Trial Outcomes & Findings for Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis (NCT NCT04625426)
NCT ID: NCT04625426
Last Updated: 2021-05-05
Results Overview
Total number of participants who experienced IAD healing
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
Up to seven days from initiation of treatment
Results posted on
2021-05-05
Participant Flow
2 participants initially recruited were found to be not eligible before being assigned to an arm, leading to them being dropped from the study before assignation.
Participant milestones
| Measure |
3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant
Skin cleanser: 3M No-Rinse Cleanser. Skin protectant: 3M Cavilon Advanced Skin Protectant (liquid acrylic tetrapolymer skin protectant layer).
The skin cleanser was used during every episode of incontinence and the protectant was applied every three days as recommended by the manufacturer.
3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant: Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant
|
Conveen EasiCleanse and Conveen Critic Barrier
Skin cleanser: Conveen EasiCleanse. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin cleanser was also first used to cleanse the skin, followed by application of the barrier cream, as per the barrier cream manufacturer's instructions.
Conveen EasiCleanse and Conveen Critic Barrier: Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
|
Soap and Water / Incontinence Wipes and Conveen Critic Barrier
Skin cleanser: Ordinary soap and water or incontinence wipes. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin was cleansed using soap and water or incontinence wipes, followed by application of the barrier cream.
Standard cleansing and Conveen Critic Barrier: Hospital's standard care for IAD management
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
37
|
24
|
|
Overall Study
COMPLETED
|
9
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
14
|
25
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis
Baseline characteristics by cohort
| Measure |
3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant
n=23 Participants
Skin cleanser: 3M No-Rinse Cleanser. Skin protectant: 3M Cavilon Advanced Skin Protectant (liquid acrylic tetrapolymer skin protectant layer).
The skin cleanser was used during every episode of incontinence and the protectant was applied every three days as recommended by the manufacturer.
3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant: Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant
|
Conveen EasiCleanse and Conveen Critic Barrier
n=37 Participants
Skin cleanser: Conveen EasiCleanse. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin cleanser was also first used to cleanse the skin, followed by application of the barrier cream, as per the barrier cream manufacturer's instructions.
Conveen EasiCleanse and Conveen Critic Barrier: Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
|
Soap and Water / Incontinence Wipes and Conveen Critic Barrier
n=24 Participants
Skin cleanser: Ordinary soap and water or incontinence wipes. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin was cleansed using soap and water or incontinence wipes, followed by application of the barrier cream.
Standard cleansing and Conveen Critic Barrier: Hospital's standard care for IAD management
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
77.2 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
80.2 years
STANDARD_DEVIATION 9.56 • n=7 Participants
|
80.7 years
STANDARD_DEVIATION 8.03 • n=5 Participants
|
79.51 years
STANDARD_DEVIATION 9.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
22 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Malay
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Indian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Body Mass Index
|
20.3 kg/m^2
STANDARD_DEVIATION 3.81 • n=5 Participants
|
21.0 kg/m^2
STANDARD_DEVIATION 5.19 • n=7 Participants
|
20.4 kg/m^2
STANDARD_DEVIATION 3.42 • n=5 Participants
|
20.6 kg/m^2
STANDARD_DEVIATION 4.18 • n=4 Participants
|
|
Type of incontinence
Urinary incontinence
|
17 participants
n=5 Participants
|
24 participants
n=7 Participants
|
21 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
Type of incontinence
Faecal incontinence
|
22 participants
n=5 Participants
|
37 participants
n=7 Participants
|
24 participants
n=5 Participants
|
83 participants
n=4 Participants
|
|
Type of incontinence
Dual incontinence
|
16 participants
n=5 Participants
|
24 participants
n=7 Participants
|
21 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Faecal frequency
|
3.25 episodes/day
STANDARD_DEVIATION 1.65 • n=5 Participants
|
3.52 episodes/day
STANDARD_DEVIATION 2.01 • n=7 Participants
|
3.43 episodes/day
STANDARD_DEVIATION 2.31 • n=5 Participants
|
3.43 episodes/day
STANDARD_DEVIATION 2.01 • n=4 Participants
|
|
Presence of indwelling urinary catheter
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Stool consistency
Type 4 (Best Outcome)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Stool consistency
Type 5 (Second-best)
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Stool consistency
Type 6 (Third-best outcome)
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Stool consistency
Type 7 (Worst outcome)
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Stool consistency
Missing
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to seven days from initiation of treatmentTotal number of participants who experienced IAD healing
Outcome measures
| Measure |
3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant
n=23 Participants
Skin cleanser: 3M No-Rinse Cleanser. Skin protectant: 3M Cavilon Advanced Skin Protectant (liquid acrylic tetrapolymer skin protectant layer).
The skin cleanser was used during every episode of incontinence and the protectant was applied every three days as recommended by the manufacturer.
3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant: Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant
|
Conveen EasiCleanse and Conveen Critic Barrier
n=37 Participants
Skin cleanser: Conveen EasiCleanse. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin cleanser was also first used to cleanse the skin, followed by application of the barrier cream, as per the barrier cream manufacturer's instructions.
Conveen EasiCleanse and Conveen Critic Barrier: Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
|
Soap and Water / Incontinence Wipes and Conveen Critic Barrier
n=24 Participants
Skin cleanser: Ordinary soap and water or incontinence wipes. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin was cleansed using soap and water or incontinence wipes, followed by application of the barrier cream.
Standard cleansing and Conveen Critic Barrier: Hospital's standard care for IAD management
|
|---|---|---|---|
|
Number of Participants Who Experienced IAD Healing
Healed
|
8 Participants
|
12 Participants
|
5 Participants
|
|
Number of Participants Who Experienced IAD Healing
Censored
|
15 Participants
|
25 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Up to seven days from initiation of treatmentPercentage of participants who experienced IAD healing
Outcome measures
| Measure |
3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant
n=23 Participants
Skin cleanser: 3M No-Rinse Cleanser. Skin protectant: 3M Cavilon Advanced Skin Protectant (liquid acrylic tetrapolymer skin protectant layer).
The skin cleanser was used during every episode of incontinence and the protectant was applied every three days as recommended by the manufacturer.
3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant: Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant
|
Conveen EasiCleanse and Conveen Critic Barrier
n=37 Participants
Skin cleanser: Conveen EasiCleanse. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin cleanser was also first used to cleanse the skin, followed by application of the barrier cream, as per the barrier cream manufacturer's instructions.
Conveen EasiCleanse and Conveen Critic Barrier: Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
|
Soap and Water / Incontinence Wipes and Conveen Critic Barrier
n=24 Participants
Skin cleanser: Ordinary soap and water or incontinence wipes. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin was cleansed using soap and water or incontinence wipes, followed by application of the barrier cream.
Standard cleansing and Conveen Critic Barrier: Hospital's standard care for IAD management
|
|---|---|---|---|
|
Proportion of Participants With IAD Healing
|
35 percentage of participants
|
32 percentage of participants
|
21 percentage of participants
|
SECONDARY outcome
Timeframe: Up to three days from initiation of treatmentExamination of the development of skin loss using the Ghent Global IAD Categorisation tool (GLOBIAD). Binary scoring, 1 and 2. Higher value (2) indicates worse outcome (Development of skin loss)
Outcome measures
| Measure |
3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant
n=23 Participants
Skin cleanser: 3M No-Rinse Cleanser. Skin protectant: 3M Cavilon Advanced Skin Protectant (liquid acrylic tetrapolymer skin protectant layer).
The skin cleanser was used during every episode of incontinence and the protectant was applied every three days as recommended by the manufacturer.
3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant: Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant
|
Conveen EasiCleanse and Conveen Critic Barrier
n=37 Participants
Skin cleanser: Conveen EasiCleanse. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin cleanser was also first used to cleanse the skin, followed by application of the barrier cream, as per the barrier cream manufacturer's instructions.
Conveen EasiCleanse and Conveen Critic Barrier: Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
|
Soap and Water / Incontinence Wipes and Conveen Critic Barrier
n=24 Participants
Skin cleanser: Ordinary soap and water or incontinence wipes. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin was cleansed using soap and water or incontinence wipes, followed by application of the barrier cream.
Standard cleansing and Conveen Critic Barrier: Hospital's standard care for IAD management
|
|---|---|---|---|
|
Number of Participants Who Developed Skin Loss
|
0 Participants
|
5 Participants
|
3 Participants
|
Adverse Events
3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conveen EasiCleanse and Conveen Critic Barrier
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Soap and Water / Incontinence Wipes and Conveen Critic Barrier
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place