Clinical trial NCT01616043: Glyaderm Clinical Evaluation Multicenter Study
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Full-thickness Skin Loss Due to Burn, Unspecified Site
Keywords: scar quality
Lead sponsor: Euro Tissue Bank
Sponsor class: OTHER
Collaborators: name: Dutch Burns Foundation
First posted: 2012-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: scar quality
timeFrame: 12 months after wound closure
Secondary outcomes:
measure: percentage of Glyaderm take
timeFrame: before autograft application (5-7 days after Glyaderm application)
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Hospital Network Antwerp - site Stuivenberg
city: Brussel
country: Belgium
facility: Militairy Hospital neder over heembeek
city: Gent
country: Belgium
facility: Ghent University Hospital (B)
city: Athens
country: Greece
facility: General Hospital of Athens "G. Gennimatas" (GR)
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: UZ Gent, Belgium
name: Ali Pirayesh, MD
role: PRINCIPAL_INVESTIGATOR
References: