DermatitisNCT02724449
A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)
A study testing Cavilon Advanced Barrier Film in people with Dermatitis, run by Solventum US LLC.
Trial summary
The purpose of this study is to obtain information concerning the safety and effective use of a protective barrier film in patients experiencing severe incontinence associated dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermatitis
- What is being tested?
- Cavilon Advanced Barrier Film
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Feb 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is the subject 18 years of age or older?
- Is the subject in a facility providing nursing care 24h per day?
- Does the subject have severe incontinence-associated dermatitis eg breached or denuded skin? The ideal candidate would have denudement present.
- Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of the photos in potential publications?
- Is the subject willing to release rights to 3M for use of the photos?
- Has the subject signed an Institutional Review Board-approved informed consent document and authorized the use and disclosure of protected health information? At NS-LIJ, only subjects who are capable of consenting are eligible to enroll. The study will not include participants with decisional impairment that would render them incapable of informed consent.
- 18 years or older
Who cannot join
- Subjects are excluded from participation in this study if any of the answers to these questions is yes.
- If female, is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
- Does the subject have a known allergy to acrylates or cyanoacrylate?
- Does the subject have a current pressure ulcer in the area where the skin is affected by incontinence?
- Does the subject have an active genital herpes infection?
- Does the subject have a pre-existing abnormal skin disease on the treatment areas that may affect skin assessment?
Show all 13Show fewer
- Does the skin area involved in this study require treatment with a concomitant medication or product?
- Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?
- 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 received antifungal powders within 24 hours prior to enrollment?
- Has the subject received cyanoacrylate based skin protectant to the affected areas (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 investigational device will be applied?
- Is the facility unwilling to discontinue use for this subject of Chlorhexidine Gluconate wipes on the area where the investigational device will be applied?
About this study
The purpose of this study is to obtain information concerning the safety and effective use of a protective barrier film in patients experiencing severe incontinence associated dermatitis.
Read the detailed description
This is an open label, non randomized prospective case series evaluating 3M Cavilon Advanced Barrier Film for the treatment of severe incontinence associated dermatitis (IAD) in the presence or absence of continued fecal or fecal and urinary incontinence. The product will be applied twice a week for a maximum duration of 3 weeks. Subjects will be followed twice a week until healing, for a maximum of 3 weeks or earlier, if discharged from the facility. During the study period, the frequency and intensity of their incontinence will be monitored, twice a week photographic documentation and IAD site assessments will be completed.
- Conditions
- Dermatitis
- Being tested
- Cavilon Advanced Barrier Film
- Keywords
- IAD, Fecal incontinence
- Medical subject headings
- Dermatitis, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cavilon Advanced Barrier FilmDevice
Cavilon Advanced Barrier Fim's application applied twice a week
| Study group | Role | What they receive |
|---|---|---|
| Cavilon Advanced Barrier Film | Experimental | Cavilon Advanced Barrier Film applied to areas of IAD Receives: Device: Cavilon Advanced Barrier Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Change in Incontinence Associated Dermatitis Score
Patients who were experiencing Incontinence Associated Dermatitis (IAD) from exposure to urine, stool or a combination of both urine \& stool received an application of the barrier film every 72 hours. A skin assessment tool designed for IAD was used to document each patient's IAD score over time. The area scored was divided into 6 zones, l \& r buttocks, L \& right thighs, perianal \& gluteal cleft. The % area within each zone with denudement was X by 9, redness was X by 3 and healthy skin X 1. The total score range of the 6 zones was 0-3654 with 3654 being worst case scenario.
Improvement of IAD Score - At baseline (enrollment) the six zones were evaluated for % of denudement, redness, pink and healthy skin assessed. At the end of subject's participation, assessment were completed again to determine final score \& change for improvement was measured by reduction in IAD score No improvement of IAD score - No change in score Progression of IAD score - Increase in IAD score
Measured: Baseline and end of treatment (up to 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724449
- Sponsor's protocol ID
- 14-348
- Status last verified
- Nov 2024
- First submitted
- 28 May 2015
- Last updated
- 17 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, Selekof J, Doughty D, Kurz P. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):61-74. doi: 10.1097/WON.0b013e31823fe246.
PubMed 22193141Doughty D, Junkin J, Kurz P, Selekof J, Gray M, Fader M, Bliss DZ, Beeckman D, Logan S. Incontinence-associated dermatitis: consensus statements, evidence-based guidelines for prevention and treatment, and current challenges. J Wound Ostomy Continence Nurs. 2012 May-Jun;39(3):303-15; quiz 316-7. doi: 10.1097/WON.0b013e3182549118.
PubMed 22572899Beeckman D, Schoonhoven L, Verhaeghe S, Heyneman A, Defloor T. Prevention and treatment of incontinence-associated dermatitis: literature review. J Adv Nurs. 2009 Jun;65(6):1141-54. doi: 10.1111/j.1365-2648.2009.04986.x. Epub 2009 Apr 3.
PubMed 19374674
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)
- ClinicalTrials.gov ID
- NCT02724449
- Acronym / sponsor ID
- 14-348
- Conditions
- Dermatitis
- Keywords
- IAD, Fecal incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Posted 9 Jun 2017
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 this study is to obtain information concerning the safety and effective use of a protective barrier film in patients experiencing severe incontinence associated dermatitis.
Detailed description
This is an open label, non randomized prospective case series evaluating 3M Cavilon Advanced Barrier Film for the treatment of severe incontinence associated dermatitis (IAD) in the presence or absence of continued fecal or fecal and urinary incontinence. The product will be applied twice a week for a maximum duration of 3 weeks. Subjects will be followed twice a week until healing, for a maximum of 3 weeks or earlier, if discharged from the facility. During the study period, the frequency and intensity of their incontinence will be monitored, twice a week photographic documentation and IAD site assessments will be completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cavilon Advanced Barrier Film | Experimental | Device: Cavilon Advanced Barrier FilmCavilon Advanced Barrier Film applied to areas of IAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is the subject 18 years of age or older?
- Is the subject in a facility providing nursing care 24h per day?
- Does the subject have severe incontinence-associated dermatitis eg breached or denuded skin? The ideal candidate would have denudement present.
- Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of the photos in potential publications?
- Is the subject willing to release rights to 3M for use of the photos?
Key exclusion criteria (13 listed)
- Subjects are excluded from participation in this study if any of the answers to these questions is yes.
- If female, is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
- Does the subject have a known allergy to acrylates or cyanoacrylate?
- Does the subject have a current pressure ulcer in the area where the skin is affected by incontinence?
- Does the subject have an active genital herpes infection?
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 Barrier FilmCavilon Advanced Barrier Fim's application applied twice a week | Device | Cavilon Advanced Barrier Film |
Primary outcome
Number of Participants With Change in Incontinence Associated Dermatitis Score
Time frame: Baseline and end of treatment (up to 3 weeks)
Patients who were experiencing Incontinence Associated Dermatitis (IAD) from exposure to urine, stool or a combination of both urine \& stool received an application of the barrier film every 72 hours. A skin assessment tool designed for IAD was used to document each patient's IAD score over time. The area scored was divided into 6 zones, l \& r buttocks, L \& right thighs, perianal \& gluteal cleft. The % area within each zone with denudement was X by 9, redness was X by 3 and healthy skin X 1. The total score range of the 6 zones was 0-3654 with 3654 being worst case scenario. Improvement of IAD Score - At baseline (enrollment) the six zones were evaluated for % of denudement, redness, pink and healthy skin assessed. At the end of subject's participation, assessment were completed again to determine final score \& change for improvement was measured by reduction in IAD score No improvement of IAD score - No change in score Progression of IAD score - Increase in IAD score
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22193141Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, Selekof J, Doughty D, Kurz P. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):61-74. doi: 10.1097/WON.0b013e31823fe246.
- Results publication: PubMed 22572899Doughty D, Junkin J, Kurz P, Selekof J, Gray M, Fader M, Bliss DZ, Beeckman D, Logan S. Incontinence-associated dermatitis: consensus statements, evidence-based guidelines for prevention and treatment, and current challenges. J Wound Ostomy Continence Nurs. 2012 May-Jun;39(3):303-15; quiz 316-7. doi: 10.1097/WON.0b013e3182549118.
- Results publication: PubMed 19374674Beeckman D, Schoonhoven L, Verhaeghe S, Heyneman A, Defloor T. Prevention and treatment of incontinence-associated dermatitis: literature review. J Adv Nurs. 2009 Jun;65(6):1141-54. doi: 10.1111/j.1365-2648.2009.04986.x. Epub 2009 Apr 3.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cavilon Advanced Barrier Film in people with Dermatitis, run by Solventum US LLC.
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 7 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: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 9 Jun 2017). 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 With Change in Incontinence Associated Dermatitis Score (time frame: Baseline and end of treatment (up to 3 weeks)). 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 NCT02724449, 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 2024.