Clinical trial NCT05742347: Skin Protectant Textile Efficacy Study for Managing Skin Fold Conditions
Official title: Efficacy of a Skin Protectant Textile for the Management of Skin Fold Conditions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Erythema
Maceration
Lesion Skin
Skin Folds
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A total of 46 participants were enrolled in the study -- many contributed more than one target area for a total of 82 total target areas for the study.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Erythema
timeFrame: day 0, day 1, day 3
measure: Maceration
timeFrame: day 0, day 1, day 3.
measure: Denudation
timeFrame: day 0, day 1, and day 3.
measure: Satellite Lesions
timeFrame: 5 days
measure: Odor
timeFrame: Day 0, day 1, day 3 and day 5
Secondary outcomes:
measure: Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
timeFrame: Day 0, day 1, day 3, and day 5
measure: Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change
timeFrame: day 0, day 1, day 3
measure: Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3
timeFrame: day 0, day 1, day3
measure: Did the Product Reduce Your Discomfort Assessed at Discharge Day 5
timeFrame: Day 5
measure: The Product Dressing Was Comfortable to Wear
timeFrame: Day 5
measure: Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm
timeFrame: End of the study on day 5
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Bryan Medical Center
state: Nebraska
Study officials:
References: