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A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)

Primary Purpose

Dermatitis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Cavilon Advanced Barrier Film

About this trial

This is an interventional prevention trial for Dermatitis focused on measuring IAD, Fecal incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Is the subject 18 years of age or older?
Is the subject in a facility providing nursing care 24h per day?
Does the subject have severe incontinence-associated dermatitis eg breached or denuded skin? The ideal candidate would have denudement present.
Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of the photos in potential publications?
Is the subject willing to release rights to 3M for use of the photos?
Has the subject signed an Institutional Review Board-approved informed consent document and authorized the use and disclosure of protected health information? At NS-LIJ, only subjects who are capable of consenting are eligible to enroll. The study will not include participants with decisional impairment that would render them incapable of informed consent.

18 years or older

Exclusion Criteria:

Subjects are excluded from participation in this study if any of the answers to these questions is yes.

If female, is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
Does the subject have a known allergy to acrylates or cyanoacrylate?
Does the subject have a current pressure ulcer in the area where the skin is affected by incontinence?
Does the subject have an active genital herpes infection?
Does the subject have a pre-existing abnormal skin disease on the treatment areas that may affect skin assessment?
Does the skin area involved in this study require treatment with a concomitant medication or product?
Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?
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 received antifungal powders within 24 hours prior to enrollment?
Has the subject received cyanoacrylate based skin protectant to the affected areas (such as Marathon) within 72 hours prior to enrollment?
Is the facility unwilling to discontinue use for this subject of Dimethicone containing wipes on the area where the investigational device will be applied?
Is the facility unwilling to discontinue use for this subject of Chlorhexidine Gluconate wipes on the area where the investigational device will be applied?

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cavilon Advanced Barrier Film

Arm Description

Cavilon Advanced Barrier Film applied to areas of IAD

Outcomes

Primary Outcome Measures

Number of Participants With Change in Incontinence Associated Dermatitis Score

Patients who were experiencing Incontinence Associated Dermatitis (IAD) from exposure to urine, stool or a combination of both urine & stool received an application of the barrier film every 72 hours. A skin assessment tool designed for IAD was used to document each patient's IAD score over time. The area scored was divided into 6 zones, l & r buttocks, L & right thighs, perianal & gluteal cleft. The % area within each zone with denudement was X by 9, redness was X by 3 and healthy skin X 1. The total score range of the 6 zones was 0-3654 with 3654 being worst case scenario. Improvement of IAD Score - At baseline (enrollment) the six zones were evaluated for % of denudement, redness, pink and healthy skin assessed. At the end of subject's participation, assessment were completed again to determine final score & change for improvement was measured by reduction in IAD score No improvement of IAD score - No change in score Progression of IAD score - Increase in IAD score

Secondary Outcome Measures

Full Information

NCT ID

NCT02724449

First Posted

May 28, 2015

Last Updated

May 11, 2017

Sponsor

1. Study Identification

Unique Protocol Identification Number

NCT02724449

Brief Title

A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)

Official Title

A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to obtain information concerning the safety and effective use of a protective barrier film in patients experiencing severe incontinence associated dermatitis.

Detailed Description

This is an open label, non randomized prospective case series evaluating 3M Cavilon Advanced Barrier Film for the treatment of severe incontinence associated dermatitis (IAD) in the presence or absence of continued fecal or fecal and urinary incontinence. The product will be applied twice a week for a maximum duration of 3 weeks. Subjects will be followed twice a week until healing, for a maximum of 3 weeks or earlier, if discharged from the facility. During the study period, the frequency and intensity of their incontinence will be monitored, twice a week photographic documentation and IAD site assessments will be completed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis

Keywords

IAD, Fecal incontinence

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cavilon Advanced Barrier Film

Arm Type

Experimental

Arm Description

Cavilon Advanced Barrier Film applied to areas of IAD

Intervention Type

Device

Intervention Name(s)

Cavilon Advanced Barrier Film

Intervention Description

Cavilon Advanced Barrier Fim's application applied twice a week

Primary Outcome Measure Information:

Title

Number of Participants With Change in Incontinence Associated Dermatitis Score

Description

Time Frame

Baseline and end of treatment (up to 3 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Is the subject 18 years of age or older? Is the subject in a facility providing nursing care 24h per day? Does the subject have severe incontinence-associated dermatitis eg breached or denuded skin? The ideal candidate would have denudement present. Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of the photos in potential publications? Is the subject willing to release rights to 3M for use of the photos? Has the subject signed an Institutional Review Board-approved informed consent document and authorized the use and disclosure of protected health information? At NS-LIJ, only subjects who are capable of consenting are eligible to enroll. The study will not include participants with decisional impairment that would render them incapable of informed consent. 18 years or older Exclusion Criteria: Subjects are excluded from participation in this study if any of the answers to these questions is yes. If female, is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit? Does the subject have a known allergy to acrylates or cyanoacrylate? Does the subject have a current pressure ulcer in the area where the skin is affected by incontinence? Does the subject have an active genital herpes infection? Does the subject have a pre-existing abnormal skin disease on the treatment areas that may affect skin assessment? Does the skin area involved in this study require treatment with a concomitant medication or product? Has the subject been enrolled in any investigational study within 30 days of the Screening Visit? 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 received antifungal powders within 24 hours prior to enrollment? Has the subject received cyanoacrylate based skin protectant to the affected areas (such as Marathon) within 72 hours prior to enrollment? Is the facility unwilling to discontinue use for this subject of Dimethicone containing wipes on the area where the investigational device will be applied? Is the facility unwilling to discontinue use for this subject of Chlorhexidine Gluconate wipes on the area where the investigational device will be applied?

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22193141

Citation

Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, Selekof J, Doughty D, Kurz P. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):61-74. doi: 10.1097/WON.0b013e31823fe246.

Results Reference

result

PubMed Identifier

22572899

Citation

Doughty D, Junkin J, Kurz P, Selekof J, Gray M, Fader M, Bliss DZ, Beeckman D, Logan S. Incontinence-associated dermatitis: consensus statements, evidence-based guidelines for prevention and treatment, and current challenges. J Wound Ostomy Continence Nurs. 2012 May-Jun;39(3):303-15; quiz 316-7. doi: 10.1097/WON.0b013e3182549118.

Results Reference

result

PubMed Identifier

19374674

Citation

Beeckman D, Schoonhoven L, Verhaeghe S, Heyneman A, Defloor T. Prevention and treatment of incontinence-associated dermatitis: literature review. J Adv Nurs. 2009 Jun;65(6):1141-54. doi: 10.1111/j.1365-2648.2009.04986.x. Epub 2009 Apr 3.

Results Reference

result

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A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)

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