Work package 6
Clinical evaluation of the wound dressing materials generated by HEALiX will commence following the rigorous safety and efficacy testing performed within work package 5. A series of randomized controlled trials will be designed and performed at four different locations in Sweden. This approach enables the project to include patients suffering from a large range of wounds, from serious burns, to acute wounds resulting from traumatic injuries, as well as non-healing wounds which frequently exhibit infection and other conditions that impair healing. By aggregating the results from these clinical trials, indications for the various specific properties of the advanced wound dressing materials can be generated. We expect the clinical trials to define the treatment algorithm for a wide array of wound types and conditions.
All clinical trials will be performed under ethical permission from the governing authority and will conform to the act 2003:460 and statute 2003:615 concerning research involving humans. Studies will also adhere to the act 2002:297 regulating bio banks and registers, as well as the General Data Protection Regulation (GDPR) EU 2016/679. All clinical trial protocols will adhere to current harmonized standards, and will be registered at clinicaltrials.gov.