Application of cultured autologous keratinocytes in combination with a meshed split skin autograft for burn wound healing

Background
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.
Limited donorsite availability in combination with large wound areas can make
it necessary to use widely meshed grafts or to use the Meek-Wall technique.
Bigger enlargements of meshes give more scarring, probably because wound
closure still needs several weeks. Application of cultured keratinocytes could
enhance wound closure.
In an animal study we demonstrated that the application of cultured
keratinocytes seeded on a carrier indeed enhanced wound closure.

Objective
Evaluation of the application of cultured autologous keratinocytes in
combination with a meshed split skin autograft to improve burn wound healing

Study method
After an intitial trial period to fine tune the protocol, a prospective,
multicentre, randomised trail will be carried out in which an intra-patient
comparisson will be made of the effect of treatment with cultured autologous
keratinocytes in combination with split skin autograft, and split skin graft
alone in adult patients with acute fullthickness burn wounds.
The keratinocytes will be isolated from a biopsy obtained from unaffected skin
(3 cm2) and cultured to increase the cell numbers. The expanded keratinocytes
will be seeded on a collagen carrier and transplanted onto the enlarged
autograft after debridement of the wound, approximately 2 weeks after the
biopsy was taken.
Wound healing is monitored during normal dressing changes. Primary outcome
measure is percentage of wound closure after 7 days (measured by planimetry)

Within the first few day after admission to the burn centre a biopsy (approx. 3
cm2) is taken from the unaffected skin and taken to the lab for the culture of
the keratinocytes. After two weeks the patient will be operated, and both
wounds will be transplanted with a meshed split skin autograft. One wound/wound
area (randomly assigned) will subsequently be cover with the carrier containing
the cultured autologous keratinocytes.

An extra wound is created to obtain healthy skin for keratinocyte culture. The
biopsy as taken under anaesthetics and the wound is sutured. The pain will be
combated with pain relievers (which the patient most probably receive anyhow)
and possible bacterial infection will be treated with antibiotics.
The evaluation of the wounds and scars will take more time especially the
outpatient follow-up at 3 and 12 months. This will take approximately 30
minutes more than usual.
A possible risk will be intolerance or an allergic reaction to one of the
tissue culture ingredient. The carrier is rinsed in saline prior to the
application to remove the culture medium.
We anticipate that the experimental treatment results in improved wound healing
with better cosmetic and functional properties. This even might lead to less
secondary reconstructive surgery.