An interventional study of Ostomy device 1 and Ostomy device 2 in Ileostomy - Stoma, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Basic science
This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.
Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
Device: Ostomy device 1
In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film
Device: Ostomy device 2
In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
Device: Ostomy device 3
This device consists of a known adhesive and a new top film
This device consists of a new adhesive and a known top film
This device consists of a known adhesive and a new top film
Trans Epidermal Water Loss
The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m\^2/h).
Time frame: 7 days
| Milestone | Ostomy Device 1 | Ostomy Device 2 | Ostomy Device 3 |
|---|---|---|---|
| Started | 13 | 15 | 10 |
| Completed | 13 | 15 | 10 |
| Not completed | 0 | 0 | 0 |
The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m\^2/h).
| g/m^2/h | Ostomy Device 1 | Ostomy Device 2 | Ostomy Device 3 |
|---|---|---|---|
| Trans Epidermal Water Loss | 19.6 (15.5 to 24.9) | 20.7 (16.6 to 25.8) | 24.1 (18.2 to 31.8) |
Collected over 42 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ostomy Device 1 | 0/13 (0%) | 0/13 (0%) | 2/13 (15.4%) |
| Ostomy Device 2 | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| Ostomy Device 3 | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Event | Ostomy Device 1 | Ostomy Device 2 | Ostomy Device 3 |
|---|---|---|---|
| Peristomal skin complicationsSkin and subcutaneous tissue disorders | 2/13 | 1/15 | 1/10 |
| Age, Continuous(years) | Ostomy Device 1 | Ostomy Device 2 | Ostomy Device 3 | Total |
|---|---|---|---|---|
| Mean | 70.1 ± 6.4 | 70.1 ± 7.7 | 63.6 ± 13 | 68.4 ± 9.2 |
| Sex: Female, Male(Participants) | Ostomy Device 1 | Ostomy Device 2 | Ostomy Device 3 | Total |
|---|---|---|---|---|
| Female | 2 | 2 | 3 | 7 |
| Male | 11 | 13 | 7 | 31 |
| Race and Ethnicity Not Collected(Participants) | Ostomy Device 1 | Ostomy Device 2 | Ostomy Device 3 | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Ostomy Device 1 | Ostomy Device 2 | Ostomy Device 3 | Total |
|---|---|---|---|---|
| Denmark | 13 | 15 | 10 | 38 |
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Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Coloplast A/S