UPM Biomedicals’ innovative wound dressing FibDex is undergoing a clinical investigation of performance and safety in patients with superficial dermal burns. The clinical investigation will be conducted by the Burn Centre of Uppsala University Hospital, Sweden, and is estimated to be completed in the beginning of the year 2025.
UPM Biomedicals has previously prepared all the required protocols and other documents and received the regulatory and ethical approvals. The clinical investigation has started with Fredrik Huss (MD, PhD, Assoc. Professor) as the principal investigator and is enrolling patients since May 2023.
“Cellulose-based dressings have quickly become our go-to-dressing for superficial dermal burns. The main advantage of this type of dressing is that once it has been applied it sticks to the wound surface while the skin heals and the subsequent outer dressing changes becomes much less painful” says Fredrik Huss, Director of the Burn Centre of Uppsala University Hospital.
The prospective, randomized, open-label, within-patient controlled, non-inferiority clinical investigation of the nanofibrillar cellulose (NFC) wound dressing FibDex for treatment of superficial dermal burns will be done on up to 30 paediatric and adult patients. The clinical performance and safety of FibDex will be compared with best practice for this this type of wounds in terms of healing time and patient treatment outcome. Each patient will be closely monitored during the treatment and all outcomes recorded electronically.
Johana Kuncova-Kallio, director of UPM Biomedicals, commented, “We are delighted to collaborate with Assoc. Prof. Huss in this clinical investigation aimed at extending the indication of our FibDex wound dressing for the treatment of burn patients. In the current global context of nursing shortages, our product has the potential to significantly reduce nursing time per patient, as the total time for dressing changes could be reduced.”
UPM Biomedicals’ patented, CE-marked FibDex wound dressing (NB0044) has been designed to provide support for effective wound healing and to deliver improved patient outcome. Thus far the intended purpose for FibDex has been skin graft donor site wounds. One-time applicable FibDex nanocellulose wound dressing maintains an optimal moisture balance for wound healing and detaches itself after epithelization.
FibDex is porous, breathable, and highly biocompatible with cells and tissues. Clinical investigations using FibDex have reported efficient wound healing and epithelization, significant improvement in skin elasticity and POSAS results for scar appearance, as well as low pain experience.
At the core of FibDex’ unique properties is wood-based nanocellulose, which is a sustainable choice without animal, bacterial or human-origin components.
UPM Biomedicals makes products for life science and clinical uses based on its patented nanofibrillar cellulose technology from birch wood pulp, and clinical products are manufactured under ISO 13485 quality management system.
SOURCE: UPM Biomedicals