Testing the Protective and Caring Effect of a Water-in-oil Formulation in Patients Suffering From Urinary and/or Fecal Incontinence and Requiring Incontinence Care Products
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Protective Balm.
- Who it may be relevant to
- Registry conditions: Incontinence, Urinary, Incontinence, Fecal. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Non-controlled, Exploratory, Single-arm Clinical Study With a Water-in-oil Emulsion to Test the Protecting and Caring Effect of the Formulation on 'Incontinence-care Product Requiring' Fecal and/or Urinary Incontinent Patients
Overview
The aim of this study is to test the protecting and caring effect of a protective balm on patients suffering from urinary and/or fecal incontinence and need incontinence care products.
Detailed description
Patients receive at least two applications of the test product in the application area daily for two weeks. An additional washing product is used during the entire application time. The caring and skin protecting effects, the skin tolerability and cosmetic efficacy of the test product will be assessed by a physician, a nurse and the patient.
Interventions
- Other Protective Balm
The test product will be applied in addition to an additional washing product in the test area.
Primary outcome measures
- Assessment of skin tolerability (single parameters) by the physician regarding erythema, oedema, dryness, papules or pustules [Time frame: Day 1 vs Day 15±2 (after 2 weeks of test product application)]
- Global assessment of tolerability by the phyisician [Time frame: Day 15 ±2 (after 2 weeks of test product application)]
- Global assessment of cosmetic efficacy by the physician [Time frame: Day 15 ±2 (after 2 weeks of test product application)]
- Assessment of skin condition by a nurse [Time frame: Day 1 and Day 15 ±2 (after 2 weeks of test product application)]
- Assessment of product characteristics by a nurse [Time frame: Day 15 ±2 (after 2 weeks of test product application)]
- Global assessment of the product by a nurse [Time frame: Day 15 ±2 (after 2 weeks of test product application)]
- Assessment of product characteristics [Time frame: Day 15 ±2 (after 2 weeks of test product application)]
- Assessment of skin tolerability by the patient [Time frame: Day 15 ±2 (after 2 weeks of test product application)]
Eligibility criteria
Inclusion criteria
- Patient is capable of understanding the information given to them and providing informed consent
- 70 years of age and older
- Patients with incontinence (fecal and/or urinary), requiring incontinence protection material
- Skin type on Fitzpatrick scale: Between I to IV
Exclusion criteria
- Current cancer treatment such as chemotherapy, irradiation
- Documented allergies to skin care and / or skin cleansing products
- Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
- Incontinence-associated dermatitis (IAD) stage >1a
- Active skin disease at the test area
- Any topical medication at the test area within the last 3 days prior to the start of the study and / or hroughout te entire course of the study
- Mini-Mental-Status-Test (MMST) < 20
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Germany · 1 center
- Klinikum Dortmund — Dortmund
Identifiers
NCT: NCT06924502 · GLS-02/2024