Incontinence-associated DermatitisNCT04625426
Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis
A study testing 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant, Conveen EasiCleanse and Conveen Critic Barrier and Standard cleansing and Conveen Critic Barrier in people with Incontinence-associated Dermatitis, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Incontinence-associated Dermatitis
- What is being tested?
- 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant, Conveen EasiCleanse and Conveen Critic Barrier and Standard cleansing and Conveen Critic Barrier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Apr 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21 years and above at point of recruitment
- Diagnosed with IAD
- At regular risk of exposure to urine and faeces over their hospitalization
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Efficacy of Two Advanced Skin Treatment Regimens in Treating Incontinence-associated Dermatitis: Cluster Randomization Study
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
Read the 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.
- Conditions
- Incontinence-associated Dermatitis
- Being tested
- 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant, Conveen EasiCleanse and Conveen Critic Barrier, Standard cleansing and Conveen Critic Barrier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin ProtectantDevice
Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant
Conveen EasiCleanse and Conveen Critic BarrierDevice
Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
Standard cleansing and Conveen Critic BarrierDevice
Hospital's standard care for IAD management
| Study group | Role | What they receive |
|---|---|---|
| 3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant | Experimental | 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. Receives: Device: 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant |
| Conveen EasiCleanse and Conveen Critic Barrier | Experimental | 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. Receives: Device: Conveen EasiCleanse and Conveen Critic Barrier |
| Soap and water / Incontinence wipes and Conveen Critic Barrier | Active comparator | 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. Receives: Device: Standard cleansing and Conveen Critic Barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced IAD Healing
Total number of participants who experienced IAD healing
Measured: Up to seven days from initiation of treatment
Proportion of Participants With IAD Healing
Percentage of participants who experienced IAD healing
Measured: Up to seven days from initiation of treatment
Secondary outcomes (1)
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)
Measured: Up to three days from initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start29 Apr 2019
- Primary completion20 Jan 2020
- Study completion30 Sep 2020
Why it stopped: Early termination due to COVID-19 pandemic led to inability to reach planned sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Incontinence-associated DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ee Yuee Chan, Study director, Tan Tock Seng HospitalCheng Cheng Goh, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625426
- Sponsor's protocol ID
- SIG18037
- Status last verified
- May 2021
- First submitted
- 6 Oct 2020
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD to other researchers.
Publications
Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.
PubMed 27841440Van Tiggelen H, LeBlanc K, Campbell K, Woo K, Baranoski S, Chang YY, Dunk AM, Gloeckner M, Hevia H, Holloway S, Idensohn P, Karadag A, Koren E, Kottner J, Langemo D, Ousey K, Pokorna A, Romanelli M, Santos VLCG, Smet S, Tariq G, Van den Bussche K, Van Hecke A, Verhaeghe S, Vuagnat H, Williams A, Beeckman D. Standardizing the classification of skin tears: validity and reliability testing of the International Skin Tear Advisory Panel Classification System in 44 countries. Br J Dermatol. 2020 Jul;183(1):146-154. doi: 10.1111/bjd.18604. Epub 2019 Nov 28.
PubMed 31605618Beele H, Smet S, Van Damme N, Beeckman D. Incontinence-Associated Dermatitis: Pathogenesis, Contributing Factors, Prevention and Management Options. Drugs Aging. 2018 Jan;35(1):1-10. doi: 10.1007/s40266-017-0507-1.
PubMed 29243033
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy of Two Advanced Skin Treatment Regimens in Treating Incontinence-associated Dermatitis: Cluster Randomization Study
- ClinicalTrials.gov ID
- NCT04625426
- Acronym / sponsor ID
- SIG18037
- Conditions
- Incontinence-associated Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to COVID-19 pandemic led to inability to reach planned sample size
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Posted 5 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Cluster randomised trial
| Arm | Type | Receives |
|---|---|---|
| 3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant | Experimental | Device: 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin ProtectantSkin 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. |
| Conveen EasiCleanse and Conveen Critic Barrier | Experimental | Device: Conveen EasiCleanse and Conveen Critic BarrierSkin 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. |
| Soap and water / Incontinence wipes and Conveen Critic Barrier | Active comparator | Device: Standard cleansing and Conveen Critic BarrierSkin 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 21 years and above at point of recruitment
- Diagnosed with IAD
- At regular risk of exposure to urine and faeces over their hospitalization
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin ProtectantHypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant | Device | 3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant |
| Conveen EasiCleanse and Conveen Critic BarrierHypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream | Device | Conveen EasiCleanse and Conveen Critic Barrier |
| Standard cleansing and Conveen Critic BarrierHospital's standard care for IAD management | Device | Soap and water / Incontinence wipes and Conveen Critic Barrier |
Primary outcome
Number of Participants Who Experienced IAD Healing
Time frame: Up to seven days from initiation of treatment
Total number of participants who experienced IAD healing
Proportion of Participants With IAD Healing
Time frame: Up to seven days from initiation of treatment
Percentage of participants who experienced IAD healing
1 secondary outcome
Number of Participants Who Developed Skin Loss
Time frame: Up to three days from initiation of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27841440Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.
- Background: PubMed 31605618Van Tiggelen H, LeBlanc K, Campbell K, Woo K, Baranoski S, Chang YY, Dunk AM, Gloeckner M, Hevia H, Holloway S, Idensohn P, Karadag A, Koren E, Kottner J, Langemo D, Ousey K, Pokorna A, Romanelli M, Santos VLCG, Smet S, Tariq G, Van den Bussche K, Van Hecke A, Verhaeghe S, Vuagnat H, Williams A, Beeckman D. Standardizing the classification of skin tears: validity and reliability testing of the International Skin Tear Advisory Panel Classification System in 44 countries. Br J Dermatol. 2020 Jul;183(1):146-154. doi: 10.1111/bjd.18604. Epub 2019 Nov 28.
- Background: PubMed 29243033Beele H, Smet S, Van Damme N, Beeckman D. Incontinence-Associated Dermatitis: Pathogenesis, Contributing Factors, Prevention and Management Options. Drugs Aging. 2018 Jan;35(1):1-10. doi: 10.1007/s40266-017-0507-1.
- Individual participant dataSharing planned: No. No plans to share IPD to other researchers.
Related trials for Incontinence-associated Dermatitis
Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Not yet recruiting
Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage
Moisture Associated Skin Damage, Incontinence Associated Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
Moisture Associated Skin Damage, Fecal Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ee Yuee Chan study director
Tan Tock Seng Hospital
Cheng Cheng Goh principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant, Conveen EasiCleanse and Conveen Critic Barrier and Standard cleansing and Conveen Critic Barrier in people with Incontinence-associated Dermatitis, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced IAD Healing (time frame: Up to seven days from initiation of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04625426, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.