Ileostomy
Conditions
Brief summary
The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.
Detailed description
Six types of patches are tested: Patch 1: Standard adhesive with own feces Patch 2: Standard adhesive with own feces mixture Patch 3: Standard adhesive with simulated feces Patch 4: Standard adhesive with simulated feces mixture Patch 5: Standard adhesive with buffer (control) Patch 6: Standard adhesive with buffer feces mixture (control) Each subject is randomized to one of two arms testing three patches on the peristomal skin (patch 1, 3 and 5 or patch 2, 4 and 6). Furthermore, within each arm an attempt will be made to randomize each of the three patches on the peristomal skin to one of three locations surrounding the stoma (upper left, upper right, lower). On the healthy contralateral abdominal skin the subjects test all six patches. A run in period with 2 subjects (healthy volunteers) was conducted to clarify the length of the test period. They were exposed to 4 patches (patch 3-6) on healthy abdominal skin which was removed at 2 different time slots. Based on the results the test period was established
Interventions
OTHERPatch 1
Patch 1:standard adhesive with own feces in sleeve
OTHERPatch 2
Patch 2:standard adhesive with own feces mixture in sleeve
OTHERPatch 3
Patch 3: standard adhesive with simulated feces in sleeve
OTHERPatch 4
Patch 4:standard adhesive with simulated feces mixture in sleeve
OTHERPatch 5
Patch 5:standard adhesive with buffer in sleeve
OTHERPatch 6
Patch 6:standard adhesive with buffer mixture in sleeve
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have given written informed consent * Be at least 18 years of age and have full legal capacity * Have had an ileostomy for more than one year * Have normal to slightly red skin on the area used in the evaluation * Has an ileostomy with a diameter up to (≤) 35 mm * Have a peristomal area accessible for applied patches (assessed by investigator)
Exclusion criteria
* Currently receiving or have within the past 2 months received radio- and/or chemotherapy * Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment * Are pregnant or breastfeeding * Having dermatological problems in the peristomal- or abdominal area (assessed by investigator) * Participating in other interventional clinical investigations or have previously participated in this investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trans Epidermal Water Loss After Test of Patches. | Approximately 7-10 hours | Trans Epidermal Water Loss is a standardized non-invasive method for describing the barrier function of the skin. Damage to the skin surface (stratum corneum) will lower the barrier of the skin and thereby increase water loss. This can be used as a measure for the damaging effect of the adhesives to the skin. Trans Epidermal Water Loss is measured by applying a probe to the skin surface and is assessed nine times for each patch after applying the patch: three repeated measurements of the skin covered by the center of the patch (Center), as well as three repeated measurements of the skin covered by the adhesive (Under adhesive). |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peristomal Patches: Patch 1, 3 and 5 Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin
Measurements of skin at three locations of each patch: Center and under adhesive.
Patch 1: Patch 1:standard adhesive with own feces in sleeve
Patch 2: Patch 2:standard adhesive with own feces mixture in sleeve
Patch 3: Patch 3: standard adhesive with simulated feces in sleeve
Patch 4: Patch 4:standard adhesive with simulated feces mixture in sleeve
Patch 5: Patch 5:standard adhesive with buffer in sleeve
Patch 6: Patch 6:standard adhesive with buffer mixture in sleeve | 12 |
| Peristomal Patches: Patch 2, 4 and 6 Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.
Patch 1: Patch 1:standard adhesive with own feces in sleeve
Patch 2: Patch 2:standard adhesive with own feces mixture in sleeve
Patch 3: Patch 3: standard adhesive with simulated feces in sleeve
Patch 4: Patch 4:standard adhesive with simulated feces mixture in sleeve
Patch 5: Patch 5:standard adhesive with buffer in sleeve
Patch 6: Patch 6:standard adhesive with buffer mixture in sleeve | 10 |
| Total | 22 |
Baseline characteristics
| Characteristic | Peristomal Patches: Patch 1, 3 and 5 | Peristomal Patches: Patch 2, 4 and 6 | Total |
|---|---|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 12.9 | 64.1 years STANDARD_DEVIATION 5.2 | 63.5 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Trans Epidermal Water Loss After Test of Patches.
Trans Epidermal Water Loss is a standardized non-invasive method for describing the barrier function of the skin. Damage to the skin surface (stratum corneum) will lower the barrier of the skin and thereby increase water loss. This can be used as a measure for the damaging effect of the adhesives to the skin. Trans Epidermal Water Loss is measured by applying a probe to the skin surface and is assessed nine times for each patch after applying the patch: three repeated measurements of the skin covered by the center of the patch (Center), as well as three repeated measurements of the skin covered by the adhesive (Under adhesive).
Time frame: Approximately 7-10 hours
Population: three repeated measurements per participant were performed and used in analysis e.g. 12 participants have 3x12=36 units analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peristomal Skin Patch 1 Center | Trans Epidermal Water Loss After Test of Patches. | 45.8 g/m^2/h | Standard Deviation 29.3 |
| Peristomal Skin Patch 2 Center | Trans Epidermal Water Loss After Test of Patches. | 22.9 g/m^2/h | Standard Deviation 16.4 |
| Peristomal Skin Patch 3 Center | Trans Epidermal Water Loss After Test of Patches. | 36.8 g/m^2/h | Standard Deviation 21.7 |
| Peristomal Skin Patch 4 Center | Trans Epidermal Water Loss After Test of Patches. | 19.6 g/m^2/h | Standard Deviation 11.6 |
| Peristomal Skin Patch 5 Center | Trans Epidermal Water Loss After Test of Patches. | 15.7 g/m^2/h | Standard Deviation 6.9 |
| Peristomal Skin Patch 6 Center | Trans Epidermal Water Loss After Test of Patches. | 13.3 g/m^2/h | Standard Deviation 7.1 |
| Abdominal Skin Patch 1 Center | Trans Epidermal Water Loss After Test of Patches. | 30.1 g/m^2/h | Standard Deviation 25.5 |
| Abdominal Skin Patch 2 Center | Trans Epidermal Water Loss After Test of Patches. | 22.7 g/m^2/h | Standard Deviation 23.1 |
| Abdominal Skin Patch 3 Center | Trans Epidermal Water Loss After Test of Patches. | 31.5 g/m^2/h | Standard Deviation 27.7 |
| Abdominal Skin Patch 4 Center | Trans Epidermal Water Loss After Test of Patches. | 14.5 g/m^2/h | Standard Deviation 12.7 |
| Abdominal Skin Patch 5 Center | Trans Epidermal Water Loss After Test of Patches. | 13.2 g/m^2/h | Standard Deviation 8.7 |
| Abdominal Skin Patch 6 Center | Trans Epidermal Water Loss After Test of Patches. | 12.2 g/m^2/h | Standard Deviation 7.6 |
| Peristomal Skin Patch 1 Under Adhesive | Trans Epidermal Water Loss After Test of Patches. | 19.5 g/m^2/h | Standard Deviation 16.4 |
| Peristomal Skin Patch 2 Under Adhesive | Trans Epidermal Water Loss After Test of Patches. | 12.3 g/m^2/h | Standard Deviation 8.7 |
| Peristomal Skin Patch 3 Under Adhesive | Trans Epidermal Water Loss After Test of Patches. | 14.5 g/m^2/h | Standard Deviation 11.7 |
| Peristomal Skin Patch 4 Under Patch | Trans Epidermal Water Loss After Test of Patches. | 14.7 g/m^2/h | Standard Deviation 7.6 |
| Peristomal Skin Patch 5 Under Adhesive | Trans Epidermal Water Loss After Test of Patches. | 13.8 g/m^2/h | Standard Deviation 8.8 |
| Peristomal Skin Patch 6 Under Patch | Trans Epidermal Water Loss After Test of Patches. | 15.1 g/m^2/h | Standard Deviation 8.1 |
| Abdominal Skin Patch 1 Under Adhesive | Trans Epidermal Water Loss After Test of Patches. | 19.0 g/m^2/h | Standard Deviation 12.7 |
| Abdominal Skin Patch 2 Under Adhesive | Trans Epidermal Water Loss After Test of Patches. | 19.9 g/m^2/h | Standard Deviation 16.5 |
| Abdominal Skin Patch 3 Under Adhesive | Trans Epidermal Water Loss After Test of Patches. | 18.7 g/m^2/h | Standard Deviation 15.4 |
| Abdominal Skin Patch 4 Under Adhesive | Trans Epidermal Water Loss After Test of Patches. | 17.3 g/m^2/h | Standard Deviation 15.1 |
| Abdominal Skin Patch 5 Under Adhesive | Trans Epidermal Water Loss After Test of Patches. | 15.3 g/m^2/h | Standard Deviation 11.1 |
| Abdominal Skin Patch 6 Under Adhesive | Trans Epidermal Water Loss After Test of Patches. | 15.7 g/m^2/h | Standard Deviation 10.4 |