Back to resultsClinical Case Series Evaluating Skin Wellness System
Primary Purpose
Moisture-associated Dermatitis, Fungal Infection in Perineal Area
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream
Sponsored by
About this trial
This is an interventional treatment trial for Moisture-associated Dermatitis focused on measuring Incontinence-associated dermatitis, Skin care regimen for moisture-associated conditions, Perineal skin care, Fungal infection in perineal area
Eligibility Criteria
Inclusion Criteria:
Adult subjects with any of the following indications:
- Erythema, maceration, or broken (denuded) skin from moisture, urinary or fecal incontinence
- Irritated, unbroken skin (perineal area)
- Fungal infection present in the perineal area
Exclusion Criteria:
- An existing pressure ulcer of any stage where the product will be applied
- Subjects not expected to survive the two week trial
- Subjects under age 18
- Subjects unable to provide informed consent (or whose designated power of attorney is unable to provide)
- Subjects with known sensitivity to any product preservative or other ingredient.
Sites / Locations
- Villa Maria Care Center
- Deer Meadows Retirement Community
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
treatment with OTC drug products
Arm Description
Body Wash & Shampoo applied directly to the skin or cloth; soiled area gently wiped clean. No rinsing necessary. Moisture Barrier Cream: Once area cleansed and dried thoroughly, a thin coat is gently applied to the area of the skin exposed to moisture twice daily for two weeks or as directed by doctor. 2-in-1 Cleanser: applied directly to the skin or a cloth and skin gently wiped clean. No rinsing necessary. Antifungal Cream: Once reddened area cleansed and dried thoroughly a thin layer is applied over the affected area twice daily for two weeks or as directed by doctor.
Outcomes
Primary Outcome Measures
skin condition following treatment
Results of skin assessment will be documented using the IAD (Incontinence-Associated Dermatitis) Skin Condition Assessment Tool. Individual subscores will be added together to provide a ten-point scale for measurement of skin condition
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01724229
Brief Title
Clinical Case Series Evaluating Skin Wellness System
Official Title
An Open-Label Clinical Case Series to Demonstrate Efficacy of the Kendall Skin Wellness System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GM Associates
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this evaluation is to observe the performance of two (2) different skin care treatment protocols on the skin:
#1 Kendall™ Body Wash & Shampoo in combination with the Moisture Barrier Cream; or #2 Kendall™ 2-in-1 Cleanser in combination with the Anti-fungal Cream.
The scientific evidence supports using these types of skin care products to keep the skin healthy in the presence of moisture, urine, stool, or fungal infection. The cleansers are preferred over soap and water and can be applied on all areas of the skin. The Moisture Barrier Cream is formulated especially for skin exposed to moisture, urine, or stool. The Antifungal Cream is utilized for fungal infections associated with athlete's foot, jock itch, and ring worm to relieve itching, soreness, and irritation.
Detailed Description
The Kendall™ Body Wash & Shampoo is a no-rinse cleanser that gently removed dirt, urine, and stool while maintaining the natural pH of the skin (although it contains a shampoo component); it can be applied on all areas of the skin. Kendall™ Moisture Barrier Cream performs as a barrier to moisture and irritants when the natural barrier ability of the skin has been compromised.
Kendall™ 2-in-1 Cleanser is a no-rinse cleanser that gently removes dirt, urine, and stool and protects the skin from damage. Kendall™ Antifungal Cream is used on fungal infections to relieve itching and discomfort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moisture-associated Dermatitis, Fungal Infection in Perineal Area
Keywords
Incontinence-associated dermatitis, Skin care regimen for moisture-associated conditions, Perineal skin care, Fungal infection in perineal area
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment with OTC drug products
Arm Type
Other
Arm Description
Body Wash & Shampoo applied directly to the skin or cloth; soiled area gently wiped clean. No rinsing necessary.
Moisture Barrier Cream: Once area cleansed and dried thoroughly, a thin coat is gently applied to the area of the skin exposed to moisture twice daily for two weeks or as directed by doctor.
2-in-1 Cleanser: applied directly to the skin or a cloth and skin gently wiped clean. No rinsing necessary.
Antifungal Cream: Once reddened area cleansed and dried thoroughly a thin layer is applied over the affected area twice daily for two weeks or as directed by doctor.
Intervention Type
Drug
Intervention Name(s)
Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream
Primary Outcome Measure Information:
Title
skin condition following treatment
Description
Results of skin assessment will be documented using the IAD (Incontinence-Associated Dermatitis) Skin Condition Assessment Tool. Individual subscores will be added together to provide a ten-point scale for measurement of skin condition
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects with any of the following indications:
Erythema, maceration, or broken (denuded) skin from moisture, urinary or fecal incontinence
Irritated, unbroken skin (perineal area)
Fungal infection present in the perineal area
Exclusion Criteria:
An existing pressure ulcer of any stage where the product will be applied
Subjects not expected to survive the two week trial
Subjects under age 18
Subjects unable to provide informed consent (or whose designated power of attorney is unable to provide)
Subjects with known sensitivity to any product preservative or other ingredient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenda J Motta, BSN, MPH, ET
Organizational Affiliation
GM Associates Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Villa Maria Care Center
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Deer Meadows Retirement Community
City
Southampton
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22193141
Citation
Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, Selekof J, Doughty D, Kurz P. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):61-74. doi: 10.1097/WON.0b013e31823fe246.
Results Reference
background
Citation
Kennedy K, Leighton B, Lutz J. Cost-effectiveness evaluation of a new alchool-free, film-forming incontinence skin protectant. proceedings from the European Conference on Advances in Wound Management, Amsterdam, Oct. 1996
Results Reference
background
Learn more about this trial
Clinical Case Series Evaluating Skin Wellness System
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