Epidermal Cells Delivery and Acute Burns (ENSEM)

This study has been terminated.
(Not enough patients included)
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774033

Locations
France
Hopital Trousseau
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Olivier GALL, PH Assistance Publique - Hôpitaux de Paris
  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 October 30, 2014