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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
The test product will be applied in addition to an additional washing product in the test area.
Klinikum Dortmund
Dortmund, Germany
RECRUITINGAssessment of skin tolerability (single parameters) by the physician regarding erythema, oedema, dryness, papules or pustules
Single parameters (erythema, oedema, dryness, papules or pustules) will be assessed by a scale.
Time frame: Day 1 vs Day 15±2 (after 2 weeks of test product application)
Global assessment of tolerability by the phyisician
The physician will evaluate the global skin tolerability, according to a scale (taking results of skin tolerability (single parameters), and his or her personal assessment of tolerability at all time points into account).
Time frame: Day 15 ±2 (after 2 weeks of test product application)
Global assessment of cosmetic efficacy by the physician
The physician will evaluate the global efficacy, according to a scale.
Time frame: Day 15 ±2 (after 2 weeks of test product application)
Assessment of skin condition by a nurse
The skin condition (color, turgor and surface of the skin) will be assessed by binary queries (yes/no). The caring and protecting status of the skin will be assessed by an Visual Analogue Scale (VAS).
Time frame: Day 1 and Day 15 ±2 (after 2 weeks of test product application)
Assessment of product characteristics by a nurse
Product characteristics regarding scent, spreadability, removability, appearance of the skin (redness, dryness) will be assessed by a questionnaire with predefined answer options.
Time frame: Day 15 ±2 (after 2 weeks of test product application)
Global assessment of the product by a nurse
The nurse will evaluate the global assessment of the product, according to a scale (taking results of the skin condition regarding the caring and protecting status and the product characteristics into account).
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Time frame: Day 15 ±2 (after 2 weeks of test product application)
Assessment of product characteristics
Product characteristics will be assessed by the patient in a questionnaire regarding sensation during application of the product by the nurse (feeling during application on the skin).
Time frame: Day 15 ±2 (after 2 weeks of test product application)
Assessment of skin tolerability by the patient
The overall subjective skin status after application of the test product will be evaluated summarized for the whole application period according to a scale (each parameter (itching, burning, stinging, pain, soreness) separately).
Time frame: Day 15 ±2 (after 2 weeks of test product application)