Application of Cultured Autologous Keratinocytes for Burn Wound Healing

Burns Clinical Trial

— KC  

Official title:

Application of Cultured Autologous Keratinocytes in Combination With a Meshed Split Skin Autograft for Burn Wound Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832156
• Other study ID #: NBS 07.116 KC
• Secondary ID: NL19048.000.07
• Status: Completed
• Phase: Phase 3
• Start date: June 2008
• Est. completion date: September 2013

Study information

• Verified date: June 2014
• Source: Association of Dutch Burn Centres
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Netherlands	Red Cross Hospital	Beverwijk	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Association of Dutch Burn Centres

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary end point is the percentage of wound closure.		7 days
Secondary	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