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Brief Title: EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
Official Title: EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
Study ID: NCT02409628
Brief Summary: The purpose of study is to assess the safety and performance of EktoTherix™ Tissue Repair Scaffold in the treatment of full-thickness, dermatologic wounds created by the surgical removal of non-melanoma skin cancers. EktoTherix™ is a medical device developed by Neotherix Limited, manufactured by the polymer processing technique of electrospinning. Described as a "tissue scaffold", EktoTherix is placed into the surgical wound to help the patients' own cells repair the wound, enhancing healing and improving quality (including cosmetic outcome). The tissue scaffold is completely absorbed by the body during the healing process, which means that there is no need to remove it when the wound is healed. All patients recruited into this study are treated with EktoTherix, are seen weekly until they heal and seen again at the final follow-up visit three months post-surgery. The investigators hypothesise that the use of EktoTherix will increase incidence of complete healing and result in an overall better cosmetic result of the healed wound.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, North Yorkshire, United Kingdom
Scarborough Hospital, York Teaching Hospital NHS Foundation Trust, Scarborough, North Yorkshire, United Kingdom
The York Hospital, York Teaching Hospital NHS Foundation Trust, York, North Yorkshire, United Kingdom
Name: Calum C Lyon, BSc BA MA MB BChir MRCP FRCP
Affiliation: York Teaching Hospital NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR
Name: Michael J Raxworthy, BSc PhD MBA
Affiliation: Neotherix Limited
Role: STUDY_DIRECTOR