Clinical Application of a Dermal Substitute based on glycerol
preserved Allograft: GLYADERM®
A multicentre, prospective, controlled, randomized, comparative
trial of Glyaderm® and split thickness skin graft versus split
thickness skin graft alone in full thickness skin defects

Rationale:
The healing of full thickness skin defects that are treated with a split
thickness skin graft (STSG), is frequently associated with excessive scarring
and contraction.
The psychological burden of sometimes extremely 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. The most
commonly used dermal substitute Integra has proven to be efficacious in early
clinical trials but lacks elastin which is an important constituent of dermis
and enhances its pliability and function. The long term benefit of the use of
Integra® and the susceptibility to infection makes its use somewhat
controversial and operator dependant. Integra® and other dermal substitutes are
highly commercialized products which harbours great costs and for that reason
often not affordable for a lot of patients. We think that Glyaderm® will have
at least the same advantages as Integra 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. Due to a lower price it should be
affordable for all burn patients.

Objective:
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).

This will be an interventional, prospective, randomized and controlled
interactive web based, study in a multicentre setting.

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.

The burden for the patients participating in this study consist of extra
operations for patients, two in the index group and one in the control group.
These extra operations however will be done as much as possible in combination
with regular operations for other wounds by selection of patients with multiple
wounds needing skin grafts. Extra burden post surgery is represented by the
fact that patients entering this study will be evaluated more extensively
during the inpatient period and outpatient follow up visits at 1,6 and 12
months after wound healing. This will take approximately 3 hours of their time
in total. Additional risks related to this study are the normal risks for a
surgical procedure as performed for any other burn patient needing skin grafts.