Neotherix are pleased to announce a major milestone in the development of EktoTherix™ Tissue Repair Scaffold: a First in Man clinical investigation is currently open for recruitment and the first patients have been recruited. This initial safety study will assess EktoTherix in the treatment of full-thickness, dermatologic wounds created by the surgical removal of non-melanoma skin cancers. Up to fifteen patients will be recruited across two sites in the York Teaching Hospital NHS Foundation Trust: The York Hospital and Scarborough Hospital.
The Investigation will assess outcomes following the application of EktoTherix Tissue Repair Scaffold to wounds resulting from these surgical excisions. The scaffold is expected to help the patients' own cells repair the wound, enhancing healing and improving quality of repair. The tissue scaffold is designed to be completely absorbed by the body during the healing process so that there is no need to remove it when the wound is healed.
Although the primary objective is to assess the safety of EktoTherix in humans, a secondary objective is to evaluate its clinical performance. Our hypothesis is that use of EktoTherix will increase incidence of complete healing and result in an overall better cosmetic result (cosmesis) of the healed wound.
For more information on the study see the EktoTherix study record on ClinicalTrials.gov .