NCT00774033

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 26, 2012

Status Verified

March 1, 2012

Enrollment Period

3.2 years

First QC Date

October 15, 2008

Last Update Submit

July 25, 2012

Conditions

Burn

Keywords

KeratinocytesCell sprayDeep partial thickness burnsFull thickness burns

Outcome Measures

Primary Outcomes (1)

  • 80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.

    at 1, 2 and 6 weeks

Secondary Outcomes (4)

  • Medical costs at complete epithelialisation

    At 6, 12 and 18 months

  • Post-operative pain

    At 6 weeks

  • Medical assessment of scar quality

    at 6 weeks and 6, 12, 18 months

  • Patient self assessment of scar

    At 6, 12 and 18 months

Study Arms (2)

1

EXPERIMENTAL

Treatment of acute burn in adults and children by epidermal cell spray

Device: autologous epidermal cells harvesting kits

2

ACTIVE COMPARATOR

Treatment of acute burn in adults and children by classic skin grafts

Procedure: classic skin grafts

Interventions

autologous epidermal cells harvesting kitsDEVICE

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

Also known as: Recell®
1
classic skin graftsPROCEDURE

classic skin grafts used for the treatment of acute burn

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Thermal burns requiring surgical debridement
  • Area involved \< 1260cm²

You may not qualify if:

  • local or systemic infection
  • conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)
  • hypersensitivity to trypsin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Trousseau

Paris, 75012, France

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Olivier GALL, PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 16, 2008

Study Start

December 1, 2008

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

July 26, 2012

Record last verified: 2012-03

Locations

FR(1)