Full-thickness Skin Loss Due to Burn, Unspecified Site Clinical Trial
Official title:
Clinical Application of GLYADERM. A Multicentre, Prospective, Randomized Controlled, Comparative Trial of Glyaderm and Split Thickness Skin Graft Versus Split Thickness Skin Graft Alone in Full Thickness Skin Defects
The healing of full thickness skin defects treated with a split thickness skin graft (STSG)
is frequently associated with excessive scarring and contraction. The psychological burden
of poor cosmesis of these scarred regions as well as functional problems due to skin
tightness and decreased joint mobility cause a very significant morbidity in these patients.
Application of a dermal substitute underneath the split skin may improve the quality of the
scar. Glyaderm is a dermal substitute derived from human skin and due to the elastin in this
substitute it will contribute to a long term improvement of pliability and function and a
better esthetic outcome.
The main objective is to evaluate the difference in scar quality, after skin restoration of
full thickness defects treated with Glyaderm® and STSG versus STSG alone. Secondary
objectives are: to evaluate the percentage of Glyaderm® take before application of
autografts, to compare healing time and percentage of autograft survival and bacterial load
in full thickness defects treated with Glyaderm® and STSG versus STSG alone, and to conduct
a concurrent cost-effectiveness and health related quality of life study (i.e. cost utility
analysis).
The study is an interventional, prospective, randomized and controlled interactive web
based, study in a multicentre setting. Patients with full thickness burn wounds or full
thickness skin defects will be evaluated before enrolment. A total of 120 patients will be
included.
All included patients will undergo full thickness removal of the burned skin or adequate
debridement of all necrotic tissue. The wounds of the patients will be covered with glycerol
preserved allografts for wound bed preparation. At the second operation, 5-7 days after the
first operation, the allografts are removed. If the wound bed is not suitable for grafting,
additional wound bed preparation with allografts is required until the wound bed is
satisfactory. If the wound bed is suitable for grafting, the patient is randomized to the
Glyaderm® group or the control group. The wounds of the patients randomized to the Glyaderm®
group are covered with Glyaderm®. After 6-8 days the wounds are finally covered with a thin
STSG. In the control group, the wounds are immediately covered with a thin STSG.
Up to one year after complete wound closure, patients are followed-up for scar evaluation
and quality of life.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment