Epidermal Cells Delivery and Acute Burns

NCT ID: NCT00774033

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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

Conditions

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Burn

Keywords

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Keratinocytes Cell spray Deep partial thickness burns Full thickness burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

autologous epidermal cells harvesting kits

Intervention Type DEVICE

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

2

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

Group Type ACTIVE_COMPARATOR

classic skin grafts

Intervention Type PROCEDURE

classic skin grafts used for the treatment of acute burn

Interventions

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autologous epidermal cells harvesting kits

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

Intervention Type DEVICE

classic skin grafts

classic skin grafts used for the treatment of acute burn

Intervention Type PROCEDURE

Other Intervention Names

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Recell®

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier GALL, PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital Trousseau

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P070307

Identifier Type: -

Identifier Source: org_study_id