Irritant DermatitisISR-CASP-MASDNCT06178289
Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Moisture-associated Skin Damage in Hospitals
A study testing 3M Cavilon Advanced Skin Protectant and Standard hospital wound treatment protocol in people with Irritant Dermatitis and Stoma Site Dermatitis, run by University Ghent at 3 sites in Belgium.
Trial summary
Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture (MASD) compared to usual wound care treatment. Methodology: RESEARCH DESIGN: A randomized controlled multicentre clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritant Dermatitis, Stoma Site Dermatitis, Wound of Skin
- What is being tested?
- 3M Cavilon Advanced Skin Protectant and Standard hospital wound treatment protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesBelgium
- Study dates
- 27 Jan 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The patient or their legally authorized representative signed informed consent.
- The patient is expected to be in the study for the full duration of the trial.
- The patient has partial thickness wounds caused by moisture (MASD) i.e.,
- The patient has IAD category 2A or
- Peri-wound MASD or
- Peri-stomal MASD.
Who cannot join
- Patients with a known hypersensitivity or allergy to acrylate or cyanoacrylate.
- The patient requires topical treatment due to a fungal, bacterial or viral infection in the study area.
- Intertriginous dermatitis (most often a fungal infection is present).
- Peri-fistula MASD (would usually require hospitalization).
- The patient has any other local dermatological disease or skin condition interfering with this study.
- Patients participating in another study with a known or implied effect on skin barrier function.
- Patients who are receiving end-of-life care.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites
Ziekenhuis Aan de Stroom (ZAS)
Antwerp, 2030
Ghent University Hospital
Ghent
AZ Oudenaarde
Oudenaarde
About this study
Official title: The Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Partial-thickness Wounds Caused by Moisture-associated Skin Damage Compared to Usual Wound Care Treatment in Hospitals: a Multi-centre RCT
Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture (MASD) compared to usual wound care treatment.
Methodology:
Read more
RESEARCH DESIGN: A randomized controlled multicentre clinical trial.
DATA COLLECTION:
Randomization/Blinding and Participant Numbering: The patients will be allocated 1:1 by block randomization, using the REDCap Randomization Module, to either Cavilon™ Advanced Skin Protectant or local hospital partial-thickness wound (MASD) treatment protocol, yielding one study group. Due to the obvious differences between the comparative hospital wound care treatment products and the study device, the study nurses cannot be blinded. A blinded assessor will centrally assess the time to healing and other healing outcomes based on the photographs of the study area.
Study area: Defined as all partial-thickness, skin damaged areas on the body - due to exposure to (a) incontinence body fluids, (b) wound exudate, (c) stomal- or fistula effluent or digestive secretions.
Study duration: 21 days or until complete healing of the moisture associated skin damage (complete epithelialization).
Skin (MASD) assessment: Daily skin assessment of the study area is to be conducted by the study nurses. Relevant wound and patient information will be recorded (incontinence status, presence of a urinary catheter or faecal management system, number of absorbent pad or diaper changes, number of cleansing procedures, type of stoma, number of applications regarding Cavilon Advanced Skin Protectant or usual hospital wound treatment protocol). Digital planimetry software (PictZar® version 7.6.1 ss) will be the main mode of assessing wound healing. Therefore, daily photographs will be taken with each daily skin assessment after removal of all visual product to ensure blinded skin assessment by the central reviewer.
Pain assessment: The Numeric Rating Scale (NRS) or Crital care Pain Observation Tool (CPOT) will be used to assess pain daily. Treatment-related pain (pain experienced during treatment (cleansing and product application)) and wound related pain (pain perception specifically caused by the MASD lesion) will be assessed.
Nursing time assessment: Time per cleansing and time per treatment application.
Read the detailed description
Problem statement:
Partial-thickness wounds (erosion/denudation of the epithelial and dermal layers of the skin) can occur due to prolonged exposure of moisture and irritants. Various sources of moisture can cause these superficial wounds called moisture-associated skin damage (MASD) which include wound exudate, bodily fluids from incontinence and effluent from stomas and fistulas. MASD can present as inflammation with or without erosion and even secondary infection. Partial-thickness denudation can be extremely painful and detrimental to the patient. Traditionally a wide array of treatment options is used in clinical practice, yet there is a lack of robust studies comparing newer technologies with current practices. 3M™ Cavilon™ Advanced Skin Protectant, launched in 2017, is a newer cyanoacrylate-based medical device indicated for treatment of partial-thickness skin loss and is the only cyanoacrylate-based barrier product available on the Belgian market.
Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture (MASD) compared to usual wound care treatment.
Methodology:
RESEARCH DESIGN: A randomized controlled multicentre clinical trial.
DATA COLLECTION:
Procedure: Demographics and Participant Characteristics: Patient demographics will be recorded in REDCap eCRFs on study schedule Day 01: gender, age, height, weight, co-morbidities.
Randomization/Blinding and Participant Numbering: The patients will be allocated 1:1 by block randomization, using the REDCap Randomization Module, to either Cavilon™ Advanced Skin Protectant or local hospital partial-thickness wound (MASD) treatment protocol, yielding one study group. Due to the obvious differences between the comparative hospital wound care treatment products and the study device, the study nurses cannot be blinded. A blinded assessor will assess the time to healing and other healing outcomes centrally based on the photographs of the study area.
Study area: Defined as all partial-thickness, skin damaged areas on the body - due to exposure to (a) incontinence body fluids, (b) wound exudate, (c) stomal- or fistula effluent or digestive secretions.
Study duration: 21 days or until complete healing of the moisture associated skin damage (complete epithelialization).
Hypothesis: 3M™ Cavilon™ Advanced Skin Protectant is more effective in the treatment of partial-thickness wounds caused by moisture (moisture-associated skin damage) compared to usual wound care treatment in hospitals.
Skin (MASD) assessment: Daily skin assessment of the study area is to be conducted by the study nurses. Relevant wound and patient information will be recorded. This information includes incontinence status, presence of a urinary catheter or faecal management system, number of absorbent pad or diaper changes, number of cleansing procedures, type of stoma, number of applications regarding Cavilon Advanced Skin Protectant or usual hospital wound treatment protocol. Daily photographs will be taken with each daily skin assessment after removal of all visual product to ensure blinded skin assessment by the central reviewer. Digital planimetry software (PictZar® version 7.6.1 ss) will be the main mode of assessing wound healing. The central reader will perform a blinded skin assessment based on the provided photographic documentation of the study area.
Pain assessment: The Numeric Rating Scale (NRS) or Crital care Pain Observation Tool (CPOT) will be used to assess pain daily. Treatment-related pain (pain experienced during treatment (cleansing and product application)) and wound related pain (pain perception specifically caused by the MASD lesion) will be assessed.
Nursing time assessment: Time per cleansing and time per treatment application will be done on days 4 and 7 using a stopwatch.
DATA ANALYSIS:
All quantitative data will be summarized with descriptive statistics.
Inferential analysis: Cox proportional hazards will be used to calculate the primary efficacy variable. Linear mixed logistic regressions and linear mixed models will be used to calculate the secondary objectives.
Exploratory analysis: Cox proportional hazards will be used to calculate the primary efficacy variable. Linear mixed logistic regressions and linear mixed models will be used to calculate the secondary objectives.
Health economic evaluation: A cost-effectiveness analysis will be performed with an institutional perspective in a Belgian context. Total cost will be calculated by the sum of the total product cost and the total cost of nursing time. Costs will be averaged within each group and compared using a two-signed t-test at an alpha level of 5%. A cost-effectiveness analysis will be performed by calculating the ICER. The ICER will be expressed in euros per wound healed per patient.
- Conditions
- Irritant Dermatitis, Stoma Site Dermatitis, Wound of Skin
- Being tested
- 3M Cavilon Advanced Skin Protectant, Standard hospital wound treatment protocol
- Medical subject headings
- Dermatitis, Irritant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M Cavilon Advanced Skin ProtectantDevice
Also called cyanoacrylate based film
3M Cavilon Advanced Skin Protectant is applied to the study area of partial-thickness wounds (IAD category 2A, peri-wound MASD, peri-stomal MASD). Application of the study device should be according to the manufacturer's IFU. Comprehensive training for nurses will be provided to the study nurses.
Standard hospital wound treatment protocolDevice
Comparator: Standard hospital wound treatment protocol
| Study group | Role | What they receive |
|---|---|---|
| 3M Cavilon Advanced Skin Protectant | Experimental | 3M Cavilon Advanced Skin Protectant (2,7ml) is a cyanoacrylate based film and will be administered every third day for a study period of 21 days. Receives: Device: 3M Cavilon Advanced Skin Protectant |
| Standard hospital wound treatment protocol | Active comparator | Usual wound treatment care provided in the hospital will be administered. Receives: Device: Standard hospital wound treatment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete epithelialization
Number of days from commencement of application of study device or comparator to the study area to complete resolution of partial-thickness wound
Measured: Day 01 - Day 21
Secondary outcomes (5)
Proportion of participants with complete epithelialization
The proportion of patients with partial-thickness wounds completely healed at days 7, 14 and 21
Measured: Day 07, Day 14, Day 21
Mean change in treatment related pain
The mean change in patients' perception of treatment-related pain using the Wong-Baker FACES Pain Rating Scale from baseline to day 21.
Measured: Day 01 - Day 21
Mean change in wound pain
The mean change in patients' perception of wound pain using the Wong-Baker FACES Pain Rating Scale before treatment, 30 minutes after the first treatment, 24 hours after the first treatment, on day 4, and on day 7.
Measured: Day 01, Day 02, Day 04, Day 07
Change in maceration surface area
The percent of change in maceration (area) at days 7, 14, and 21.
Measured: Day 07, Day 14, Day 21
Total treatment cost
To investigate the total cost of treating partial-thickness wounds including number of applications, product costs and nursing time assessments to measure time per cleansing and time per treatment application on day 4 and 7 (by researcher).
Measured: Day 04, Day 07
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start27 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Irritant DermatitisStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Dimitri Beeckman, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178289
- Sponsor's protocol ID
- ONZ-2022-0527
- Acronym
- ISR-CASP-MASD
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Woo KY, Beeckman D, Chakravarthy D. Management of Moisture-Associated Skin Damage: A Scoping Review. Adv Skin Wound Care. 2017 Nov;30(11):494-501. doi: 10.1097/01.ASW.0000525627.54569.da.
PubMed 29049257Gray M, Black JM, Baharestani MM, Bliss DZ, Colwell JC, Goldberg M, Kennedy-Evans KL, Logan S, Ratliff CR. Moisture-associated skin damage: overview and pathophysiology. J Wound Ostomy Continence Nurs. 2011 May-Jun;38(3):233-41. doi: 10.1097/WON.0b013e318215f798.
PubMed 21490547Beeckman D, Van den Bussche K, Alves P, Arnold Long MC, Beele H, Ciprandi G, Coyer F, de Groot T, De Meyer D, Deschepper E, Dunk AM, Fourie A, Garcia-Molina P, Gray M, Iblasi A, Jelnes R, Johansen E, Karadag A, Leblanc K, Kis Dadara Z, Meaume S, Pokorna A, Romanelli M, Ruppert S, Schoonhoven L, Smet S, Smith C, Steininger A, Stockmayr M, Van Damme N, Voegeli D, Van Hecke A, Verhaeghe S, Woo K, Kottner J. Towards an international language for incontinence-associated dermatitis (IAD): design and evaluation of psychometric properties of the Ghent Global IAD Categorization Tool (GLOBIAD) in 30 countries. Br J Dermatol. 2018 Jun;178(6):1331-1340. doi: 10.1111/bjd.16327. Epub 2018 Apr 19.
PubMed 29315488
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Partial-thickness Wounds Caused by Moisture-associated Skin Damage Compared to Usual Wound Care Treatment in Hospitals: a Multi-centre RCT
- ClinicalTrials.gov ID
- NCT06178289
- Acronym / sponsor ID
- ISR-CASP-MASD / ONZ-2022-0527
- Conditions
- Irritant Dermatitis, Stoma Site Dermatitis, Wound of Skin
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture (MASD) compared to usual wound care treatment.
Methodology:
RESEARCH DESIGN: A randomized controlled multicentre clinical trial.
DATA COLLECTION:
Randomization/Blinding and Participant Numbering: The patients will be allocated 1:1 by block randomization, using the REDCap Randomization Module, to either Cavilon™ Advanced Skin Protectant or local hospital partial-thickness wound (MASD) treatment protocol, yielding one study group. Due to the obvious differences between the comparative hospital wound care treatment products and the study device, the study nurses cannot be blinded. A blinded assessor will centrally assess the time to healing and other healing outcomes based on the photographs of the study area.
Study area: Defined as all partial-thickness, skin damaged areas on the body - due to exposure to (a) incontinence body fluids, (b) wound exudate, (c) stomal- or fistula effluent or digestive secretions.
Study duration: 21 days or until complete healing of the moisture associated skin damage (complete epithelialization).
Skin (MASD) assessment: Daily skin assessment of the study area is to be conducted by the study nurses. Relevant wound and patient information will be recorded (incontinence status, presence of a urinary catheter or faecal management system, number of absorbent pad or diaper changes, number of cleansing procedures, type of stoma, number of applications regarding Cavilon Advanced Skin Protectant or usual hospital wound treatment protocol). Digital planimetry software (PictZar® version 7.6.1 ss) will be the main mode of assessing wound healing. Therefore, daily photographs will be taken with each daily skin assessment after removal of all visual product to ensure blinded skin assessment by the central reviewer.
Pain assessment: The Numeric Rating Scale (NRS) or Crital care Pain Observation Tool (CPOT) will be used to assess pain daily. Treatment-related pain (pain experienced during treatment (cleansing and product application)) and wound related pain (pain perception specifically caused by the MASD lesion) will be assessed.
Nursing time assessment: Time per cleansing and time per treatment application.
Detailed description
Problem statement:
Partial-thickness wounds (erosion/denudation of the epithelial and dermal layers of the skin) can occur due to prolonged exposure of moisture and irritants. Various sources of moisture can cause these superficial wounds called moisture-associated skin damage (MASD) which include wound exudate, bodily fluids from incontinence and effluent from stomas and fistulas. MASD can present as inflammation with or without erosion and even secondary infection. Partial-thickness denudation can be extremely painful and detrimental to the patient. Traditionally a wide array of treatment options is used in clinical practice, yet there is a lack of robust studies comparing newer technologies with current practices. 3M™ Cavilon™ Advanced Skin Protectant, launched in 2017, is a newer cyanoacrylate-based medical device indicated for treatment of partial-thickness skin loss and is the only cyanoacrylate-based barrier product available on the Belgian market.
Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture (MASD) compared to usual wound care treatment.
Methodology:
RESEARCH DESIGN: A randomized controlled multicentre clinical trial.
DATA COLLECTION:
Procedure: Demographics and Participant Characteristics: Patient demographics will be recorded in REDCap eCRFs on study schedule Day 01: gender, age, height, weight, co-morbidities.
Randomization/Blinding and Participant Numbering: The patients will be allocated 1:1 by block randomization, using the REDCap Randomization Module, to either Cavilon™ Advanced Skin Protectant or local hospital partial-thickness wound (MASD) treatment protocol, yielding one study group. Due to the obvious differences between the comparative hospital wound care treatment products and the study device, the study nurses cannot be blinded. A blinded assessor will assess the time to healing and other healing outcomes centrally based on the photographs of the study area.
Study area: Defined as all partial-thickness, skin damaged areas on the body - due to exposure to (a) incontinence body fluids, (b) wound exudate, (c) stomal- or fistula effluent or digestive secretions.
Study duration: 21 days or until complete healing of the moisture associated skin damage (complete epithelialization).
Hypothesis: 3M™ Cavilon™ Advanced Skin Protectant is more effective in the treatment of partial-thickness wounds caused by moisture (moisture-associated skin damage) compared to usual wound care treatment in hospitals.
Skin (MASD) assessment: Daily skin assessment of the study area is to be conducted by the study nurses. Relevant wound and patient information will be recorded. This information includes incontinence status, presence of a urinary catheter or faecal management system, number of absorbent pad or diaper changes, number of cleansing procedures, type of stoma, number of applications regarding Cavilon Advanced Skin Protectant or usual hospital wound treatment protocol. Daily photographs will be taken with each daily skin assessment after removal of all visual product to ensure blinded skin assessment by the central reviewer. Digital planimetry software (PictZar® version 7.6.1 ss) will be the main mode of assessing wound healing. The central reader will perform a blinded skin assessment based on the provided photographic documentation of the study area.
Pain assessment: The Numeric Rating Scale (NRS) or Crital care Pain Observation Tool (CPOT) will be used to assess pain daily. Treatment-related pain (pain experienced during treatment (cleansing and product application)) and wound related pain (pain perception specifically caused by the MASD lesion) will be assessed.
Nursing time assessment: Time per cleansing and time per treatment application will be done on days 4 and 7 using a stopwatch.
DATA ANALYSIS:
All quantitative data will be summarized with descriptive statistics.
Inferential analysis: Cox proportional hazards will be used to calculate the primary efficacy variable. Linear mixed logistic regressions and linear mixed models will be used to calculate the secondary objectives.
Exploratory analysis: Cox proportional hazards will be used to calculate the primary efficacy variable. Linear mixed logistic regressions and linear mixed models will be used to calculate the secondary objectives.
Health economic evaluation: A cost-effectiveness analysis will be performed with an institutional perspective in a Belgian context. Total cost will be calculated by the sum of the total product cost and the total cost of nursing time. Costs will be averaged within each group and compared using a two-signed t-test at an alpha level of 5%. A cost-effectiveness analysis will be performed by calculating the ICER. The ICER will be expressed in euros per wound healed per patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3M Cavilon Advanced Skin Protectant | Experimental | Device: 3M Cavilon Advanced Skin Protectant3M Cavilon Advanced Skin Protectant (2,7ml) is a cyanoacrylate based film and will be administered every third day for a study period of 21 days. |
| Standard hospital wound treatment protocol | Active comparator | Device: Standard hospital wound treatment protocolUsual wound treatment care provided in the hospital will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient or their legally authorized representative signed informed consent.
- The patient is expected to be in the study for the full duration of the trial.
- The patient has partial thickness wounds caused by moisture (MASD) i.e.,
Key exclusion criteria (7 listed)
- Patients with a known hypersensitivity or allergy to acrylate or cyanoacrylate.
- The patient requires topical treatment due to a fungal, bacterial or viral infection in the study area.
- Intertriginous dermatitis (most often a fungal infection is present).
- Peri-fistula MASD (would usually require hospitalization).
- The patient has any other local dermatological disease or skin condition interfering with this study.
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 Advanced Skin ProtectantAlso: cyanoacrylate based film3M Cavilon Advanced Skin Protectant is applied to the study area of partial-thickness wounds (IAD category 2A, peri-wound MASD, peri-stomal MASD). Application of the study device should be according to the manufacturer's IFU. Comprehensive training for nurses will be provided to the study nurses. | Device | 3M Cavilon Advanced Skin Protectant |
| Standard hospital wound treatment protocolComparator: Standard hospital wound treatment protocol | Device | Standard hospital wound treatment protocol |
Primary outcome
Time to complete epithelialization
Time frame: Day 01 - Day 21
Number of days from commencement of application of study device or comparator to the study area to complete resolution of partial-thickness wound
5 secondary outcomes
Proportion of participants with complete epithelialization
Time frame: Day 07, Day 14, Day 21
Mean change in treatment related pain
Time frame: Day 01 - Day 21
Mean change in wound pain
Time frame: Day 01, Day 02, Day 04, Day 07
Change in maceration surface area
Time frame: Day 07, Day 14, Day 21
Total treatment cost
Time frame: Day 04, Day 07
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 29049257Woo KY, Beeckman D, Chakravarthy D. Management of Moisture-Associated Skin Damage: A Scoping Review. Adv Skin Wound Care. 2017 Nov;30(11):494-501. doi: 10.1097/01.ASW.0000525627.54569.da.
- Background: PubMed 21490547Gray M, Black JM, Baharestani MM, Bliss DZ, Colwell JC, Goldberg M, Kennedy-Evans KL, Logan S, Ratliff CR. Moisture-associated skin damage: overview and pathophysiology. J Wound Ostomy Continence Nurs. 2011 May-Jun;38(3):233-41. doi: 10.1097/WON.0b013e318215f798.
- Background: PubMed 29315488Beeckman D, Van den Bussche K, Alves P, Arnold Long MC, Beele H, Ciprandi G, Coyer F, de Groot T, De Meyer D, Deschepper E, Dunk AM, Fourie A, Garcia-Molina P, Gray M, Iblasi A, Jelnes R, Johansen E, Karadag A, Leblanc K, Kis Dadara Z, Meaume S, Pokorna A, Romanelli M, Ruppert S, Schoonhoven L, Smet S, Smith C, Steininger A, Stockmayr M, Van Damme N, Voegeli D, Van Hecke A, Verhaeghe S, Woo K, Kottner J. Towards an international language for incontinence-associated dermatitis (IAD): design and evaluation of psychometric properties of the Ghent Global IAD Categorization Tool (GLOBIAD) in 30 countries. Br J Dermatol. 2018 Jun;178(6):1331-1340. doi: 10.1111/bjd.16327. Epub 2018 Apr 19.
- Individual participant dataSharing planned: No
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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.
Dimitri Beeckman, PhD principal investigator
University Ghent
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M Cavilon Advanced Skin Protectant and Standard hospital wound treatment protocol in people with Irritant Dermatitis and Stoma Site Dermatitis, run by University Ghent at 3 sites in Belgium.
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 7 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: enrolling by invitation, as of the sponsor's last update on 17 Dec 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to complete epithelialization (time frame: Day 01 - Day 21). 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 NCT06178289, 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 17 Dec 2025.