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

Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724449
• Other study ID #: 14-348
• Status: Completed
• Phase: N/A
• First received: May 28, 2015
• Last updated: May 9, 2016
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Is the subject 18 years of age or older?

2. Is the subject in a facility providing nursing care 24h per day?

3. Does the subject have severe incontinence-associated dermatitis eg breached or denuded skin? The ideal candidate would have denudement present.

4. Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of the photos in potential publications?

5. Is the subject willing to release rights to 3M for use of the photos?

6. 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.

1. If female, is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?

2. Does the subject have a known allergy to acrylates or cyanoacrylate?

3. Does the subject have a current pressure ulcer in the area where the skin is affected by incontinence?

4. Does the subject have an active genital herpes infection?

5. Does the subject have a pre-existing abnormal skin disease on the treatment areas that may affect skin assessment?

6. Does the skin area involved in this study require treatment with a concomitant medication or product?

7. Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?

8. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?

9. Has the subject received antifungal powders within 24 hours prior to enrollment?

10. Has the subject received cyanoacrylate based skin protectant to the affected areas (such as Marathon) within 72 hours prior to enrollment?

11. Is the facility unwilling to discontinue use for this subject of Dimethicone containing wipes on the area where the investigational device will be applied?

12. Is the facility unwilling to discontinue use for this subject of Chlorhexidine Gluconate wipes on the area where the investigational device will be applied?

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dermatitis
• Eczema

Intervention

Device:
• Cavilon Advanced Barrier Film
Cavilon Advanced Barrier Fim's application applied twice a week

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	3M

References & Publications (3)

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. Review. — View 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 Nur — View 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. Rev — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 and stool received an application of the investigational barrier every 72 hours. A skin assessment tool designed for IAD was used to document each patient's IAD score over time.	3 weeks	No
Secondary	To improve comfort of the patient	Pain was assessed by patient who were able to speak using the FACES scale with scores of 0 (none) to 10 (severe)	3 weeks	No