Back to resultsUse of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
Primary Purpose
Ostomy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cavilon Advanced Skin Protectant
Sponsored by
About this trial
This is an interventional supportive care trial for Ostomy
Eligibility Criteria
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?
Sites / Locations
- Eastern Regional Medical Center, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cavilon Advanced Skin Protectant
Arm Description
Cavilon Advanced Skin Protectant
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03057132
Brief Title
Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment of patients
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ostomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open label no masking required
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cavilon Advanced Skin Protectant
Arm Type
Experimental
Arm Description
Cavilon Advanced Skin Protectant
Intervention Type
Device
Intervention Name(s)
Cavilon Advanced Skin Protectant
Intervention Description
Cavilon Advanced Skin Protectant
Primary Outcome Measure Information:
Title
Percent of Epidermal Skin Loss at the Primary Site Assessed
Description
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.
Time Frame
Baseline, 3 days
Title
Pain Scores at the Primary Site Assessed
Description
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.
Time Frame
Baseline, 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Cooper, MD
Organizational Affiliation
3M
Official's Role
Study Director
Facility Information:
Facility Name
Eastern Regional Medical Center, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
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