OstomyNCT03057132
Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
A study testing Cavilon Advanced Skin Protectant in people with Ostomy, run by Solventum US LLC at 1 site in United States.
Trial summary
The objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3M™ Cavilon™ Advanced Skin Protectant when used in the management of damaged skin exposed to caustic body fluids from an ostomy, drain site or fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy
- 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
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is the subject 18 years of age or older?
- Does the subject have red skin with breakdown (i.e. skin erosion and denudation or denudation of skin alone) at the primary site of an ostomy, drain and/or fistula?
- Is the subject willing to have photographs taken of their skin 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 be in the hospital or available for follow-up visits during the 14 day study period?
- Has the subject signed an Institutional Review Board-approved informed consent/assent document and authorized the use and disclosure of protected health information?
Who cannot join
- 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 preexisting skin disease on the areas affected that may make skin assessments for this study difficult?
- Does the skin area affected require treatment with a concomitant medication or product?
- Has the subject received antifungal powders in the area affected within 24 hours prior to enrollment?
- Has the subject received cyanoacrylate based skin protectant (such as Marathon) within 72 hours prior to enrollment?
- 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
1 site in 1 country.
United States1 site
Eastern Regional Medical Center, Inc.
Philadelphia, Pennsylvania, 19124
About this study
Official title: A Pilot Study Evaluating the Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
The objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3M™ Cavilon™ Advanced Skin Protectant when used in the management of damaged skin exposed to caustic body fluids from an ostomy, drain site or fistula.
Read the detailed description
This is a pilot study evaluating the product, 3M™ Cavilon™ Advanced Skin Protectant, for the management of skin around an ostomy, drain and/or fistula. All subjects will receive the product for up to 14 days. The primary site must have red skin with breakdown (i.e. skin erosion and denudation or denudation of skin alone). Secondary sites can have red skin with or without breakdown. Product will be applied twice/week or more frequently if additional applications are needed due to leakage, skin irritation or standard of care. Skin assessments (including photography) will be completed at baseline and at all follow-up visits.
- Conditions
- Ostomy
- Being tested
- Cavilon Advanced Skin Protectant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cavilon Advanced Skin ProtectantDevice
Cavilon Advanced Skin Protectant
| Study group | Role | What they receive |
|---|---|---|
| Cavilon Advanced Skin Protectant | Experimental | Cavilon Advanced Skin Protectant Receives: Device: Cavilon Advanced Skin Protectant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Epidermal Skin Loss at the Primary Site Assessed
The primary endpoint is the improvement of denuded skin (defined as clinical improvement from the baseline skin assessment) of the primary site of interest (ostomy).
The primary response was the percent of skin at primary site of interest with epidermal loss observed at baseline and at 3 days post product application.
Measured: Baseline, 3 days
Pain Scores at the Primary Site Assessed
Improvement in pain from baseline to the end of the study. The Wong-Baker FACES® Pain Visual Analog Pain Scale was used to assess pain at each time point. Pain was assessed on a 0 (no pain) to 10 (worst pain) grading scale. Lower score is better.
Measured: Baseline, 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startNov 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Slow enrollment of patients
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 OstomyStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Matthew Cooper, MD, Study director, 3M
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057132
- Sponsor's protocol ID
- CLIN-PROT-ICH-US-05-274494
- Status last verified
- Nov 2024
- First submitted
- 9 Jan 2017
- Last updated
- 2 Dec 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
- ClinicalTrials.gov ID
- NCT03057132
- Acronym / sponsor ID
- CLIN-PROT-ICH-US-05-274494
- Conditions
- Ostomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment of patients
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Nov 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3M™ Cavilon™ Advanced Skin Protectant when used in the management of damaged skin exposed to caustic body fluids from an ostomy, drain site or fistula.
Detailed description
This is a pilot study evaluating the product, 3M™ Cavilon™ Advanced Skin Protectant, for the management of skin around an ostomy, drain and/or fistula. All subjects will receive the product for up to 14 days. The primary site must have red skin with breakdown (i.e. skin erosion and denudation or denudation of skin alone). Secondary sites can have red skin with or without breakdown. Product will be applied twice/week or more frequently if additional applications are needed due to leakage, skin irritation or standard of care. Skin assessments (including photography) will be completed at baseline and at all follow-up visits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cavilon Advanced Skin Protectant | Experimental | Device: Cavilon Advanced Skin ProtectantCavilon Advanced Skin Protectant |
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 subject 18 years of age or older?
- Does the subject have red skin with breakdown (i.e. skin erosion and denudation or denudation of skin alone) at the primary site of an ostomy, drain and/or fistula?
- Is the subject willing to have photographs taken of their skin 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 be in the hospital or available for follow-up visits during the 14 day study period?
Key exclusion criteria (8 listed)
- 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 preexisting skin disease on the areas affected that may make skin assessments for this study difficult?
- Does the skin area affected require treatment with a concomitant medication or product?
- Has the subject received antifungal powders in the area affected within 24 hours prior to enrollment?
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 ProtectantCavilon Advanced Skin Protectant | Device | Cavilon Advanced Skin Protectant |
Primary outcome
Percent of Epidermal Skin Loss at the Primary Site Assessed
Time frame: Baseline, 3 days
The primary endpoint is the improvement of denuded skin (defined as clinical improvement from the baseline skin assessment) of the primary site of interest (ostomy). The primary response was the percent of skin at primary site of interest with epidermal loss observed at baseline and at 3 days post product application.
Pain Scores at the Primary Site Assessed
Time frame: Baseline, 3 days
Improvement in pain from baseline to the end of the study. The Wong-Baker FACES® Pain Visual Analog Pain Scale was used to assess pain at each time point. Pain was assessed on a 0 (no pain) to 10 (worst pain) grading scale. Lower score is better.
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.
- Individual participant dataSharing planned: No
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The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
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Novel Post-Surgical Incision Management to Prevent Ostomy Complications
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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.
Matthew Cooper, MD study director
3M
1 site 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 in people with Ostomy, run by Solventum US LLC at 1 site 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 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 1 site 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 4 Jun 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?
Percent of Epidermal Skin Loss at the Primary Site Assessed (time frame: Baseline, 3 days). 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?
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.