Aim
This phase 1 clinical trial will demonstrate the safety and efficacy of a new bioactive dressing designed to prevent scarring of skin burns.
Background
Scarring impacts many patients by reducing movement of the limbs and causing psychological problems.Fundamentally, a hypertrophic scar results from the overproduction and poor organisation of collagen by fibroblasts during wound healing, which in turn inhibits wound closure. This process is driven by increasing levels of the cell-signalling molecule, Transforming Growth Factor β1 (TGF-β1) following injury. Decorin is a small proteoglycan and functions within wound healing by binding to and dampening TGF-β1 and facilitates organisation of new collagen. We have developed a dressing containing a synthetic version of decorin, called Galacorin, designed to help prevent scar formation in skin. The dressing exhibits viscoelastic properties like normal skin, is drapable on an irregular wound bed with minimal dead space left and is semi-permeable. This avoids the accumulation of tissue fluid that is the leading cause of infection. The dressing is transparent, allowing the burn to be visually assessed whilst it is in-place, and does not adhere to the wound’s surface, allowing for easy removal.
In the lab, decorin delivered from our wound dressing can significantly reduce scar formation. A manufacturing process has been developed enabling the dressing to be robustly produced in large quantities so that it could be turned into a medical product for use in the clinic. This product will help to improve the quality of life of many patients injured in ways that would normally result in scarring.
Method
This is a phase 1 clinical trial which is designed to establish the safety of new products in a limited number of patients in a highly controlled hospital environment. This dressing trial will be with 20 patients admitted to hospital with skin burns and will demonstrate the safety and efficacy of the dressing for burns patients. Recruitment will begin in 2022. The trial will look at whether it improves the burn’s healing time and reduces scarring, when compared to the current standard of care dressing, Mepitel One. If successful, this project will pave the way for a phase 2 multi-centre clinical trial.
