Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study Evaluating the Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula

Conditions
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Ostomy

Intervention / Treatment
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* Device: Cavilon Advanced Skin Protectant


Participation Criteria
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Eligibility Criteria
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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?

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cavilon Advanced Skin Protectant<br>Cavilon Advanced Skin Protectant | Device: Cavilon Advanced Skin Protectant<br>* Cavilon Advanced Skin Protectant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, 3 days |