Efficacy of a Skin Protectant Textile for the Management of Skin Fold Conditions
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Medline Industries
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Erythema
Overview
Brief Summary
This study will evaluate the efficacy of the DriGo skin protectant textile (SPT) to manage erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor associated with skin folds (henceforth together referred to as "skin fold conditions"). Participants will be patients with skin fold conditions, which will be treated with the SPT. Healthcare providers will apply the SPT to the participants' target areas. A given participant can have up to two target areas enrolled in the study. An independent licensed clinician with experience in identifying and treating skin fold conditions, will use photographs of the skin folds and other skin-on-skin contact areas (henceforth referred to as "target area[s]") to assess the status of erythema, maceration, denudation, and satellite lesions in the target areas when the SPT is first applied (Day 0), and on Days 1, 3, and 5, during SPT changes. The Principal Investigator (PI) or qualified designee will take photographs of the target areas and assess moisture and odor in these areas. Participants will provide their impressions of pain, itching and burning in the target area(s) on the same days as the skin fold condition photography. In addition, the study will include feedback from the Health Care Providers (HCPs) about the SPT and overall experience of the participants with the SPT.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Individuals ≥ 18 years of age.
- •Individuals who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor.
- •Individuals whose treatment plan permits assessment of the skin fold condition(s) for up to six days.
Exclusion Criteria
- •Individuals whose target area(s) are being managed with topical treatments such as antibiotics, antifungals, ointments including skin protectants, anti-itch products, anoperineal dressings or absorbent pads (eg, ARD®).
- •Individuals with a known allergy or sensitivity to the ingredients in the SPT, such as the fabric or H2O2, as well as the tape that may be used to secure the SPT.
Outcomes
Primary Outcomes
Erythema
Time Frame: day 0, day 1, day 3
The efficacy of the SPT to improve skinfold condition of erythema over three days of treatment were assessed by third party clinicians using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation on the scale for each timepoint.
Maceration
Time Frame: day 0, day 1, day 3.
The efficacy of the SPT to improve skinfold conditions of maceration over three days of treatment were assessed by third party clinician using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation values from the scale for each timepoint measured.
Denudation
Time Frame: day 0, day 1, and day 3.
The efficacy of the SPT to improve skinfold conditions denudation were assessed over 3 days by a third party clinician using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation value on the scale for each timepoint measured.
Satellite Lesions
Time Frame: 5 days
The efficacy of the SPT to improve skinfold conditions of satellite lesions were assessed by a third party clinician as absent or present each day over 5 days. Results for present lesions detected presented below. Data is reported as the percentage of participants identified with any satellite lesions.
Odor
Time Frame: Day 0, day 1, day 3 and day 5
The efficacy of the SPT to improve skinfold conditions of odor over five days of treatment was assessed by a third party clinician as absent or present with values for present noted below. Data is presented as the percentage of participants identified with any odor at the target area for each timepoint measured.
Secondary Outcomes
- Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.(Day 0, day 1, day 3, and day 5)
- Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change(day 0, day 1, day 3)
- Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3(day 0, day 1, day3)
- Did the Product Reduce Your Discomfort Assessed at Discharge Day 5(Day 5)
- The Product Dressing Was Comfortable to Wear(Day 5)
- Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm(End of the study on day 5)