Prevention of Incontinence-associated Dermatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Two Skin Protection Regimes for the Prevention of Incontinence-associated Dermatitis in Geriatric Care: an Exploratory Trial (PID)

Conditions
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Incontinence-associated Dermatitis

Intervention / Treatment
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* Other: ESENTA™ Skin Barrier Spray (ConvaTec, UK)
* Other: Hydrophobes Basisgel DAC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESENTA™ Skin Barrier Spray<br>In the intervention group I, standardized mild skin cleansing regimen and daily topical application of a film-forming skin protectant at the exposed skin areas will be applied by nursing staff. | Other: ESENTA™ Skin Barrier Spray (ConvaTec, UK)<br>* 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.<br>* Other names: Film-forming skin protectant;|
| Experimental: Hydrophobes Basisgel DAC<br>In the intervention group II, standardized mild skin cleansing regimen and daily topical application of a hydrophobic skin protectant at the exposed skin areas will be applied by nursing staff. | Other: Hydrophobes Basisgel DAC<br>* 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.<br>* Other names: Hydrophobic skin protectant;|
| No Intervention: Standard Care<br>In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of incontinence-associated dermatitis (IAD) | 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 | 14 Days | 
| Erythema | 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). | 14 Days | 
| Erythema | 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. | 14 Days | 
| Incidence of erosion | 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). | 14 Days | 
| Incidence of maceration | 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). | 14 Days | 
| IAD related pain | To assess pain, a Numeric Rating Scale (NRS) is applied. That scale ranges from 0 (= no pain) to 10 (= worst possible pain) for patients/residents without cognitive impairment (according to Mini-Mental-State-Examination (MMSE) with scores of 24 or higher). | 14 Days | 
| Patient satisfaction | To assess patient satisfaction, a Numeric Rating Scale (NRS) is applied.That scale ranges from 0 (= dissatisfied) to 10 (= very satisfied) for patients/residents without cognitive impairment (according to Mini-Mental-State-Examination (MMSE) with scores of 24 or higher). | 14 Days | 
| Incidence of IAD related itch | IAD related itch will be reported directly by patients (yes or no). Number of subjects reporting itch of all subjects (cumulative incidence). | 14 Days | 
| Presence of local intolerances | The presence of local intolerances will be assessed with the following options: (0) None; homogeneous redness with scattered papules; homogeneous redness and homogeneous infiltration homogeneous redness and infiltration with vesicles homogeneous redness and infiltration with coalescing vesicles | 14 Days | 
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | 14 Days | 
| Incidents and serious incidents | 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). | 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin care, Long-term care, Nursing home resident, Erythema, Geriatric medicine