Prevention of Incontinence-associated Dermatitis

Incontinence-associated Dermatitis Clinical Trial

— PID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05403762
• Other study ID #: PID
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: October 2022
• Source: Charite University, Berlin, Germany
• Contact: Jan Kottner, Prof.
• Phone: 0049 30 450 529411
• Email: jan.kottner[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: May 31, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Incontinence-associated Dermatitis

Intervention

Other:
• ESENTA™ 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.
• Hydrophobes 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.

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Short summary of current studies being conducted by the Institute of Clinical Nursing Science at the Charité Universitätsmedizin, Berlin.