NCT05742347

Skin Protectant Textile Efficacy Study for Managing Skin Fold Conditions

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Medline Industries · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Erythema
• Maceration
• Lesion Skin
• Skin Folds

Interventions

Type	Name	Description
DEVICE	DriGo Skin Protectant Textile	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.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-08-12
• Completion: 2024-09-26
• First posted: 2023-02-24
• Last updated: 2025-05-21
• Results posted: 2025-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study