Trial Outcomes & Findings for A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD) (NCT NCT02724449)
NCT ID: NCT02724449
Last Updated: 2024-12-17
Results Overview
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
COMPLETED
NA
16 participants
Baseline and end of treatment (up to 3 weeks)
2024-12-17
Participant Flow
Participant milestones
| Measure |
Open-label Study
No competitive products evaluated.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)
Baseline characteristics by cohort
| Measure |
Cavilon Advanced Barrier Film
n=16 Participants
Cavilon Advanced Barrier Film applied to areas of IAD
Cavilon Advanced Barrier Film: Cavilon Advanced Barrier Fim's application applied twice a week
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
70.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (up to 3 weeks)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
Outcome measures
| Measure |
Open Label Study
n=16 Participants
|
|---|---|
|
Number of Participants With Change in Incontinence Associated Dermatitis Score
Improved IAD score
|
13 participants
|
|
Number of Participants With Change in Incontinence Associated Dermatitis Score
No improvement of IAD score
|
1 participants
|
|
Number of Participants With Change in Incontinence Associated Dermatitis Score
Worsening of IAD score
|
2 participants
|
Adverse Events
Open-label Study
Serious adverse events
| Measure |
Open-label Study
n=16 participants at risk
Single arm study
|
|---|---|
|
Cardiac disorders
MI
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
full thickness wound
|
6.2%
1/16 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Mary Brennan, Assist Director WOCN
North Shore University Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place