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.
| Status | Terminated |
| Enrollment | 40 |
| Est. completion date | November 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All clearly full thickness burns or skin defects (TBSA Full Thickness Burn < 30%) as clinically evaluated by two plastic surgeons and/or specialist burn surgeons - Possibility to follow the complete treatment schedule until final graft take and subsequently wound healing and finally participation in the follow-up schedule - Informed consent has been obtained. Exclusion Criteria: - All partial thickness burns that can heal by conservative treatment - TBSA > 30 % - Study wound < 100 cm² or > 800 cm² - Age of the patient < 18 year - No follow-up until wound closure or withdrawal before start of follow-up - Patient has any condition(s) that seriously compromises the patient's ability to complete this study. - Patient has participated in another study utilizing an investigational drug within the previous 30 days - Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this study - No informed consent before start of the trial |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Hospital Network Antwerp - site Stuivenberg | Antwerp | |
| Belgium | Militairy Hospital neder over heembeek | Brussel | |
| Belgium | Ghent University Hospital (B) | Gent | |
| Greece | General Hospital of Athens "G. Gennimatas" (GR) | Athens | |
| Netherlands | Maasstad Ziekenhuis | Rotterdam | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Euro Tissue Bank | Dutch Burns Foundation |
Belgium, Greece, Netherlands, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | scar quality | The quality of the scar is measured with objective tools and subjective scar scacles. The elasticity of the scar is measured with the Cutometer® MPA 850 (Courage & Khazaka electronic GmbH) Adapted Vancouver Scar Scale, Patient and Observer Scar Assessment Scale, Ghent contour scale, Tewameter TM 300 for trans epidermal water loss, Corneometer CM 825 for hydration of the stratum corneum, Mexameter MX 18 for erythema and melanin, Reviscometer RVM 600 for the direction of collagen and elastin in the skin Finally a total score is defined. | 12 months after wound closure | No |
| Secondary | percentage of Glyaderm take | 1. visual assessment of Glyaderm ingrowth | before autograft application (5-7 days after Glyaderm application) | No |