L24
Conditions
Interventions
Group 1: Intervention Group 1
- Total study duration: 14 days
- n= 70 study participants, distributed between two centres: nursing home and geriatric patients (35 men and 35 women)
- Intervention by
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Presence of faecal and urinary incontinence. (2) expected length of stay of at least 14 days (3) intact skin in the study area or intact skin with first clinical signs of IAD (category 1A) (4) Written informed consent of the study participant (or legal representative)
Exclusion criteria
Exclusion criteria: (1) Residents/patients at the end of life (2) Residents/Patients with IAD category 1B, 2A, 2B and/or signs of clinical infection in the IAD area (3) Any skin condition or wounds (at investigational areas of the skin) requiring additional treatment (e. g. pressure ulcers, intertrigo, infection) (4) Known hypersensitivity or allergy to silicones and/or products to stay at the skin (5) Topical treatments in the IAD area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Assessment of IAD on days 0,2,4,6,8,10,12,14 according to GLOBIAD classification (no IAD/IAD 1A/IAD 1B/ IAD 2A/IAD 2B) presented as number of subjects developing an IAD of all subjects (cumulative incidence) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Visual assessment of skin redness: ordinal (no erythema/pink erythema/bright red or red erythema): IADS (incontinence-associated dermatitis and it's severity) instrument - Measurement of skin redness (erythema measurement) in AU (mean of two consecutive measurements): Mexameter® MX18 - presence of erosion (day 0,2,4,6,8,10,12,14): dichotomous (yes/no); presented as number of subjects developing eroded skin of all subjects (cumulative incidence) - presence of maceration (day 0,2,4,6,8,10,12,14): dichotomous (yes/no); presented as number of subjects developingmacerated skin of all subjects (cumulative incidence) - IAD-related pain (day 0,2,4,6,8,10,12,14) - numeric rating scale: NRS (1-10) - Pain Assessment in Advanced Dementia: PAINAD-G scale for patients with a MMSE 24) - Patient safety (day 0,2,4,6,8,10,12,14) - presence of developed intolerances: ordinal, 5 gradations (no/homogeneous redness with scattered papules/homogeneous redness with infiltration/homogeneous redness and infiltration with vesicles/homogeneous redness and infiltration with coalescing vesicles) - Adverse Events (AEs): according to EU Regulation 2017/745 Medical Device Regulation (MDR) Article 2. - Serious Adverse Events (SAEs): according to EU Regulation 2017/745 MDR Article 2 - Incidents: according to EU Regulation 2017/745 MDR Article 2 - Serious Incidents: according to EU Regulation 2017/745 MDR Article 2 | — |
Countries
Germany
Contacts
Public ContactJan Kottner
Charité Campus Charité Mitte
Outcome results
None listed