Skin Protectant Textile Efficacy Study for Managing Skin Fold Conditions

Study Overview
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Brief Summary
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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. 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.

Official Title
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Efficacy of a Skin Protectant Textile for the Management of Skin Fold Conditions

Conditions
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Erythema, Maceration, Lesion Skin, Skin Folds

Intervention / Treatment
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* Device: DriGo Skin Protectant Textile


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DriGo SPT<br>All participants will have the DriGo skin protectant textile applied to their skin fold condition. | Device: DriGo Skin Protectant Textile<br>* All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of SPT to improve skin fold conditions as it pertains to skin fold healing | Improvement in skin fold conditions such as erythema, maceration, denudation, satellite lesions, odor, pain, itching, and burning over five days of treatment. Improvement assessed using 1. Likert scales developed for erythema, maceration, denudation, and satellite lesions. Scoring of the target area(s) done by a third-party clinician using the Likert scale(s) and photographs taken by the PI or qualified designee on Day 0, and on Days 1, 3, and 5, during SPT changes. | 5 days | 
| To evaluate the efficacy of SPT to improve skin fold conditions as it pertains to participant assessment | Improvement in skin fold conditions such as erythema, maceration, denudation, satellite lesions, odor, pain, itching, and burning over five days of treatment. Improvement assessed using assessment of odor in the target area(s) on Day 0, and on Days 1, 3, and 5, during SPT changes, using a Likert scale. Participant assessment of discomfort (pain, itching, and burning) assessment using a VAS on Day 0, and on Days 1, 3, and 5, during SPT changes. Participants will also be asked to identify the most prominent type of discomfort in the skin fold: pain, itching, or burning. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To gather PI or qualified designee's assessment of moisture control in the target areas | PI or qualified designee survey response for moisture in the target area(s) on Day 0, and on Days 1, 3, and 5, during SPT changes, using a Likert scale (5-scale likert ranging from absent to large). | 5 days | 
| To assess HCP feedback on the SPT | HCP survey responses on Day 5 regarding feedback about the SPT, using a VAS (0-100 scale; 0 being strongly disagree, 100 being strongly agree) | 5 days | 
| To assess the overall participant experience with the SPT | Participant responses on Day 5 regarding their experience with the SPT, using a VAS (0-100 scale; 0 being no discomfort, 100 being intense discomfort) | 5 days |