Application of Cultured Autologous Keratinocytes for Burn Wound Healing

Phase 3

Completed

• Conditions: Burns
• Interventions: Biological: Cultured autologous keratinocytes

• Registration Number: NCT00832156
• Lead Sponsor: Association of Dutch Burn Centres

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Primary Completion: 2012-09
• Study Completion: 2013-09
• Status Verified: 2014-06
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cultured autologous keratinocytes	wound 1: the placement of keratinocytes onto a collagen/elastin support after the application of the meshed split skin autograft.
2	Cultured autologous keratinocytes	control wound site; application of mesh graft alone

Primary Outcome Measures

Name	Time	Method
Primary end point is the percentage of wound closure.	7 days

Secondary Outcome Measures

Name	Time	Method
Secondary objective is scar quality (i.e. subjective scar assessment, scar elasticity, colour and pigmentation of the scar and smoothness of the scar surface).	3 and 12 months

Trial Locations

Locations (1)

Red Cross Hospital; 🇳🇱 Beverwijk, Noord-Holland, Netherlands