Back to resultsClinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontinence & Allow Healing
Primary Purpose
Incontinence Associated Dermatitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cavilon Advanced Skin Protectant
ConvaTec Sensi-Care Protective Barrier
Sponsored by
About this trial
This is an interventional treatment trial for Incontinence Associated Dermatitis
Eligibility Criteria
Inclusion Criteria:
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?
Exclusion Criteria:
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?
Sites / Locations
- Children's Hospitals and Clinic
- Children's Hospital and Clinics
- Good Samaritan
- St. Elizabeth
- Hackensack University Medical Center
- North Shore University Hospital
- Lennox Hill
- St. John
- Roper St. Francis
- Baylor Plano
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cavilon Advanced Skin Protectant
ConvaTec Sensi-Care Protective Barrier
Arm Description
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Re-epithelialization to a Category 1 or Lower
Looking for healing of denuded skin to re-epithelialized skin.
Pain Scores During Incontinence Management
Pain scores during incontinence management were measured on a 0-10 scale, and analyzed only for subjects from the intent-to-treat dataset who could report pain. Adult pain was measured on 0-10 Wong-Baker FACES® Pain Scale Visual Analog to see if there is pain reduction (0 - no pain; 10 - worst pain). Pain in pediatric patients was measured with the 0-10 FLACC (Face, Legs, Activity, Cry, Consolability Behavioral) Tool. FLACC tool scores pain based on 5 categories, each scored on 0-2 scale and a total score calculated from the sum of the 5 categories for a total possible 0 (no pain) - 10 (worst pain) score. Data from the 2 scales were combined for analysis. Reduction in pain scores collected during product application were reported and least squares means adjusted for baseline pain score as a covariate were calculated. Negative value indicates reduction in pain score; positive value indicates increased pain score.
Prevention of IAD.
Number of subjects with areas of buttock and thighs that were free of IAD at baseline and remained free of damage with ongoing incontinence through 5 days of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02570139
Brief Title
Clinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontinence & Allow Healing
Official Title
Multi-Center, Randomized Trial Comparing the Efficacy of 3M™ Cavilon™ Advanced Barrier Film for the Treatment of Incontinence-associated Dermatitis to a Commercially Available Moisture Barrier
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment, short stay; lacked statistically powered evaluation for efficacy.
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 23, 2017 (Actual)
Study Completion Date
June 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The purpose of this study is to evaluated the product performance of a new skin protectant formulated to protect damaged and denuded skin even in the presence of exposure to the most potentially damaging body fluids, such as liquid stool and gastric fluid. The product is expected to intimately adhere to damaged and denuded skin and provide better protection from further damage than commonly used products such as moisture barrier pastes, thereby making it easier for nursing staff to cleanse the skin after incontinence episodes, thus saving time and also materials.
The denuded sites on buttocks/thighs will be scored for skin loss and degree of redness. Over the course of time, with the skin protected, it should re-epithelizes. The skin improvement will be scored and the change in baseline over time monitored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence Associated Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cavilon Advanced Skin Protectant
Arm Type
Experimental
Arm Description
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Arm Title
ConvaTec Sensi-Care Protective Barrier
Arm Type
Active Comparator
Arm Description
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.
Intervention Type
Device
Intervention Name(s)
Cavilon Advanced Skin Protectant
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ConvaTec Sensi-Care Protective Barrier
Intervention Description
Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
Primary Outcome Measure Information:
Title
Percent Change From Baseline to End of Study in Incontinence Associated Dermatitis (IAD) Scores
Description
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).
Time Frame
up to 21 days depending on length of hospitalization
Secondary Outcome Measure Information:
Title
Re-epithelialization to a Category 1 or Lower
Description
Looking for healing of denuded skin to re-epithelialized skin.
Time Frame
Up to 21 days depending on length of hospitalization
Title
Pain Scores During Incontinence Management
Description
Pain scores during incontinence management were measured on a 0-10 scale, and analyzed only for subjects from the intent-to-treat dataset who could report pain. Adult pain was measured on 0-10 Wong-Baker FACES® Pain Scale Visual Analog to see if there is pain reduction (0 - no pain; 10 - worst pain). Pain in pediatric patients was measured with the 0-10 FLACC (Face, Legs, Activity, Cry, Consolability Behavioral) Tool. FLACC tool scores pain based on 5 categories, each scored on 0-2 scale and a total score calculated from the sum of the 5 categories for a total possible 0 (no pain) - 10 (worst pain) score. Data from the 2 scales were combined for analysis. Reduction in pain scores collected during product application were reported and least squares means adjusted for baseline pain score as a covariate were calculated. Negative value indicates reduction in pain score; positive value indicates increased pain score.
Time Frame
Up to 21 days depending on length of hospitalization
Title
Prevention of IAD.
Description
Number of subjects with areas of buttock and thighs that were free of IAD at baseline and remained free of damage with ongoing incontinence through 5 days of treatment.
Time Frame
Measured at study day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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?
Exclusion Criteria:
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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pat Parks, MD
Organizational Affiliation
3M
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospitals and Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Children's Hospital and Clinics
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Good Samaritan
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68848
Country
United States
Facility Name
St. Elizabeth
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
76010
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Lennox Hill
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
St. John
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Roper St. Francis
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontinence & Allow Healing
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