Incontinence-associated Dermatitis
Conditions
Keywords
"skin barrier" "absorbing incontinence product" elderly
Brief summary
The main aim of this study is to describe the effects of dry or wet incontinence pad material on the skin barrier function by measuring the changes of the stratum corneum on healthy participants due to the application of pads with varying wetness level to the forearm. Study findings have relevance for product development of absorbing incontinence products to further protect the skin from the damaging effects of excess moisture. Participants are subject to baseline measures of TEWL, SH, pH and water profile. Dry or wet pads are then added to the forearm skin and worn for two hours. After a recovery period, the SSWL, SH and water profile is measured. The study is conducted over a single 4h visit. As this is an explorative study no hypothesis is intended to be tested.
Interventions
DEVICETest patches
Patches (incontinence product cut outs) either dry, 50% saturated with water or 100% saturated with water applied to the forearm and worn for 2 hours
Sponsors
Essity Hygiene and Health AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Healthy volunteers get dry or wet test patches applied to the skin of the forearms. The cut outs are either dry or wetted with saline to 50% or 100% capacity. In total two pads are applied per forearm.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Men and women ≥ 65 years. 2. Mentally and physically able to participate in this study. 3. Written informed consent to participate in this study. 4. Intact skin on the volar forearms without skin irritation.
Exclusion criteria
1. Have any known allergies or intolerances to one or several components of the absorbing incontinence product. 2. Suffer from excessive sweating, hyperhidrosis. 3. Have any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator. 4. Not be of childbearing potential. 5. Have an alcohol and/or drug dependency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Trans Epidermal Water loss (TEWL) | 2 hours | TEWL is measured at baseline and then after 2h of dry patch use the unit is g/m2\*h. For the wet patches the follow up measurement is on skin surface water loss (SSWL) as the skin is not dry the unit is the same as for TEWL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin hydration | 2 hours | Skin hydration (SH) as measured with moisture meter instrument under the test and control patches. Measure in arbitrary units (a.u). |
| Change in skin surface pH | 2 hours | The pH change under the dry/wet patches are measured and compared. |
| Change skin water profile | 2 hours | As measured Confocal raman microspectrometry. The water content (mass-% water) of skin at different depths is measured and compared for the skin under wet/dry patches. |
Countries
Sweden
Outcome results
None listed