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

NCT ID: NCT03057132

Last Updated: 2024-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-02-28

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.

Conditions

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Ostomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Open label no masking required

Study Groups

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Cavilon Advanced Skin Protectant

Cavilon Advanced Skin Protectant

Group Type EXPERIMENTAL

Cavilon Advanced Skin Protectant

Intervention Type DEVICE

Cavilon Advanced Skin Protectant

Interventions

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Cavilon Advanced Skin Protectant

Cavilon Advanced Skin Protectant

Intervention Type DEVICE

Eligibility Criteria

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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?
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Cooper, MD

Role: STUDY_DIRECTOR

3M

Locations

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Eastern Regional Medical Center, Inc.

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CLIN-PROT-ICH-US-05-274494

Identifier Type: -

Identifier Source: org_study_id