Neotherix are pleased to announce the addition of a third site to the First in Man clinical investigation of EktoTherix™ Tissue Repair Scaffold. James Cook University Hospital (South Tees Hospitals NHS Foundation Trust) commenced participation on 25 July, and the clinical team there have already recruited one additional patient to the study.
The addition of James Cook University Hospital supports the work of the two original sites, York Hospital and Scarborough Hospital (both York Teaching Hospital NHS Foundation Trust), and is expected to significantly enhance the rate of patient recruitment to the study.
As reported previously, this initial safety study assesses 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 wounds resulting from these surgical excisions are recorded. The scaffold is expected to promote repair of the wound by the patients' own cells, enhancing healing and improving quality of repair. The tissue scaffold is designed to be completely resorbed by the body during the healing process so that there is no need for removal when the wound has healed.
Although the primary objective is to assess the safety of EktoTherix in humans, a secondary objective is to evaluate its clinical performance. The ability of EktoTherix to increase incidence of complete healing and result in an overall better cosmetic result (cosmesis) of the healed wound will be monitored.
For more information on the study see the EktoTherix study record on ClinicalTrials.gov .