Incontinence-associated DermatitisNCT03298113
Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis
A study testing Cavilon Advanced Skin Protectant in people with Incontinence-associated Dermatitis, run by Solventum US LLC at 3 sites in 3 countries.
Trial summary
The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: Incontinence-associated Dermatitis) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incontinence-associated Dermatitis
- What is being tested?
- Cavilon Advanced Skin Protectant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 17 Nov 2017to 10 Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is the patient 18 years or older?
- Has the patient or their legally authorized representative signed the Informed Consent Form?
- Does the patient have IAD category 1A (IAD 1A: persistent redness without clinical signs of infection) or IAD category 2A (IAD 2A: skin loss without clinical signs of infection) in the study area (study area: the sacral region going down to the upper thighs, bordered approximately 5 cm below the gluteal fold?
- Is the patient incontinent and does stool and/or urine come into direct contact with the skin?
- Is the patient able to be turned/positioned with regard to skin assessment and photo documentation?
- Is there a reasonable expectation that the patient will remain in the hospital setting for at least 7 days?
Who cannot join
- Is the patient pregnant or breast feeding?
- Does the patient have a known hypersensitivity or allergy to acrylate or cyanoacrylate?
- Does the patient have a stage II, III, IV or unstageable pressure ulcer or other suspected deep tissue injury in the study area?
- Does the patient require topical treatment due to a fungal, bacterial or viral infection in the study area?
- Does the patient require treatment with topical medication or product other than IAD treatment in the study area?
- Does the patient have any other local dermatological disease or skin condition interfering with this study?
- Does the patient have any medical condition (e.g. end of life, planned elective surgery) that in the opinion of the investigator should exclude him/her from participating in the study?
- Does the patient participate in another study with a known or implied effect on skin barrier function?
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
University Hospital Southampton
Southampton, SO16 6YD
About this study
Official title: Effects of an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis Compared to Hospital Standard Care Practice: an Exploratory Randomized Controlled Trial
The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: Incontinence-associated Dermatitis)
Read the detailed description
The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: incontinence-associated dermatitis). IAD is a skin damage caused by exposure to moisture and irritants such as urine and/or stool. The clinical appearance ranges from painful erythema to severe erosion and denudation/skin loss with or without secondary infection. The durable, long lasting skin protectant (3M study device) is formulated to attach to moist or wet skin surfaces (i.e., superficial, partial thickness skin loss) to provide better protection against moisture and irritants under challenging conditions.
- Conditions
- Incontinence-associated Dermatitis
- Being tested
- Cavilon Advanced Skin Protectant, IAD Hospital Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cavilon Advanced Skin ProtectantDevice
Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.
IAD Hospital Standard CareDevice
Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.
| Study group | Role | What they receive |
|---|---|---|
| Cavilon Advanced Skin Protectant | Experimental | Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. Receives: Device: Cavilon Advanced Skin Protectant |
| IAD Hospital Standard Care | Other | Marketed products are applied according to the IAD hospital standard care routine. Receives: Device: IAD Hospital Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of IAD
Number and percentage of patients completely healed (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)
Note: Due to the exploratory design no formal a priori hypothesis was defined for this study. The outcome measure type for all endpoints is "other pre-specified". The effects were analyzed using descriptive statistics. No confirmatory statements can be made about the effects and no comparative statements are possible. The sponsor decided to early terminate the study after 20 evaluable patients for the intention-to-treat analysis. Reason for the early termination was the slow enrollment rate of patients and overall short length of stay in hospital.
Measured: up to 21 days depending on length of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start17 Nov 2017
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Why it stopped: slow enrollment
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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Matthew M. Cooper, MD, Study director, 3M
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298113
- Sponsor's protocol ID
- CLIN-PROT-EU-05-293312
- Status last verified
- Nov 2024
- First submitted
- 21 Aug 2017
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis Compared to Hospital Standard Care Practice: an Exploratory Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03298113
- Acronym / sponsor ID
- CLIN-PROT-EU-05-293312
- Conditions
- Incontinence-associated Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Posted 24 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: Incontinence-associated Dermatitis)
Detailed description
The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: incontinence-associated dermatitis). IAD is a skin damage caused by exposure to moisture and irritants such as urine and/or stool. The clinical appearance ranges from painful erythema to severe erosion and denudation/skin loss with or without secondary infection. The durable, long lasting skin protectant (3M study device) is formulated to attach to moist or wet skin surfaces (i.e., superficial, partial thickness skin loss) to provide better protection against moisture and irritants under challenging conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cavilon Advanced Skin Protectant | Experimental | Device: Cavilon Advanced Skin ProtectantProduct applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. |
| IAD Hospital Standard Care | Other | Device: IAD Hospital Standard CareMarketed products are applied according to the IAD hospital standard care routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Is the patient 18 years or older?
- Has the patient or their legally authorized representative signed the Informed Consent Form?
- Does the patient have IAD category 1A (IAD 1A: persistent redness without clinical signs of infection) or IAD category 2A (IAD 2A: skin loss without clinical signs of infection) in the study area (study area: the sacral region going down to the upper thighs, bordered approximately 5 cm below the gluteal fold?
- Is the patient incontinent and does stool and/or urine come into direct contact with the skin?
- Is the patient able to be turned/positioned with regard to skin assessment and photo documentation?
Key exclusion criteria (8 listed)
- Is the patient pregnant or breast feeding?
- Does the patient have a known hypersensitivity or allergy to acrylate or cyanoacrylate?
- Does the patient have a stage II, III, IV or unstageable pressure ulcer or other suspected deep tissue injury in the study area?
- Does the patient require topical treatment due to a fungal, bacterial or viral infection in the study area?
- Does the patient require treatment with topical medication or product other than IAD treatment in the study area?
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 |
|---|---|---|
| Cavilon Advanced Skin ProtectantApplicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. | Device | Cavilon Advanced Skin Protectant |
| IAD Hospital Standard CareDevices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use. | Device | IAD Hospital Standard Care |
Primary outcome
Healing of IAD
Time frame: up to 21 days depending on length of hospitalization
Number and percentage of patients completely healed (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool) Note: Due to the exploratory design no formal a priori hypothesis was defined for this study. The outcome measure type for all endpoints is "other pre-specified". The effects were analyzed using descriptive statistics. No confirmatory statements can be made about the effects and no comparative statements are possible. The sponsor decided to early terminate the study after 20 evaluable patients for the intention-to-treat analysis. Reason for the early termination was the slow enrollment rate of patients and overall short length of stay in hospital.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
Not yet recruiting
Prevention of Incontinence-associated Dermatitis and Maintenance of Local Skin Microclimate：A Multicenter Study
Incontinence-associated Dermatitis
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.
Matthew M. Cooper, MD study director
3M
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cavilon Advanced Skin Protectant in people with Incontinence-associated Dermatitis, run by Solventum US LLC at 3 sites in 3 countries.
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 6 inclusion and 8 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 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Germany, United Kingdom. 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 24 Sep 2019). 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?
Healing of IAD (time frame: up to 21 days depending on length of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2024.