Clinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontinence & Allow Healing

NCT02570139 | Terminated Results

• 1 other identifier: EM-05-012990
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of the investigational product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of incontinence associated dermatitis.

Conditions

Incontinence Associated Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline to End of Study in Incontinence Associated Dermatitis (IAD) Scores

  Primary endpoint was percent decrease in Incontinence Associated Dermatitis (IAD) score from baseline to end of subject's participation. A negative value indicates increased IAD score; a positive value indicates decreased IAD score. IAD scores were calculated for 6 anatomical zones for color, presence of lesions, and skin loss using 3M's Skin Condition Assessment Tool. Skin condition assessed for 1) epidermal loss depth \& area involved; 2) skin color intact skin \& % area if not normal color. Intensity scored based on % area involved. Epidermal loss intensity rating scores ranged from 0 (none) - 4 (76-100%) partial (skin open, not weeping) or complete (skin open \& weeping). Color of intact skin rating scores ranged from 0 (skin color normal) - 4 (76-100%) skin color pink or red. Scores for each of the 6 body zones were combined to obtain a single IAD score for each subject. IAD scores ranged from 0 (best) - 720 (worst).

  up to 21 days depending on length of hospitalization

Secondary Outcomes (3)

• Re-epithelialization to a Category 1 or Lower

  Up to 21 days depending on length of hospitalization

• Pain Scores During Incontinence Management

  Up to 21 days depending on length of hospitalization

• Prevention of IAD.

  Measured at study day 5

Study Arms (2)

Cavilon Advanced Skin Protectant

EXPERIMENTAL

Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.

Device: Cavilon Advanced Skin Protectant

ConvaTec Sensi-Care Protective Barrier

ACTIVE COMPARATOR

Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.

Device: ConvaTec Sensi-Care Protective Barrier

Interventions

Cavilon Advanced Skin Protectant DEVICE

The liquid barrier film flows from the applicator and dries quickly on the skin. It is durable for 72-96 hours under conditions of incontinence.

Cavilon Advanced Skin Protectant

ConvaTec Sensi-Care Protective Barrier DEVICE

Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.

ConvaTec Sensi-Care Protective Barrier

Eligibility Criteria

• Age: 1 Hour+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects may be enrolled into this study if the answers to all these questions are yes.
• Is the subject a full-term newborn (36 weeks or greater gestational age) or older?
• Is the subject in a facility providing nursing care 24 hours per day?
• Does the subject have severe Category 2 Incontinence-Associated Dermatitis (IAD) -red with skin breakdown (i.e. skin erosion and denudation or denudation of skin alone)?
• Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of photographs in potential publication?
• Is the subject willing to release rights to 3M for the use of the photos?
• Is there a reasonable expectation that the subject will remain in a facility for at least 7 days following enrollment in the study?
• Has the subject, or their legally authorized representative, signed an Institutional Review Board-approved informed consent/assent document and authorized the use and disclosure of protected health information?

You may not qualify if:

• Subjects are excluded from participation in this study if any of the answers to these following questions is yes.
• If female, is the subject pregnant or breast feeding or has she given birth within the 3 weeks preceding the screening visit?
• Does the subject have a known allergy to acrylates or cyanoacrylates?
• Does the subject have a Stage III, IV, unstageable, suspected deep tissue injury pressure ulcer in the area where the skin is affected by incontinence?
• Does the subject have a preexisting skin disease on the areas affected by incontinence that may make skin assessments for this study difficult?
• Does the skin area affected by incontinence require treatment with a concomitant medication or product?
• Does the subject have an active genital herpes infection?
• Has the subject received antifungal powders in the area affected with IAD within 24 hours prior to enrollment?
• Has the subject received cyanoacrylate based skin protectant (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 skin protectant product will be applied?
• Is the facility unwilling to discontinue use for this subject of Chlorhexidine Gluconate wipes on the area where the skin protectant product will be applied?
• 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 been enrolled in any investigational study where product was applied to proposed study sites within 30 days of the screening visit?

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (10)

Children's Hospitals and Clinic

Minneapolis, Minnesota, 55404, United States

Location

Children's Hospital and Clinics

Saint Paul, Minnesota, 55102, United States

Location

Good Samaritan

Kearney, Nebraska, 68848, United States

Location

St. Elizabeth

Lincoln, Nebraska, 68510, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 76010, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Lennox Hill

New York, New York, 10075, United States

Location

St. John

Tulsa, Oklahoma, 74104, United States

Location

Roper St. Francis

Charleston, South Carolina, 29401, United States

Location

Baylor Plano

Plano, Texas, 75093, United States

Location

Results Point of Contact

• Title: Anne Swearingen, Manager, Clinical Operations
• Organization: 3M Critical and Chronic Care Solutions Division

aswearingen@mmm.com

651 736 7826

Study Officials

• Pat Parks, MD

  3M

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 7, 2015
• Study Start: October 1, 2015
• Primary Completion: June 23, 2017
• Study Completion: June 23, 2017
• Last Updated: October 2, 2024
• Results First Posted: October 12, 2018

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)