Neotherix are pleased to announce that the First in Man clinical investigation of EktoTherix Tissue Repair Scaffold has recruited twelve participants. Recruitment is now closed and the clinical data collected from all participants are undergoing 100% source data verification prior to statistical analysis.
This initial safety study has assessed EktoTherix for the treatment of full-thickness, dermatologic wounds created by the surgical removal of non-melanoma skin cancers. Study outcomes following the application of EktoTherix Tissue Repair Scaffold to these excisional wounds were recorded. The scaffold is expected to promote repair of the wound by the patients' own cells, enhancing healing and improving quality of repair. EktoTherix is designed to be completely resorbed by the body during the healing process so there is no need for removal when the wound has healed.
The primary objective of this current study was to assess the safety of EktoTherix in humans with a secondary objective to evaluate its clinical performance. Our hypothesis is that use of EktoTherix will increase incidence of complete and problem-free 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 .