Clinical Investigation Exploring a Newly Developed Ostomy Baseplate
Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, which affect their quality of life negatively. Among the main reasons for developing PSCs are that the peristomal skin is exposed to stomal output either due to leakage of output under the baseplate and/or imperfect cutting of the hole in the baseplate, and incorrect application creating a gap between the hole in the baseplate and the stoma. To seal this gap, Coloplast has developed a new ostomy baseplate and the aim of the investigation is to explore the investigational device 's ability to help protect the peristomal skin.
• Has given written consent
• Is at least 18 years of age
• Has full legal capacity
• Has an ileostomy with consistent liquid fecal output (6-7 Bristol scale).
• Has used flat 1- or 2-piece SenSura Mio, SenSura or Assura Coloplast products for at least 14 days prior to inclusion.
• Has had the stoma for at least 90 days.
• Has a stoma size less than 40mm in diameter
• Has experienced leakage under the baseplate at least three times within the last 14 days.
• Leakage defined as output/seeping under the baseplate (see Appendix A)
• Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last 14 days.
• Has suitable peristomal skin area (assessed by investigator)
• Is able to handle the electronic diary (questionnaire/photo) themselves. If needed, a trained spouse or caretaker is allowed to assist.
• Is able to handle (apply, remove, etc.) the investigational devices themselves.
• Understands that any supporting products under the baseplate are not permissible during the investigation (except for adhesive removers) and is willing to not use these during the investigation.
• Is willing and suitable (determined by the Principal Investigator or designee) to use a flat 2-piece device during the investigation.
• Is willing to change the baseplate at least every third/fourth day during the investigation.