Clinical Investigation Exploring a Newly Developed Ostomy Baseplate

Coloplast

Status: Enrolling

Conditions: Stoma Ileostomy

Treatments: Device: Comparator; Device: Incestigational device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07376421

CP383

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Is currently receiving or have within the past 60 days received radio-and/or chemotherapy.
• Low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer.
• Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray treatment.
• Is breastfeeding.
• Is pregnant based on urine pregnancy test.
• Has known hypersensitivity towards any of the investigational devices used in the investigation.
• Has a complicated stoma at baseline, as assessed by investigator (e.g., dehiscence/prolapse/hernia).
• Participates in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and is otherwise complying with the inclusion and exclusion criteria of this protocol.
• Daily use of analgesics, antihistamine or steroid treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Investigational device

Experimental group

Description:

4 weeks treatment with investigational device

Treatment:

Device: Incestigational device

Comparator

Active Comparator group

Description:

4 weeks treatment with investigational device

Treatment:

Device: Comparator