Application of Cultured Autologous Keratinocytes for Burn Wound Healing

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2013-09-30

Brief Summary

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In this study the treatment of full thickness burn wounds with cultured autologous keratinocytes in combination with meshed split skin autograft versus meshed split skin graft alone will be compared. It is expected that the application of cultured autologous keratinocytes in combination with a meshed split skin autograft will improve wound healing and scar formation.

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Detailed Description

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The standard treatment for extensive burn wounds is transplantation with meshed split skin graft. Disadvantages of this treatment are that healing of large full thickness burn wounds is still accompanied by scar formation. Even standard treatment, transplantation with a (meshed) split skin autograft, does not result in satisfactory functional and cosmetic appearance of the healed wound. Due to limited available donor sites meshes needs to be enlarged. Bigger enlargements of meshes give more scarring and mesh pattern are still visible in scars, probably because wound closure still needs several weeks. Application of cultured autologous keratinocytes may enhance wound closure and improve outcome of healing.

Primary objective: Does the application of cultured autologous keratinocytes on deep burn wounds accelerate wound closure Secondary objectives: Does the application of cultured autologous keratinocytes on deep burn wounds improve scar quality with respect to scar elasticity, colour/pigmentation and/or smoothness after 3 and 12 months.

Conditions

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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

wound 1: the placement of keratinocytes onto a collagen/elastin support after the application of the meshed split skin autograft.

Group Type EXPERIMENTAL

Cultured autologous keratinocytes

Intervention Type BIOLOGICAL

The experimental wound site will be covered with cultured keratinocytes on a collagen/elastin carrier after the application of a meshed split skin autograft. The control wound site will be covered with a meshed split skin autograft alone.

2

control wound site; application of mesh graft alone

Group Type OTHER

Cultured autologous keratinocytes

Intervention Type BIOLOGICAL

The experimental wound site will be covered with cultured keratinocytes on a collagen/elastin carrier after the application of a meshed split skin autograft. The control wound site will be covered with a meshed split skin autograft alone.

Interventions

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Cultured autologous keratinocytes

The experimental wound site will be covered with cultured keratinocytes on a collagen/elastin carrier after the application of a meshed split skin autograft. The control wound site will be covered with a meshed split skin autograft alone.

Intervention Type BIOLOGICAL

Other Intervention Names

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Cultured keratinocytes

Eligibility Criteria

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Inclusion Criteria

* Competent and temporarily incompetent patients 18 years of age or older with acute burn wounds that require widely meshed skin grafting, which do not need immediate excision
* Minimal study wound area 100 cm2
* Maximal study wound area 300 cm2
* Maximal TBSA 30% full thickness wounds
* Informed consent

Exclusion Criteria

* Immunocompromised patients
* Infected wounds
* Use of high doses of (.20mg/pd) corticosteroids and/or cytostatica
* Known penicillin allergy
* Conditions where the patient is non compliant as judged by a medical specialist

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No