Incontinence Associated DermatitisNCT02570139
Clinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontinence & Allow Healing
A study testing Cavilon Advanced Skin Protectant and ConvaTec Sensi-Care Protective Barrier in people with Incontinence Associated Dermatitis, run by Solventum US LLC at 10 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of the investigational product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of incontinence associated dermatitis. Read more about this study
- Who is it for?
- Ages 1 hour and older
- Conditions the study is for
- Incontinence Associated Dermatitis
- What is being tested?
- Cavilon Advanced Skin Protectant and ConvaTec Sensi-Care Protective Barrier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2015to 23 Jun 2017
- 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 1 hour and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects may be enrolled into this study if the answers to all these questions are yes.
- Is the subject a full-term newborn (36 weeks or greater gestational age) or older?
- Is the subject in a facility providing nursing care 24 hours per day?
- Does the subject have severe Category 2 Incontinence-Associated Dermatitis (IAD) -red with skin breakdown (i.e. skin erosion and denudation or denudation of skin alone)?
- Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of photographs in potential publication?
- Is the subject willing to release rights to 3M for the use of the photos?
- Is there a reasonable expectation that the subject will remain in a facility for at least 7 days following enrollment in the study?
- Has the subject, or their legally authorized representative, signed an Institutional Review Board-approved informed consent/assent document and authorized the use and disclosure of protected health information?
Who cannot join
- Subjects are excluded from participation in this study if any of the answers to these following questions is yes.
- If female, is the subject pregnant or breast feeding or has she given birth within the 3 weeks preceding the screening visit?
- Does the subject have a known allergy to acrylates or cyanoacrylates?
- Does the subject have a Stage III, IV, unstageable, suspected deep tissue injury pressure ulcer in the area where the skin is affected by incontinence?
- Does the subject have a preexisting skin disease on the areas affected by incontinence that may make skin assessments for this study difficult?
- Does the skin area affected by incontinence require treatment with a concomitant medication or product?
Show all 13Show fewer
- Does the subject have an active genital herpes infection?
- Has the subject received antifungal powders in the area affected with IAD within 24 hours prior to enrollment?
- Has the subject received cyanoacrylate based skin protectant (such as Marathon) within 72 hours prior to enrollment?
- Is the facility unwilling to discontinue use for this subject of Dimethicone-containing wipes on the area where the skin protectant product will be applied?
- Is the facility unwilling to discontinue use for this subject of Chlorhexidine Gluconate wipes on the area where the skin protectant product will be applied?
- Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
- Has the subject been enrolled in any investigational study where product was applied to proposed study sites within 30 days of the screening visit?
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Roper St. Francis
Charleston, South Carolina, 29401
Hackensack University Medical Center
Hackensack, New Jersey, 76010
Good Samaritan
Kearney, Nebraska, 68848
St. Elizabeth
Lincoln, Nebraska, 68510
North Shore University Hospital
Manhasset, New York, 11030
Children's Hospitals and Clinic
Minneapolis, Minnesota, 55404
Lennox Hill
New York, New York, 10075
Baylor Plano
Plano, Texas, 75093
Children's Hospital and Clinics
Saint Paul, Minnesota, 55102
St. John
Tulsa, Oklahoma, 74104
About this study
Official title: Multi-Center, Randomized Trial Comparing the Efficacy of 3M™ Cavilon™ Advanced Barrier Film for the Treatment of Incontinence-associated Dermatitis to a Commercially Available Moisture Barrier
The purpose of the study is to evaluate the safety and efficacy of the investigational product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of incontinence associated dermatitis.
Read the detailed description
The purpose of this study is to evaluated the product performance of a new skin protectant formulated to protect damaged and denuded skin even in the presence of exposure to the most potentially damaging body fluids, such as liquid stool and gastric fluid. The product is expected to intimately adhere to damaged and denuded skin and provide better protection from further damage than commonly used products such as moisture barrier pastes, thereby making it easier for nursing staff to cleanse the skin after incontinence episodes, thus saving time and also materials.
The denuded sites on buttocks/thighs will be scored for skin loss and degree of redness. Over the course of time, with the skin protected, it should re-epithelizes. The skin improvement will be scored and the change in baseline over time monitored.
- Conditions
- Incontinence Associated Dermatitis
- Being tested
- Cavilon Advanced Skin Protectant, ConvaTec Sensi-Care Protective Barrier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cavilon Advanced Skin ProtectantDevice
The liquid barrier film flows from the applicator and dries quickly on the skin. It is durable for 72-96 hours under conditions of incontinence.
ConvaTec Sensi-Care Protective BarrierDevice
Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
| Study group | Role | What they receive |
|---|---|---|
| Cavilon Advanced Skin Protectant | Experimental | Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week. Receives: Device: Cavilon Advanced Skin Protectant |
| ConvaTec Sensi-Care Protective Barrier | Active comparator | Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum. Receives: Device: ConvaTec Sensi-Care Protective Barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to End of Study in Incontinence Associated Dermatitis (IAD) Scores
Primary endpoint was percent decrease in Incontinence Associated Dermatitis (IAD) score from baseline to end of subject's participation. A negative value indicates increased IAD score; a positive value indicates decreased IAD score. IAD scores were calculated for 6 anatomical zones for color, presence of lesions, and skin loss using 3M's Skin Condition Assessment Tool. Skin condition assessed for 1) epidermal loss depth \& area involved; 2) skin color intact skin \& % area if not normal color. Intensity scored based on % area involved. Epidermal loss intensity rating scores ranged from 0 (none) - 4 (76-100%) partial (skin open, not weeping) or complete (skin open \& weeping). Color of intact skin rating scores ranged from 0 (skin color normal) - 4 (76-100%) skin color pink or red. Scores for each of the 6 body zones were combined to obtain a single IAD score for each subject. IAD scores ranged from 0 (best) - 720 (worst).
Measured: up to 21 days depending on length of hospitalization
Secondary outcomes (3)
Re-epithelialization to a Category 1 or Lower
Looking for healing of denuded skin to re-epithelialized skin.
Measured: Up to 21 days depending on length of hospitalization
Pain Scores During Incontinence Management
Pain scores during incontinence management were measured on a 0-10 scale, and analyzed only for subjects from the intent-to-treat dataset who could report pain. Adult pain was measured on 0-10 Wong-Baker FACES® Pain Scale Visual Analog to see if there is pain reduction (0 - no pain; 10 - worst pain). Pain in pediatric patients was measured with the 0-10 FLACC (Face, Legs, Activity, Cry, Consolability Behavioral) Tool. FLACC tool scores pain based on 5 categories, each scored on 0-2 scale and a total score calculated from the sum of the 5 categories for a total possible 0 (no pain) - 10 (worst pain) score. Data from the 2 scales were combined for analysis. Reduction in pain scores collected during product application were reported and least squares means adjusted for baseline pain score as a covariate were calculated. Negative value indicates reduction in pain score; positive value indicates increased pain score.
Measured: Up to 21 days depending on length of hospitalization
Prevention of IAD.
Number of subjects with areas of buttock and thighs that were free of IAD at baseline and remained free of damage with ongoing incontinence through 5 days of treatment.
Measured: Measured at study day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion23 Jun 2017
- Study completion23 Jun 2017
Why it stopped: Low enrollment, short stay; lacked statistically powered evaluation for efficacy.
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Pat Parks, MD, Study director, 3M
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570139
- Sponsor's protocol ID
- EM-05-012990
- Status last verified
- Sep 2024
- First submitted
- 6 Oct 2015
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized Trial Comparing the Efficacy of 3M™ Cavilon™ Advanced Barrier Film for the Treatment of Incontinence-associated Dermatitis to a Commercially Available Moisture Barrier
- ClinicalTrials.gov ID
- NCT02570139
- Acronym / sponsor ID
- EM-05-012990
- Conditions
- Incontinence Associated Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment, short stay; lacked statistically powered evaluation for efficacy.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Oct 2015
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 23 Jun 2017 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Posted 12 Oct 2018
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 study is to evaluate the safety and efficacy of the investigational product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of incontinence associated dermatitis.
Detailed description
The purpose of this study is to evaluated the product performance of a new skin protectant formulated to protect damaged and denuded skin even in the presence of exposure to the most potentially damaging body fluids, such as liquid stool and gastric fluid. The product is expected to intimately adhere to damaged and denuded skin and provide better protection from further damage than commonly used products such as moisture barrier pastes, thereby making it easier for nursing staff to cleanse the skin after incontinence episodes, thus saving time and also materials.
The denuded sites on buttocks/thighs will be scored for skin loss and degree of redness. Over the course of time, with the skin protected, it should re-epithelizes. The skin improvement will be scored and the change in baseline over time monitored.
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 applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week. |
| ConvaTec Sensi-Care Protective Barrier | Active comparator | Device: ConvaTec Sensi-Care Protective BarrierMarketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum. |
Who may qualify
- Ages
- 1 hour and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects may be enrolled into this study if the answers to all these questions are yes.
- Is the subject a full-term newborn (36 weeks or greater gestational age) or older?
- Is the subject in a facility providing nursing care 24 hours per day?
- Does the subject have severe Category 2 Incontinence-Associated Dermatitis (IAD) -red with skin breakdown (i.e. skin erosion and denudation or denudation of skin alone)?
- Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of photographs in potential publication?
Key exclusion criteria (13 listed)
- Subjects are excluded from participation in this study if any of the answers to these following questions is yes.
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 ProtectantThe liquid barrier film flows from the applicator and dries quickly on the skin. It is durable for 72-96 hours under conditions of incontinence. | Device | Cavilon Advanced Skin Protectant |
| ConvaTec Sensi-Care Protective BarrierSensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence. | Device | ConvaTec Sensi-Care Protective Barrier |
Primary outcome
Percent Change From Baseline to End of Study in Incontinence Associated Dermatitis (IAD) Scores
Time frame: up to 21 days depending on length of hospitalization
Primary endpoint was percent decrease in Incontinence Associated Dermatitis (IAD) score from baseline to end of subject's participation. A negative value indicates increased IAD score; a positive value indicates decreased IAD score. IAD scores were calculated for 6 anatomical zones for color, presence of lesions, and skin loss using 3M's Skin Condition Assessment Tool. Skin condition assessed for 1) epidermal loss depth \& area involved; 2) skin color intact skin \& % area if not normal color. Intensity scored based on % area involved. Epidermal loss intensity rating scores ranged from 0 (none) - 4 (76-100%) partial (skin open, not weeping) or complete (skin open \& weeping). Color of intact skin rating scores ranged from 0 (skin color normal) - 4 (76-100%) skin color pink or red. Scores for each of the 6 body zones were combined to obtain a single IAD score for each subject. IAD scores ranged from 0 (best) - 720 (worst).
3 secondary outcomes
Re-epithelialization to a Category 1 or Lower
Time frame: Up to 21 days depending on length of hospitalization
Pain Scores During Incontinence Management
Time frame: Up to 21 days depending on length of hospitalization
Prevention of IAD.
Time frame: Measured at study day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Pat Parks, MD study director
3M
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cavilon Advanced Skin Protectant and ConvaTec Sensi-Care Protective Barrier in people with Incontinence Associated Dermatitis, run by Solventum US LLC at 10 sites in United States.
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 8 inclusion and 13 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 12 Oct 2018). 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?
Percent Change From Baseline to End of Study in Incontinence Associated Dermatitis (IAD) Scores (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 Oct 2024.