ong-term safety and effectiveness evaluation of participants treated with NovoSorb® Biodegradable Temporising Matrix (BTM) for dermal repair: An observational cohort study

Various dermal substitutes exist and assist the management of patients where the full skin layer has been damaged/lost. They provide temporary wound closure and provide a scaffold for creation of a “neodermis” prior to final wound closure. NovoSorb BTM is a fully synthetic, biodegradable porous polyurethane foam surgical implant that provides temporary wound cover and a support for cells growth to help a wound heal. The study aim was to evaluate long-term safety and effectiveness of BTM in patients previously treated with BTM in wounds of at least 5% total body surface area with at least 1 device implanted. 15 patients were recruited who had BTM applied at least 18 months prior to the study. The injuries were primarily full thickness burns with patients aged 26-80 years and 13 were male. All patients underwent a standardised Physical examination and assessment of long-term scar quality for each BTM-treated lesion. Results demonstrated long-term safety and effectiveness of BTM in the treatment of adults with dermal injuries. No new long-term safety concerns were identified with no long-term risks detected. The results provide evidence that BTM can successfully integrate into the wound bed and provide a neodermis to support wound closure with good quality scar healing in the long term. Limitations of this study include a small number of patients, study delays from COVID-19 pandemic, the patient population was predominately male, Caucasian with full thickness burn injury.