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Novel Device for Improving Ostomy Skin Condition

Periodic Reporting for period 1 - OSTOFORM (Novel Device for Improving Ostomy Skin Condition)

Período documentado: 2019-04-01 hasta 2020-03-31

Skin complications are a common problem among people living with a stoma. The main cause of skin complication is from stoma output leaking onto the surrounding skin. Once somebody has an ostomy skin complication, they must continually place an ostomy bag onto broken, damaged skin. Because the landing site for the ostomy bag is damaged, the bag might not stick properly, causing further leaks, meaning that the skin does not have a chance to heal. Also, this can result in an increased risk of the ostomy pouch falling off, so it has a major impact on quality of life.

Ostoform, through the H2020 SME Instrument, is developing a novel solution to help prevent stoma output from contacting the user’s skin – The Ostoform Seal with FLOWASSIST Protection. The solution uses a combination of absorbent and non-absorbent materials to direct the flow of stoma output into the ostomy pouch, thus keeping the user’s skin healthy and improving the quality of life for people who use an ostomy pouch.

Through the H2020 project, Ostoform will conduct a user trial and build on its data to demonstrate the safety and efficacy of the new device. By the end of the project, the design and manufacturing method will be finalised, and distributors will be identified for device commercialisation.
Ostoform has already completed a multi-site clinical investigation, which has demonstrated a clear trend towards improvements in skin condition, and very encouraging user-feedback. This study has been accepted for publication in the scientific journal Advances in Skin and Wound Care. Furthermore, bench testing has demonstrated the safety of the novel device, and testing to comparator products has shown that the Ostoform Seal lasts longer than other products in the market when exposed to fluids. This information will prove valuable when the Company submits applications for device reimbursement in various countries. The device is now patented in Europe and the design is being finalised, with transfer to manufacturing expected to occur on-schedule.
By the end of the project, Ostoform will have developed a method to manufacture the Ostoform Seal at high-volume and will have identified distributors to partner with in device commercialisation. The company will have begun to submit reimbursement applications, and will have robust marketing material, demonstrating the benefits of the innovative device.
Ostoform Seal with FLOWASSIST Protection