Treatment of Incontinence Associated Dermatitis - Automated
| Status: | Recruiting |
|---|---|
| Conditions: | Psoriasis, Dermatology, Urology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/2/2018 |
| Start Date: | April 1, 2017 |
| End Date: | September 2019 |
| Contact: | Jacqueline Silvia |
| Email: | jsilvia@schwabcare.com |
| Phone: | +1 (855) 239-2106 |
Incontinence and the skin irritation (dermatitis) associated with it are common problems.
Treatment of dermatitis is effective, but requires effective cleaning and application of a
barrier substance to prevent further contact between urine or feces and the skin. Water based
cleansing with the addition of a pH balanced cleanser is more effective than standard
abrasive cleansing with paper or a cloth, and is better tolerated by those with skin
irritation. Zinc oxide based barriers effectively promote healing and prevent further skin
damage. Spray forms are less cumbersome and generally preferred, but are difficult to for the
patient to apply independently given the challenge of accessing the perineum.
40 patients, recruited from 3 specialty pelvic floor centers and 1 assisted living center
will be provided a device that cleans, dries, and applies zinc oxide barrier spray with each
use of the toilet. Dermatitis will be evaluated at the beginning of the study, and at weeks
1, 2 and 6 by medical staff using a standard scale (The Kennedy Scale).Quality of life will
be measured using a visual analog scale derived from the quality of life in incontinence
scale.
The investigators hypothesize that the device will 1) effectively treat incontinence
associated dermatitis, 2) prevent recurrence, and 3) be preferred over standard treatment.
Treatment of dermatitis is effective, but requires effective cleaning and application of a
barrier substance to prevent further contact between urine or feces and the skin. Water based
cleansing with the addition of a pH balanced cleanser is more effective than standard
abrasive cleansing with paper or a cloth, and is better tolerated by those with skin
irritation. Zinc oxide based barriers effectively promote healing and prevent further skin
damage. Spray forms are less cumbersome and generally preferred, but are difficult to for the
patient to apply independently given the challenge of accessing the perineum.
40 patients, recruited from 3 specialty pelvic floor centers and 1 assisted living center
will be provided a device that cleans, dries, and applies zinc oxide barrier spray with each
use of the toilet. Dermatitis will be evaluated at the beginning of the study, and at weeks
1, 2 and 6 by medical staff using a standard scale (The Kennedy Scale).Quality of life will
be measured using a visual analog scale derived from the quality of life in incontinence
scale.
The investigators hypothesize that the device will 1) effectively treat incontinence
associated dermatitis, 2) prevent recurrence, and 3) be preferred over standard treatment.
Incontinence and incontinence associated dermatitis (IAD) are common problems. A recent CDC
study noted that up to 50% of noninstitutionalized patients aged 65 and older experienced
episodes of incontinence at least monthly, and that 40% of those with incontinence develop
secondary IAD The treatment of IAD is focused on effective cleaning and prevention of further
exposure to irritant liquids and solids through barrier creams. Enzymatic washes have proven
efficacy over soap and water, and zinc oxide is the standard of care for barrier function.
Combined, effective cleansing and barrier use treats IAD in as little as 6 days, and
effectively prevents recurrent skin damage. In one study, an effective preventive regimen of
regularly applied skin therapy reduced the incidence of IAD in an at risk population from 25%
to 5%. The combination of enzymatic skin cleanser and barrier protection is the standard of
care for maintenance of skin integrity in patients with chronic urinary and fecal
incontinence.
Adherence to prescribed regimens is a major barrier to regular use of substances applied to
the perineum. Difficulty in accessing the perineum make adherence challenging to those with
both full and limited mobility, often requiring assistance from a caregiver. The associated
loss of independence and dignity are major detriments to quality of life. Novel formulations
of zinc oxide, using aerosol based spray application, facilitate use and improve patient
acceptance. In a 2014 nursing home based industry study, spray based zinc oxide was preferred
by 80% of patients and caregivers, and improved treatment and prevention of IAD in 70% of the
study participants.
Adequate cleansing and drying prior to the application of barrier products is key to
effective prevention of skin breakdown. Water-based cleaning of the perineum after toileting
has been demonstrated to improve hygiene over standard mechanical, paper-based cleansing,
especially in those with limited mobility or incontinence. Evidence further demonstrates that
the addition of pH balanced cleansers, applied without mechanical abrasion from cloths or
wipes, advances hygiene and minimizes risk of secondary infection.
Study Aims
The aims of this study are to evaluate the efficacy of an automated delivery system for
cleansing the perineum, and applying zinc oxide barrier spray to effectively treat and
prevent incontinence associated dermatitis in a population with active or recurrent IAD.
Secondary aims will be to assess preference for the automated delivery system over standard
wash and manually applied barrier sprays.
study noted that up to 50% of noninstitutionalized patients aged 65 and older experienced
episodes of incontinence at least monthly, and that 40% of those with incontinence develop
secondary IAD The treatment of IAD is focused on effective cleaning and prevention of further
exposure to irritant liquids and solids through barrier creams. Enzymatic washes have proven
efficacy over soap and water, and zinc oxide is the standard of care for barrier function.
Combined, effective cleansing and barrier use treats IAD in as little as 6 days, and
effectively prevents recurrent skin damage. In one study, an effective preventive regimen of
regularly applied skin therapy reduced the incidence of IAD in an at risk population from 25%
to 5%. The combination of enzymatic skin cleanser and barrier protection is the standard of
care for maintenance of skin integrity in patients with chronic urinary and fecal
incontinence.
Adherence to prescribed regimens is a major barrier to regular use of substances applied to
the perineum. Difficulty in accessing the perineum make adherence challenging to those with
both full and limited mobility, often requiring assistance from a caregiver. The associated
loss of independence and dignity are major detriments to quality of life. Novel formulations
of zinc oxide, using aerosol based spray application, facilitate use and improve patient
acceptance. In a 2014 nursing home based industry study, spray based zinc oxide was preferred
by 80% of patients and caregivers, and improved treatment and prevention of IAD in 70% of the
study participants.
Adequate cleansing and drying prior to the application of barrier products is key to
effective prevention of skin breakdown. Water-based cleaning of the perineum after toileting
has been demonstrated to improve hygiene over standard mechanical, paper-based cleansing,
especially in those with limited mobility or incontinence. Evidence further demonstrates that
the addition of pH balanced cleansers, applied without mechanical abrasion from cloths or
wipes, advances hygiene and minimizes risk of secondary infection.
Study Aims
The aims of this study are to evaluate the efficacy of an automated delivery system for
cleansing the perineum, and applying zinc oxide barrier spray to effectively treat and
prevent incontinence associated dermatitis in a population with active or recurrent IAD.
Secondary aims will be to assess preference for the automated delivery system over standard
wash and manually applied barrier sprays.
Inclusion Criteria:
- Ability to give informed consent.
- Active functional urinary or fecal incontinence
- Kennedy Scale Grade >2 with active incontinence associated dermatitis
- Willingness to have device installed in home/care center
Exclusion Criteria:
- Active perineal infection
- Prior pelvic radiation
- Perineal surgery within the prior 6 months
- Known allergy or sensitivity to applied agents
- Treatment for dermatitis within the prior 2 weeks.
- Pre-existing pressure ulcer stage 2-4
- Weight exceeding 300 pounds
- Known allergy or hypersensitivity to cleanser or zinc oxide barrier spray
- Home bathroom needs excessive upgrades, or needs ownership authorization
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