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

NCT02724449 | Completed Results

• 1 other identifier: 14-348
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dermatitis

Keywords

IAD; Fecal incontinence

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and end of treatment (up to 3 weeks)

Study Arms (1)

Cavilon Advanced Barrier Film

EXPERIMENTAL

Cavilon Advanced Barrier Film applied to areas of IAD

Device: Cavilon Advanced Barrier Film

Interventions

Cavilon Advanced Barrier Film DEVICE

Cavilon Advanced Barrier Fim's application applied twice a week

Cavilon Advanced Barrier Film

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years or older

You may not qualify if:

• 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?

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Related Publications (3)

• 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.

  PMID: 22193141 RESULT

• 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.

  PMID: 22572899 RESULT

• 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.

  PMID: 19374674 RESULT

MeSH Terms

Conditions

Dermatitis; Fecal Incontinence

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Mary Brennan, Assist Director WOCN
• Organization: North Shore University Hospital

mbrennan@northwell.edu

516-562-8252

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: March 31, 2016
• Study Start: August 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 17, 2024
• Results First Posted: June 9, 2017

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share