Trial Outcomes & Findings for Prevention of Incontinence-associated Dermatitis (NCT NCT05403762)
NCT ID: NCT05403762
Last Updated: 2026-03-18
Results Overview
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
COMPLETED
NA
220 participants
14 Days
2026-03-18
Participant Flow
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.
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).
Participant milestones
| Measure |
ESENTA™ Skin Barrier Spray
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.
|
Hydrophobes Basisgel DAC
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.
|
Standard Care
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
53
|
|
Overall Study
Per-protocol
|
53
|
49
|
53
|
|
Overall Study
COMPLETED
|
57
|
57
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ESENTA™ Skin Barrier Spray
n=57 Participants
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.
|
Hydrophobes Basisgel DAC
n=57 Participants
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.
|
Standard Care
n=53 Participants
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
82.8 years
STANDARD_DEVIATION 7.5 • n=57 Participants
|
82.0 years
STANDARD_DEVIATION 9.6 • n=57 Participants
|
82.5 years
STANDARD_DEVIATION 8.1 • n=53 Participants
|
82.4 years
STANDARD_DEVIATION 8.4 • n=167 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=57 Participants
|
41 Participants
n=57 Participants
|
38 Participants
n=53 Participants
|
121 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=57 Participants
|
16 Participants
n=57 Participants
|
15 Participants
n=53 Participants
|
46 Participants
n=167 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
25.2 kg/m2
STANDARD_DEVIATION 6.3 • n=57 Participants
|
24.8 kg/m2
STANDARD_DEVIATION 5.2 • n=57 Participants
|
24.7 kg/m2
STANDARD_DEVIATION 6.3 • n=53 Participants
|
24.9 kg/m2
STANDARD_DEVIATION 5.9 • n=167 Participants
|
|
Care level
None
|
2 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
2 Participants
n=53 Participants
|
4 Participants
n=167 Participants
|
|
Care level
Care level 1
|
0 Participants
n=57 Participants
|
1 Participants
n=57 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=167 Participants
|
|
Care level
Care level 2
|
2 Participants
n=57 Participants
|
5 Participants
n=57 Participants
|
6 Participants
n=53 Participants
|
13 Participants
n=167 Participants
|
|
Care level
Care level 3
|
19 Participants
n=57 Participants
|
7 Participants
n=57 Participants
|
9 Participants
n=53 Participants
|
35 Participants
n=167 Participants
|
|
Care level
Care level 4
|
21 Participants
n=57 Participants
|
25 Participants
n=57 Participants
|
20 Participants
n=53 Participants
|
66 Participants
n=167 Participants
|
|
Location of IAD 1A
Front
|
4 Participants
n=9 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
1 Participants
n=8 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
0 Participants
n=7 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
5 Participants
n=24 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
|
Care level
Care level 5
|
10 Participants
n=57 Participants
|
17 Participants
n=57 Participants
|
14 Participants
n=53 Participants
|
41 Participants
n=167 Participants
|
|
Care level
Unknown
|
3 Participants
n=57 Participants
|
2 Participants
n=57 Participants
|
2 Participants
n=53 Participants
|
7 Participants
n=167 Participants
|
|
Main Medical Diagnoses
Hypertension
|
34 Participants
n=57 Participants
|
32 Participants
n=57 Participants
|
34 Participants
n=53 Participants
|
100 Participants
n=167 Participants
|
|
Main Medical Diagnoses
Dementia
|
24 Participants
n=57 Participants
|
35 Participants
n=57 Participants
|
26 Participants
n=53 Participants
|
85 Participants
n=167 Participants
|
|
Main Medical Diagnoses
Renal failure
|
20 Participants
n=57 Participants
|
23 Participants
n=57 Participants
|
17 Participants
n=53 Participants
|
60 Participants
n=167 Participants
|
|
Main Medical Diagnoses
Diabetes mellitus
|
15 Participants
n=57 Participants
|
13 Participants
n=57 Participants
|
16 Participants
n=53 Participants
|
44 Participants
n=167 Participants
|
|
Main Medical Diagnoses
Heart arrhythmia
|
17 Participants
n=57 Participants
|
16 Participants
n=57 Participants
|
16 Participants
n=53 Participants
|
49 Participants
n=167 Participants
|
|
Diarrhoea
|
1 Participants
n=57 Participants
|
3 Participants
n=57 Participants
|
1 Participants
n=53 Participants
|
5 Participants
n=167 Participants
|
|
Urinary tract infection
|
3 Participants
n=57 Participants
|
5 Participants
n=57 Participants
|
1 Participants
n=53 Participants
|
9 Participants
n=167 Participants
|
|
Mini-Mental State Examination (MMSE)
|
10.3 scores on a scale
STANDARD_DEVIATION 11.0 • n=57 Participants
|
8.3 scores on a scale
STANDARD_DEVIATION 10.4 • n=57 Participants
|
9.6 scores on a scale
STANDARD_DEVIATION 10.7 • n=53 Participants
|
9.3 scores on a scale
STANDARD_DEVIATION 10.7 • n=167 Participants
|
|
Cognitive Ability
MMSE ≥ 24
|
15 Participants
n=57 Participants
|
10 Participants
n=57 Participants
|
12 Participants
n=53 Participants
|
37 Participants
n=167 Participants
|
|
Cognitive Ability
MMSE < 24
|
42 Participants
n=57 Participants
|
47 Participants
n=57 Participants
|
41 Participants
n=53 Participants
|
130 Participants
n=167 Participants
|
|
Barthel Index
|
25.4 score
STANDARD_DEVIATION 21.1 • n=57 Participants
|
20.2 score
STANDARD_DEVIATION 19.1 • n=57 Participants
|
21.8 score
STANDARD_DEVIATION 18.5 • n=53 Participants
|
22.5 score
STANDARD_DEVIATION 19.6 • n=167 Participants
|
|
Incontinence-Associated Dermatitis (IAD)
No IAD
|
48 Participants
n=57 Participants
|
49 Participants
n=57 Participants
|
46 Participants
n=53 Participants
|
143 Participants
n=167 Participants
|
|
Incontinence-Associated Dermatitis (IAD)
IAD Category 1A present
|
9 Participants
n=57 Participants
|
8 Participants
n=57 Participants
|
7 Participants
n=53 Participants
|
24 Participants
n=167 Participants
|
|
Location of IAD 1A
Back
|
4 Participants
n=9 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
6 Participants
n=8 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
7 Participants
n=7 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
17 Participants
n=24 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
|
Location of IAD 1A
Both
|
1 Participants
n=9 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
1 Participants
n=8 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
0 Participants
n=7 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
2 Participants
n=24 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
|
Erythema
Pink
|
9 Participants
n=9 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
6 Participants
n=8 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
6 Participants
n=7 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
21 Participants
n=24 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
|
Erythema
Red/Bright red
|
0 Participants
n=9 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
1 Participants
n=8 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
0 Participants
n=7 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
1 Participants
n=24 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
|
Erythema
None
|
0 Participants
n=9 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
1 Participants
n=8 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
1 Participants
n=7 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
2 Participants
n=24 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
|
Maceration
Front
|
0 Participants
n=9 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
1 Participants
n=8 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
0 Participants
n=7 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
1 Participants
n=24 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
|
Maceration
Back
|
1 Participants
n=9 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
3 Participants
n=8 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
1 Participants
n=7 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
5 Participants
n=24 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
|
Maceration
None
|
8 Participants
n=9 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
4 Participants
n=8 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
6 Participants
n=7 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
18 Participants
n=24 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
|
IAD-related itch
|
1 Participants
n=9 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
1 Participants
n=8 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
0 Participants
n=7 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
2 Participants
n=24 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
|
IAD-related pain
|
0 Participants
n=9 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
2 Participants
n=8 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
0 Participants
n=7 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
2 Participants
n=24 Participants • This row includes only participants with IAD category 1A at baseline (24/167); therefore, the numbers reflect a subgroup of the total study population rather than the full sample.
|
|
Erythema level
|
255 AU
STANDARD_DEVIATION 93.0 • n=57 Participants
|
266 AU
STANDARD_DEVIATION 87.0 • n=57 Participants
|
275 AU
STANDARD_DEVIATION 92.0 • n=53 Participants
|
265 AU
STANDARD_DEVIATION 91.0 • n=167 Participants
|
|
Satisfaction
|
7.3 score
STANDARD_DEVIATION 1.6 • n=57 Participants
|
6.9 score
STANDARD_DEVIATION 1.7 • n=57 Participants
|
7.6 score
STANDARD_DEVIATION 1.6 • n=53 Participants
|
7.3 score
STANDARD_DEVIATION 1.6 • n=167 Participants
|
PRIMARY outcome
Timeframe: 14 DaysPopulation: Denominators vary because outcome-specific at-risk populations were defined by baseline IAD status. Participants with IAD category 2 at baseline were excluded from the study. Incidence of IAD 2A/2B is based on all enrolled participants (n=167). Incidence of IAD 1 or 2 (n=143) excludes those with IAD 1A at baseline. Other rows are restricted to baseline-defined subgroups (no IAD or IAD 1A).
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
Outcome measures
| Measure |
ESENTA™ Skin Barrier Spray
n=57 Participants
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.
|
Hydrophobes Basisgel DAC
n=57 Participants
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.
|
Standard Care
n=53 Participants
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
|---|---|---|---|
|
Incidence of Incontinence-associated Dermatitis (IAD)
Incidence IAD 1 and/or 2
|
18 Participants
|
8 Participants
|
5 Participants
|
|
Incidence of Incontinence-associated Dermatitis (IAD)
Incidence IAD 2A/B
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Incidence of Incontinence-associated Dermatitis (IAD)
No IAD at baseline → IAD 1A/B
|
15 Participants
|
6 Participants
|
5 Participants
|
|
Incidence of Incontinence-associated Dermatitis (IAD)
No IAD at baseline → IAD 2A/B
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Incontinence-associated Dermatitis (IAD)
IAD 1A at baseline → IAD 2A/B
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Incidence of Incontinence-associated Dermatitis (IAD)
IAD 1A at baseline → no IAD
|
7 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Participant numbers vary across study days because instrumental erythema measurements were analyzed per visit based on available data. At some visits, assessments were not possible for individual participants (e.g., temporary absence or medical reasons), but measurements were performed again at subsequent scheduled visits. Therefore, denominators may decrease or increase between days and reflect available observations at each time point rather than the total study population.
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).
Outcome measures
| Measure |
ESENTA™ Skin Barrier Spray
n=57 Participants
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.
|
Hydrophobes Basisgel DAC
n=57 Participants
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.
|
Standard Care
n=53 Participants
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
|---|---|---|---|
|
Erythema (Instrumental Measurement)
Day 2
|
258 AU
Standard Deviation 108.0
|
266 AU
Standard Deviation 88.2
|
267 AU
Standard Deviation 96.0
|
|
Erythema (Instrumental Measurement)
Day 4
|
248 AU
Standard Deviation 95.8
|
286 AU
Standard Deviation 107.0
|
254 AU
Standard Deviation 99.8
|
|
Erythema (Instrumental Measurement)
Day 6
|
261 AU
Standard Deviation 115.0
|
288 AU
Standard Deviation 107.0
|
277 AU
Standard Deviation 94.9
|
|
Erythema (Instrumental Measurement)
Day 8
|
267 AU
Standard Deviation 86.5
|
288 AU
Standard Deviation 87.9
|
281 AU
Standard Deviation 97.2
|
|
Erythema (Instrumental Measurement)
Day 10
|
265 AU
Standard Deviation 101.0
|
276 AU
Standard Deviation 91.2
|
255 AU
Standard Deviation 119.0
|
|
Erythema (Instrumental Measurement)
Day 12
|
273 AU
Standard Deviation 103.0
|
278 AU
Standard Deviation 79.4
|
280 AU
Standard Deviation 101.0
|
|
Erythema (Instrumental Measurement)
Day 14
|
288 AU
Standard Deviation 108.0
|
272 AU
Standard Deviation 82.8
|
277 AU
Standard Deviation 99.8
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Rows include only participants with IAD at the respective follow-up visit, as erythema was assessed as an IAD-related sign. Therefore, denominators differ from the total study population and reflect only those with present IAD at that time point.
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.
Outcome measures
| Measure |
ESENTA™ Skin Barrier Spray
n=8 Participants
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.
|
Hydrophobes Basisgel DAC
n=7 Participants
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.
|
Standard Care
n=5 Participants
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
|---|---|---|---|
|
Erythema (Visual Inspection)
Day 14 · Pink
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Erythema (Visual Inspection)
Day 6 · Pink
|
7 Participants
|
6 Participants
|
5 Participants
|
|
Erythema (Visual Inspection)
Day 6 · Red/Bright Red
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Erythema (Visual Inspection)
Day 14 · Red/Bright Red
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: These rows include only participants with IAD at the respective follow-up visit, as erosion was assessed as an IAD-related skin sign. Therefore, denominators differ from the total study population and reflect only those with present IAD at that time point.
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).
Outcome measures
| Measure |
ESENTA™ Skin Barrier Spray
n=8 Participants
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.
|
Hydrophobes Basisgel DAC
n=7 Participants
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.
|
Standard Care
n=5 Participants
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
|---|---|---|---|
|
Incidence of Erosion
Day 6
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Erosion
Day 14
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Rows include only participants with IAD at the respective follow-up visit, as maceration was assessed as an IAD-related skin sign. Therefore, denominators differ from the total study population and reflect only those with present IAD at that time point.
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).
Outcome measures
| Measure |
ESENTA™ Skin Barrier Spray
n=8 Participants
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.
|
Hydrophobes Basisgel DAC
n=7 Participants
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.
|
Standard Care
n=5 Participants
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
|---|---|---|---|
|
Incidence of Maceration
Day 6
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Incidence of Maceration
Day 14
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Only participants without cognitive impairment (MMSE ≥24) were eligible for assessment using the Numeric Rating Scale (NRS). At Day 6, 2 of 20 participants with IAD met this criterion; at Day 14, 3 of 8 participants with IAD met this criterion. Therefore, denominators differ from the total study population and vary by follow-up visit.
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).
Outcome measures
| Measure |
ESENTA™ Skin Barrier Spray
n=1 Participants
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.
|
Hydrophobes Basisgel DAC
n=2 Participants
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.
|
Standard Care
n=1 Participants
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
|---|---|---|---|
|
IAD Related Pain
Day 14
|
0.0 scores on a scale
Standard Deviation 0.0
|
1.5 scores on a scale
Standard Deviation 2.1
|
—
|
|
IAD Related Pain
Day 6
|
0.0 scores on a scale
Standard Deviation 0.0
|
—
|
0.0 scores on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Rows include only participants with IAD at the respective follow-up visit, as itch was assessed as an IAD-related symptom. Therefore, denominators differ from the total study population and reflect only those with present IAD at that time point.
IAD related itch will be reported directly by patients (yes or no). Number of subjects reporting itch of all subjects (cumulative incidence).
Outcome measures
| Measure |
ESENTA™ Skin Barrier Spray
n=8 Participants
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.
|
Hydrophobes Basisgel DAC
n=7 Participants
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.
|
Standard Care
n=5 Participants
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
|---|---|---|---|
|
Incidence of IAD Related Itch
Day 6
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of IAD Related Itch
Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: No adverse events (AEs) or serious adverse events (SAEs) occurred during the study. Safety monitoring was performed throughout the trial, and all scheduled assessments confirmed the absence of AEs and SAEs; therefore, all entries are zero.
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
Outcome measures
| Measure |
ESENTA™ Skin Barrier Spray
n=57 Participants
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.
|
Hydrophobes Basisgel DAC
n=57 Participants
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.
|
Standard Care
n=53 Participants
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
|---|---|---|---|
|
Presence of Local Intolerances
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 DaysAEs 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.
Outcome measures
| Measure |
ESENTA™ Skin Barrier Spray
n=57 Participants
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.
|
Hydrophobes Basisgel DAC
n=57 Participants
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.
|
Standard Care
n=53 Participants
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
|---|---|---|---|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 DaysIncidents 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).
Outcome measures
| Measure |
ESENTA™ Skin Barrier Spray
n=57 Participants
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.
|
Hydrophobes Basisgel DAC
n=57 Participants
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.
|
Standard Care
n=53 Participants
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
|
|---|---|---|---|
|
Incidents and Serious Incidents
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
ESENTA™ Skin Barrier Spray
Hydrophobes Basisgel DAC
Standard Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Dr. Jan Kottner
Charité - Universitätsmedizin Berlin
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place