- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03057132
Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
May 13, 2019 updated by: 3M
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19124
- Eastern Regional Medical Center, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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?
Exclusion Criteria:
- 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?
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cavilon Advanced Skin Protectant
|
Cavilon Advanced Skin Protectant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline, 3 days
|
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.
|
Baseline, 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Matthew Cooper, MD, 3M
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
January 9, 2017
First Submitted That Met QC Criteria
February 15, 2017
First Posted (Actual)
February 17, 2017
Study Record Updates
Last Update Posted (Actual)
June 4, 2019
Last Update Submitted That Met QC Criteria
May 13, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLIN-PROT-ICH-US-05-274494
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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ConvaTec Inc.Completed
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The Hospital for Sick ChildrenTerminated
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Carilion ClinicVirginia Polytechnic Institute and State UniversityNot yet recruitingOstomy | Leakage | 3D Printing
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Coloplast A/SCompletedOstomy - Ileostomy or ColostomyUnited Kingdom, Netherlands
Clinical Trials on Cavilon Advanced Skin Protectant
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3MTerminatedIncontinence-associated DermatitisGermany, United Kingdom, Belgium
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University Ghent3MRecruitingWound of Skin | Irritant Dermatitis | Stoma Site DermatitisBelgium
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Mayo ClinicCompletedRadiation DermatitisUnited States
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3MTerminatedIncontinence Associated DermatitisUnited States
-
Tan Tock Seng HospitalTerminatedIncontinence-associated DermatitisSingapore
-
Charite University, Berlin, GermanyRecruiting
-
Medline IndustriesEnrolling by invitationErythema | Skin Folds | Lesion Skin | MacerationUnited States