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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057132
Recruitment Status : Terminated (Slow enrollment of patients)
First Posted : February 17, 2017
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
3M

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.

Condition or disease Intervention/treatment Phase
Ostomy Device: Cavilon Advanced Skin Protectant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open label no masking required
Primary Purpose: Supportive Care
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
Actual Study Start Date : November 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas Ostomy

Arm Intervention/treatment
Experimental: Cavilon Advanced Skin Protectant
Cavilon Advanced Skin Protectant
Device: Cavilon Advanced Skin Protectant
Cavilon Advanced Skin Protectant




Primary Outcome Measures :
  1. 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.


  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is the subject 18 years of age or older?
  2. 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?
  3. Is the subject willing to have photographs taken of their skin and permit use of photographs in potential publication?
  4. Is the subject willing to release rights to 3M for the use of the photos?
  5. 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?
  6. 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:

  1. If female, is the subject pregnant or breast feeding or has she given birth within the 3 weeks preceding the screening visit?
  2. Does the subject have a known allergy to acrylates or cyanoacrylates?
  3. Does the subject have a preexisting skin disease on the areas affected that may make skin assessments for this study difficult?
  4. Does the skin area affected require treatment with a concomitant medication or product?
  5. Has the subject received antifungal powders in the area affected within 24 hours prior to enrollment?
  6. Has the subject received cyanoacrylate based skin protectant (such as Marathon) within 72 hours prior to enrollment?
  7. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
  8. Has the subject been enrolled in any investigational study where product was applied to proposed study sites within 30 days of the screening visit?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057132


Locations
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United States, Pennsylvania
Eastern Regional Medical Center, Inc.
Philadelphia, Pennsylvania, United States, 19124
Sponsors and Collaborators
3M
Investigators
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Study Director: Matthew Cooper, MD 3M
  Study Documents (Full-Text)

Documents provided by 3M:
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Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT03057132    
Other Study ID Numbers: CLIN-PROT-ICH-US-05-274494
First Posted: February 17, 2017    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fistula
Pathological Conditions, Anatomical
Protective Agents
Physiological Effects of Drugs