Epidermal Cells Delivery and Acute Burns (ENSEM)
This study has been terminated.
(Not enough patients included)
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00774033
First received: October 15, 2008
Last updated: July 25, 2012
Last verified: March 2012
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Purpose
The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns
| Condition | Intervention | Phase |
|---|---|---|
|
Burn |
Device: autologous epidermal cells harvesting kits Procedure: classic skin grafts |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- 80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks. [ Time Frame: at 1, 2 and 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Medical costs at complete epithelialisation [ Time Frame: At 6, 12 and 18 months ] [ Designated as safety issue: No ]
- Post-operative pain [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
- Medical assessment of scar quality [ Time Frame: at 6 weeks and 6, 12, 18 months ] [ Designated as safety issue: No ]
- Patient self assessment of scar [ Time Frame: At 6, 12 and 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | December 2008 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Treatment of acute burn in adults and children by epidermal cell spray
|
Device: autologous epidermal cells harvesting kits
autologous epidermal cells harvesting kits used for the treatment of acute burn
Other Name: Recell®
|
|
Active Comparator: 2
Treatment of acute burn in adults and children by classic skin grafts
|
Procedure: classic skin grafts
classic skin grafts used for the treatment of acute burn
Other Name: classic skin grafts
|
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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00774033 History of Changes |
| Other Study ID Numbers: | P070307 |
| Study First Received: | October 15, 2008 |
| Last Updated: | July 25, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Keratinocytes Cell spray Deep partial thickness burns Full thickness burns |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013