Epidermal Cells Delivery and Acute Burns | NCT00774033

Studies
Epidermal Cells Delivery and Acute Burns

NCT00774033

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Terminated

Last Update Posted

Jul 26, 2012Estimated

Enrollment

51Actual

Phase

Phase 3

Conditions

Burn

Interventions

autologous epidermal cells harvesting kits
classic skin grafts

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not enough patients included

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Feb 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Oct 15, 2008

First Submission Date that Met QC Criteria

Oct 15, 2008

First Posted Date

Oct 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2012

Last Update Posted Date

Jul 26, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
autologous epidermal cells harvesting kits	Device	autologous epidermal cells harvesting kits used for the treatment of acute burn	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier GALL, PH	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Trousseau		Paris		75012	France