CP376 OCT Exploratory Skin Study

Coloplast

Status: Completed

Conditions: Stoma Ileostomy

Treatments: Device: flat 1-piece open ostomy device

Study type: Interventional

Funder types: Industry

Identifiers

NCT06965140

CP376

Details and patient eligibility

About

An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled.

The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period .The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.

Full description

An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT)

12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled. Subjects will use their standard of care ostomy device as intended and remove the device at the test visit.

The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period when the OCT scan and other skin measurements has been completed. The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.

The OCT scans and other skin measurements (TEWL, Hydration and Erythema measurements) will be performed on the skin when the ostomy device has been removed.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has given written informed consent
2. Is at least 18 years old
3. Has full legal capacity
4. Has an ileostomy
5. Is using a flat 1-piece open ostomy device
6. Have had the ileostomy for a year

Exclusion criteria

1. Is currently receiving or have within the past two months received radio-and/or chemotherapy
2. Is currently receiving or have within the past month received steroid treatment in the skin area used in the investigation, e.g. lotion, spray, injection or tablet
3. Is pregnant or breastfeeding

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

OCT scan + skin measurements abdominal and peristomal skin

Other group

Description:

OCT scan + skin measurements abdominal and peristomal skin

Treatment:

Device: flat 1-piece open ostomy device