Incontinence-associated Dermatitis
Conditions
Keywords
Skin care, Long-term care, Nursing home resident, Erythema, Geriatric medicine
Brief summary
Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged direct contact of the skin with urine and/or stool. Elderly and care-dependent people are often affected by this type of inflammation. Gentle skin cleansing and the use of skin protection products are recommended. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. There is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory trial in elderly nursing home residents and geriatric patients will be conducted.
Detailed description
Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged and direct contact of the skin with urine and/or stool. It may occur in all age groups but elderly and care-dependent incontinent people are often affected by this type of inflammation. Promotion of continence, use of absorbent products and structured skin care are recommended to prevent and/or treat IAD. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. Currently, there is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory randomized controlled trial in incontinent elderly nursing home residents and geriatric patients will be conducted. In the two intervention groups, a film-forming or a lipophilic skin protection product will be applied in addition to standardized skin care regimens. Every other day, investigators will perform skin inspections, including instrumental skin measurements to quantify erythema for a total study period of n= 14 days. IAD- related pain and itch will be assessed. A total of n= 210 nursing home residents and geriatric patients in Berlin, Germany, aged over 65 years, who are affected by urinary and faecal incontinence without signs of severe IAD will be included.
Interventions
OTHERESENTA™ Skin Barrier Spray (ConvaTec, UK)
The skin protectant will be applied on clean and dry skin exposed to urine and stool. After application, the solvent evaporates leaving a silicone film on the skin surface.
OTHERHydrophobes Basisgel DAC
The skin protectant will be applied on clean and dry skin. It contains 95% paraffin oil and creates a hydrophobic layer on the skin surface.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Geriatric patients or residents being incontinent of urine and stool * Expected minimum length of stay of 14 days at the care facility * Intact skin with no clinical signs of IAD OR * intact skin with early clinical signs of IAD (IAD category 1A) * Written informed consent
Exclusion criteria
* Residents/patients at the end of life * Residents/Patients with IAD category 1B, 2A, 2B and/or signs of clinical infection in the IAD area * Any skin condition or wounds (at investigational areas of the skin) requiring additional treatment (e. g. pressure ulcers, intertrigo, infection) * Known hypersensitivity or allergy to silicones and/or topical leave-on products * Topical treatments in the IAD area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Incontinence-associated Dermatitis (IAD) | 14 Days | Number of subjects developing IAD of all subjects (cumulative incidence). Classification of IAD according to Ghent Global IAD Categorisation Tool (GLOBIAD) (Category 1A, 1B, 2A, 2B). The GLOBIAD categorises IAD severity based on visual inspection of the affected skin areas. Category 1A: Persistent redness without clinical signs of infection Category 1B: Persistent redness with clinical signs of infection Category 2A: Skin loss without clinical signs of infection Category 2B: Skin loss with clinical signs of infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythema (Instrumental Measurement) | 14 Days | Erythema measured with the Mexameter MX® 18 (Courage + Khazaka, Cologne, Germany). Means of two duplicate measurements per skin area are displayed in arbitrary units (AU) ranging from 0 (= no erythema) to 999 (= extreme erythema). |
| Erythema (Visual Inspection) | 14 Days | Clinical rating of erythema is conducted according to the item 'Redness' of the incontinence-associated dermatitis and its severity (IADS) instrument. The 3-Item-Scale describes 'Redness' as (1) none, (2) pink, (3) red/ bright red. |
| Incidence of Erosion | 14 Days | The presence (no or yes) of erosion is defined according to the latest International League of Dermatological Societies glossary of cutaneous lesions as a loss of either a portion of or the entire epidermis. Number of subjects developing erosions of all subjects (cumulative incidence). |
| Incidence of Maceration | 14 Days | The presence (no or yes) of maceration is defined as the result of prolonged exposure (of the skin) to moisture and causes the skin to soften and breakdown so that the connective fibres can be teased apart and the skin often exhibits a white appearance. Number of subjects developing maceration of all subjects (cumulative incidence). |
| IAD Related Pain | 14 Days | Numeric Rating Scale (NRS) pain score. The NRS ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain severity. The NRS was administered only to participants without cognitive impairment (MMSE ≥24). |
| Incidence of IAD Related Itch | 14 Days | IAD related itch will be reported directly by patients (yes or no). Number of subjects reporting itch of all subjects (cumulative incidence). |
| Presence of Local Intolerances | 14 Days | The presence of local intolerances will be assessed with the following options: (0) None; 1. homogeneous redness with scattered papules; 2. homogeneous redness and homogeneous infiltration 3. homogeneous redness and infiltration with vesicles 4. homogeneous redness and infiltration with coalescing vesicles |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | 14 Days | AEs and SAEs will be documented and reported according to the current regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) Article 2. |
| Incidents and Serious Incidents | 14 Days | Incidents abd serious incidents will be documented according to the definition of the EU regulation 2017/745 MDR Article 2 and reported to the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORJan Kottner, Prof.
Charite University, Berlin, Germany
Participant flow
Recruitment details
The study was conducted in the federal state of Berlin, Germany. Recruitment and study procedures took place in 20 geriatric care units, including two inpatient wards in acute care hospitals and 18 long-term care facilities. Participant recruitment was conducted from August 2022 to January 2025, and follow-up for all study outcomes, including potential harms, was completed in February 2025.
Pre-assignment details
53/220 individuals were excluded before randomisation for the following reasons: * not meeting the inclusion criteria (n = 20; for example, a pre-existing wound at the investigational area), * unavailability at baseline screening (n = 12), * discharge or absence at baseline (n = 7), * terminal condition or death (n = 7), * declined participation (n = 2), * other reasons (n = 5).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 82.4 years STANDARD_DEVIATION 8.4 |
| Barthel Index | 25.4 score STANDARD_DEVIATION 21.1 |
| Body Mass Index (BMI) | 25.2 kg/m2 STANDARD_DEVIATION 6.3 |
| Care level Care level 1 | 1 Participants |
| Care level Care level 2 | 6 Participants |
| Care level Care level 3 | 35 Participants |
| Care level Care level 4 | 25 Participants |
| Care level Care level 5 | 17 Participants |
| Care level None | 2 Participants |
| Care level Unknown | 2 Participants |
| Cognitive Ability MMSE < 24 | 42 Participants |
| Cognitive Ability MMSE ≥ 24 | 12 Participants |
| Diarrhoea | 5 Participants |
| Erythema None | 1 Participants |
| Erythema Pink | 21 Participants |
| Erythema Red/Bright red | 1 Participants |
| Erythema level | 265 AU STANDARD_DEVIATION 91 |
| IAD-related itch | 2 Participants |
| IAD-related pain | 2 Participants |
| Incontinence-Associated Dermatitis (IAD) IAD Category 1A present | 8 Participants |
| Incontinence-Associated Dermatitis (IAD) No IAD | 49 Participants |
| Location of IAD 1A Back | 4 Participants |
| Location of IAD 1A Both | 1 Participants |
| Location of IAD 1A Front | 5 Participants |
| Maceration Back | 3 Participants |
| Maceration Front | 0 Participants |
| Maceration None | 18 Participants |
| Main Medical Diagnoses Dementia | 26 Participants |
| Main Medical Diagnoses Diabetes mellitus | 13 Participants |
| Main Medical Diagnoses Heart arrhythmia | 16 Participants |
| Main Medical Diagnoses Hypertension | 34 Participants |
| Main Medical Diagnoses Renal failure | 23 Participants |
| Mini-Mental State Examination (MMSE) | 9.3 scores on a scale STANDARD_DEVIATION 10.7 |
| Race and Ethnicity Not Collected | 0 Participants |
| Satisfaction | 7.3 score STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 15 Participants |
| Urinary tract infection | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 57 | 0 / 53 |
| other Total, other adverse events | 0 / 57 | 0 / 57 | 0 / 53 |
| serious Total, serious adverse events | 0 / 57 | 0 / 57 | 0 / 53 |
Outcome results
None listed