Incontinence-associated Dermatitis
Conditions
Brief summary
The aim of this study is to evaluate the efficacy of two different skin care regimens (3M Cavilon Advanced Skin Protectant with 3M No-Rinse Cleanser and Coloplast Conveen Critic Barrier with Easi-Cleanser) against standard care (Skin wipes and Conveen Critic Barrier) in the management of Incontinence-Associated Dermatitis (IAD) in hospitalised patients
Detailed description
The aim of this study is to evaluate the efficacy of two different skin care regimens (3M Cavilon Advanced Skin Protectant with 3M No-Rinse Cleanser and Coloplast Conveen Critic Barrier with Easi-Cleanser) against standard care (Skin wipes and Conveen Critic Barrier) in the management of Incontinence-Associated Dermatitis (IAD) in hospitalised patients. To date, there is no conclusive evidence on the best treatment for patients presenting with IAD. This has led to current clinical practices tend to select IAD products based on its cost and availability, which can be heavily influenced by marketing and commercialisation efforts. This study allows investigation of the effectiveness of IAD products to ensure the provision of optimal care.
Interventions
DEVICE3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant
Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant
DEVICEConveen EasiCleanse and Conveen Critic Barrier
Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
DEVICEStandard cleansing and Conveen Critic Barrier
Hospital's standard care for IAD management
Sponsors
Tan Tock Seng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Cluster randomised trial
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 21 years and above at point of recruitment * Diagnosed with IAD * At regular risk of exposure to urine and faeces over their hospitalization
Exclusion criteria
* Having a known allergy to the treatment products * Haemodynamically unstable at point of assessment for study * Unable to tolerate lateral positioning for skin cleansing and treatment application * Pregnancy * Having an existing skin disease at point of study that might lead to inaccurate IAD assessment, such as herpes or scabies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced IAD Healing | Up to seven days from initiation of treatment | Total number of participants who experienced IAD healing |
| Proportion of Participants With IAD Healing | Up to seven days from initiation of treatment | Percentage of participants who experienced IAD healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed Skin Loss | Up to three days from initiation of treatment | Examination 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) |
Countries
Singapore
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 23 |
| 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 | 37 |
| 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 | 24 |
| Total | 84 |
Baseline characteristics
| Characteristic | Soap and Water / Incontinence Wipes and Conveen Critic Barrier | Total | 3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant | Conveen EasiCleanse and Conveen Critic Barrier |
|---|---|---|---|---|
| Age, Continuous | 80.7 years STANDARD_DEVIATION 8.03 | 79.51 years STANDARD_DEVIATION 9.45 | 77.2 years STANDARD_DEVIATION 10.6 | 80.2 years STANDARD_DEVIATION 9.56 |
| Body Mass Index | 20.4 kg/m^2 STANDARD_DEVIATION 3.42 | 20.6 kg/m^2 STANDARD_DEVIATION 4.18 | 20.3 kg/m^2 STANDARD_DEVIATION 3.81 | 21.0 kg/m^2 STANDARD_DEVIATION 5.19 |
| Faecal frequency | 3.43 episodes/day STANDARD_DEVIATION 2.31 | 3.43 episodes/day STANDARD_DEVIATION 2.01 | 3.25 episodes/day STANDARD_DEVIATION 1.65 | 3.52 episodes/day STANDARD_DEVIATION 2.01 |
| Presence of indwelling urinary catheter | 3 Participants | 22 Participants | 7 Participants | 12 Participants |
| Race/Ethnicity, Customized Chinese | 22 Participants | 79 Participants | 22 Participants | 35 Participants |
| Race/Ethnicity, Customized Indian | 2 Participants | 3 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Malay | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 12 Participants | 46 Participants | 14 Participants | 20 Participants |
| Sex: Female, Male Male | 12 Participants | 38 Participants | 9 Participants | 17 Participants |
| Stool consistency Missing | 3 Participants | 16 Participants | 7 Participants | 6 Participants |
| Stool consistency Type 4 (Best Outcome) | 3 Participants | 5 Participants | 0 Participants | 2 Participants |
| Stool consistency Type 5 (Second-best) | 4 Participants | 16 Participants | 4 Participants | 8 Participants |
| Stool consistency Type 6 (Third-best outcome) | 8 Participants | 26 Participants | 6 Participants | 12 Participants |
| Stool consistency Type 7 (Worst outcome) | 6 Participants | 21 Participants | 6 Participants | 9 Participants |
| Type of incontinence Dual incontinence | 21 participants | 61 participants | 16 participants | 24 participants |
| Type of incontinence Faecal incontinence | 24 participants | 83 participants | 22 participants | 37 participants |
| Type of incontinence Urinary incontinence | 21 participants | 62 participants | 17 participants | 24 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Who Experienced IAD Healing
Total number of participants who experienced IAD healing
Time frame: Up to seven days from initiation of treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant | Number of Participants Who Experienced IAD Healing | Healed | 8 Participants |
| 3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant | Number of Participants Who Experienced IAD Healing | Censored | 15 Participants |
| Conveen EasiCleanse and Conveen Critic Barrier | Number of Participants Who Experienced IAD Healing | Healed | 12 Participants |
| Conveen EasiCleanse and Conveen Critic Barrier | Number of Participants Who Experienced IAD Healing | Censored | 25 Participants |
| Soap and Water / Incontinence Wipes and Conveen Critic Barrier | Number of Participants Who Experienced IAD Healing | Healed | 5 Participants |
| Soap and Water / Incontinence Wipes and Conveen Critic Barrier | Number of Participants Who Experienced IAD Healing | Censored | 19 Participants |
Primary
Proportion of Participants With IAD Healing
Percentage of participants who experienced IAD healing
Time frame: Up to seven days from initiation of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant | Proportion of Participants With IAD Healing | 35 percentage of participants |
| Conveen EasiCleanse and Conveen Critic Barrier | Proportion of Participants With IAD Healing | 32 percentage of participants |
| Soap and Water / Incontinence Wipes and Conveen Critic Barrier | Proportion of Participants With IAD Healing | 21 percentage of participants |
Secondary
Number of Participants Who Developed Skin Loss
Examination 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)
Time frame: Up to three days from initiation of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant | Number of Participants Who Developed Skin Loss | 0 Participants |
| Conveen EasiCleanse and Conveen Critic Barrier | Number of Participants Who Developed Skin Loss | 5 Participants |
| Soap and Water / Incontinence Wipes and Conveen Critic Barrier | Number of Participants Who Developed Skin Loss | 3 Participants |