Application of Cultured Autologous Keratinocytes for Burn Wound Healing (KC)

Association of Dutch Burn Centres

Status and phase: Completed; Phase 3

Conditions: Burns

Treatments: Biological: Cultured autologous keratinocytes

Study type: Interventional

Funder types: Other

Identifiers

NCT00832156

NL19048.000.07

NBS 07.116 KC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Biological: Cultured autologous keratinocytes

2

Other group

Description:

control wound site; application of mesh graft alone

Treatment:

Biological: Cultured autologous keratinocytes