Trial Outcomes & Findings for Clinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontinence & Allow Healing (NCT NCT02570139)
NCT ID: NCT02570139
Last Updated: 2024-10-02
Results Overview
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).
TERMINATED
NA
45 participants
up to 21 days depending on length of hospitalization
2024-10-02
Participant Flow
Participant milestones
| Measure |
Cavilon Advanced Skin Protectant
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Cavilon Advanced Skin Protectant: 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.
|
ConvaTec Sensi-Care Protective Barrier
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.
ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
|
Overall Study
COMPLETED
|
24
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The age distribution is between years for adults
Baseline characteristics by cohort
| Measure |
Cavilon Advanced Skin Protectant
n=24 Participants
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Cavilon Advanced Skin Protectant: The liquid barrier film flows from the applicator and dries quickly on the skin.
|
ConvaTec Sensi-Care Protective Barrier
n=21 Participants
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.
ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Years
|
67.1 years or weeks
STANDARD_DEVIATION 19.33 • n=21 Participants • The age distribution is between years for adults
|
62.1 years or weeks
STANDARD_DEVIATION 19.97 • n=18 Participants • The age distribution is between years for adults
|
64.8 years or weeks
STANDARD_DEVIATION 19.54 • n=39 Participants • The age distribution is between years for adults
|
|
Age, Customized
Weeks
|
11.3 Weeks
STANDARD_DEVIATION 7.37 • n=3 Participants • the discrepancy in overall number of baseline patients is due to revised age of the pediatric patients (in weeks) vs adult population (years). The total number of participants is unchanged.
|
20.3 Weeks
STANDARD_DEVIATION 4.51 • n=3 Participants • the discrepancy in overall number of baseline patients is due to revised age of the pediatric patients (in weeks) vs adult population (years). The total number of participants is unchanged.
|
15.8 Weeks
STANDARD_DEVIATION 7.36 • n=6 Participants • the discrepancy in overall number of baseline patients is due to revised age of the pediatric patients (in weeks) vs adult population (years). The total number of participants is unchanged.
|
|
Sex: Female, Male
Female
|
10 Participants
n=24 Participants
|
9 Participants
n=21 Participants
|
19 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=24 Participants
|
12 Participants
n=21 Participants
|
26 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=24 Participants
|
21 Participants
n=21 Participants
|
41 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=24 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=24 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=24 Participants
|
18 Participants
n=21 Participants
|
35 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=45 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
21 participants
n=21 Participants
|
45 participants
n=45 Participants
|
PRIMARY outcome
Timeframe: up to 21 days depending on length of hospitalizationPopulation: Analysis was done using the intent-to-treat (ITT) population, using all subjects who had at least one dose of their assigned product.
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).
Outcome measures
| Measure |
Cavilon Advanced Skin Protectant
n=24 Participants
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Cavilon Advanced Skin Protectant: 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.
|
ConvaTec Sensi-Care Protective Barrier
n=21 Participants
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.
ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
|
|---|---|---|
|
Percent Change From Baseline to End of Study in Incontinence Associated Dermatitis (IAD) Scores
|
11.0 percentage change
Standard Error 13.2
|
34.3 percentage change
Standard Error 14.1
|
SECONDARY outcome
Timeframe: Up to 21 days depending on length of hospitalizationPopulation: Review and analysis of healing of denuded skin to re-epithelialization.
Looking for healing of denuded skin to re-epithelialized skin.
Outcome measures
| Measure |
Cavilon Advanced Skin Protectant
n=25 Participants
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Cavilon Advanced Skin Protectant: 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.
|
ConvaTec Sensi-Care Protective Barrier
n=21 Participants
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.
ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
|
|---|---|---|
|
Re-epithelialization to a Category 1 or Lower
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 21 days depending on length of hospitalizationPopulation: The patient population analyzed were those who could report pain
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.
Outcome measures
| Measure |
Cavilon Advanced Skin Protectant
n=13 Participants
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Cavilon Advanced Skin Protectant: 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.
|
ConvaTec Sensi-Care Protective Barrier
n=11 Participants
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.
ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
|
|---|---|---|
|
Pain Scores During Incontinence Management
|
-0.7 Change in Score on 0-10 Scale
Standard Error 0.8
|
0.3 Change in Score on 0-10 Scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Measured at study day 5Population: This is the population who went thru 5 days
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.
Outcome measures
| Measure |
Cavilon Advanced Skin Protectant
n=9 Participants
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Cavilon Advanced Skin Protectant: 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.
|
ConvaTec Sensi-Care Protective Barrier
n=7 Participants
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.
ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
|
|---|---|---|
|
Prevention of IAD.
|
8 Participants
|
4 Participants
|
Adverse Events
Cavilon Advanced Skin Protectant
ConvaTec Sensi-Care Protective Barrier
Serious adverse events
| Measure |
Cavilon Advanced Skin Protectant
n=24 participants at risk
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Cavilon Advanced Skin Protectant: 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.
|
ConvaTec Sensi-Care Protective Barrier
n=21 participants at risk
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.
ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
|
|---|---|---|
|
Gastrointestinal disorders
Gi Bleed
|
0.00%
0/24 • Adverse event data was captured for 1 year, 9 months.
|
4.8%
1/21 • Adverse event data was captured for 1 year, 9 months.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/24 • Adverse event data was captured for 1 year, 9 months.
|
4.8%
1/21 • Adverse event data was captured for 1 year, 9 months.
|
|
Vascular disorders
Non-occlusive thombosis
|
0.00%
0/24 • Adverse event data was captured for 1 year, 9 months.
|
4.8%
1/21 • Adverse event data was captured for 1 year, 9 months.
|
Other adverse events
| Measure |
Cavilon Advanced Skin Protectant
n=24 participants at risk
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Cavilon Advanced Skin Protectant: 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.
|
ConvaTec Sensi-Care Protective Barrier
n=21 participants at risk
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.
ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
fungal infection
|
8.3%
2/24 • Adverse event data was captured for 1 year, 9 months.
|
9.5%
2/21 • Adverse event data was captured for 1 year, 9 months.
|
|
Skin and subcutaneous tissue disorders
Eczematous eruptions on back/arms
|
0.00%
0/24 • Adverse event data was captured for 1 year, 9 months.
|
4.8%
1/21 • Adverse event data was captured for 1 year, 9 months.
|
Additional Information
Anne Swearingen, Manager, Clinical Operations
3M Critical and Chronic Care Solutions Division
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place