Clinical trial NCT00832156: Application of Cultured Autologous Keratinocytes for Burn Wound Healing
Official title: Application of Cultured Autologous Keratinocytes in Combination With a Meshed Split Skin Autograft for Burn Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burns
Keywords: Burns
Cultured autologous keratinocytes
Wound healing
Wound closure
Scar quality
Lead sponsor: Association of Dutch Burn Centres
Sponsor class: OTHER
First posted: 2009-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary end point is the percentage of wound closure.
timeFrame: 7 days
Secondary outcomes:
measure: Secondary objective is scar quality (i.e. subjective scar assessment, scar elasticity, colour and pigmentation of the scar and smoothness of the scar surface).
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Beverwijk
country: Netherlands
facility: Red Cross Hospital
state: Noord-Holland
Study officials:
affiliation: Association of Dutch Burn Centers
name: E Middelkoop, Prof
role: STUDY_DIRECTOR
References: