Clinical trial NCT01724229: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: GM Associates
Sponsor class: INDUSTRY
First posted: 2012-11-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: skin condition following treatment
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Villa Maria Care Center
state: Arizona
city: Southampton
country: United States
facility: Deer Meadows Retirement Community
state: Pennsylvania
Study officials:
affiliation: GM Associates Inc.
name: Glenda J Motta, BSN, MPH, ET
role: STUDY_DIRECTOR
References:
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.
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