Pilotstudie 08.06

Background
OTR4120 is a heparan sulfate mimetic that optimizes the regeneration of injured tissues by sequestering growth factors in the extracellular matrix. From multiple animal studies it is known that OTR4120 application to wounds improves tissue regeneration both in speed of healing and in improved tissue architecture.

Objective(s)
To demonstrate the efficacy of a novel matrix therapy based technology that creates improved wound healing in a clinical donor site model.

Methods
In a double blinded, placebo controlled clinical pilot trial on burn victims, OTR4120 will be tested in improving tissue healing. In order to warrant wound standardization, donor sites are used as they represent clean, standardized wounds of a controlled depth.

Directly following skin harvesting, the donor sites of 19 patients will be subdivided in 3 sections. The proximal section will receive OTR4120 or placebo, the middle section will be left untreated and the distal section will receive OTR4120 or placebo. OTR4120/placebo will be administered via a soaked compress that will be placed on the wound for 5 minutes. Subsequently, the compress will be discarded and standard treatment protocols will be followed.

The primary outcome measurement will be the percentage of wound closure at day 7 after skin harvest.

Anticipated results
We expect OTR4120 to enhance the wound closure rate by at least 25% as it will modulate the early events of healing process. If this pilot trial runs succesfully, an extended trial on burn wounds will be formulated where OTR4120 is expected to control inflammation and enhance tissue regeneration thereby limiting burn-induced skin alterations that lead to hypertrophic scars.