Epidermal Cells Delivery and Acute Burns (ENSEM)

July 25, 2012 updated by: Assistance Publique - Hôpitaux de Paris

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

The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Hopital Trousseau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.
Time Frame: at 1, 2 and 6 weeks
at 1, 2 and 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Medical costs at complete epithelialisation
Time Frame: At 6, 12 and 18 months
At 6, 12 and 18 months
Post-operative pain
Time Frame: At 6 weeks
At 6 weeks
Medical assessment of scar quality
Time Frame: at 6 weeks and 6, 12, 18 months
at 6 weeks and 6, 12, 18 months
Patient self assessment of scar
Time Frame: At 6, 12 and 18 months
At 6, 12 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Olivier GALL, PH, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 15, 2008

First Submitted That Met QC Criteria

October 15, 2008

First Posted (Estimate)

October 16, 2008

Study Record Updates

Last Update Posted (Estimate)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P070307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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