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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
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.
Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
Children's Hospitals and Clinic
Minneapolis, Minnesota, United States
Children's Hospital and Clinics
Saint Paul, Minnesota, United States
Good Samaritan
Kearney, Nebraska, United States
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).
Time frame: up to 21 days depending on length of hospitalization
Re-epithelialization to a Category 1 or Lower
Looking for healing of denuded skin to re-epithelialized skin.
Time frame: Up to 21 days depending on length of hospitalization
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.
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St. Elizabeth
Lincoln, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
Lennox Hill
New York, New York, United States
St. John
Tulsa, Oklahoma, United States
Roper St. Francis
Charleston, South Carolina, United States
Baylor Plano
Plano, Texas, United States
Time frame: Up to 21 days depending on length of hospitalization
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.
Time frame: Measured at study day 5