statement
Learn more about this trial
Epidermal Cells Delivery and Acute Burns
We'll reach out to this number within 24 hrs