EktoTherix Tissue Repair Scaffold - EKT01
Research type
Research Study
Full title
EktoTherix Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
IRAS ID
165806
Contact name
Lorenzo Pio Serino
Contact email
Sponsor organisation
Neotherix Limited
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
The main objective of this study is to demonstrate the safety and performance of a new medical device known as EktoTherix™ Tissue Repair Scaffold, when used for the treatment of wounds created by the surgical removal of non-melanoma skin cancers.
EktoTherix™ is a new material developed by Neotherix Limited, described as a "tissue scaffold", that will be 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 will be completely absorbed by the body during the healing process, which means that there is no need to remove it from the wound when the wound is healed.
Our aim for this product is not only to help wounds heal, but also to improve the quality of repair. It is likely that there will also be advantages to patients and health professionals in terms of fewer dressing changes required, meaning that the patients’ wounds will be disturbed less during the healing process.
The study will recruit suitable adult patients with non-melanoma skin cancer for whom the chosen therapeutic option is surgical excision followed by healing of the wound by secondary intention (i.e. the wound is not fully closed by suturing). Participants will be selected from patients attending clinics at The York Hospital and Scarborough Hospital.
Following treatment with EktoTherix™, the patients will be monitored for three months.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
14/WM/1263
Date of REC Opinion
27 Jan 2015
REC opinion
Further Information Favourable Opinion