Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742347
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-09
First Post:
2023-02-10
Brief Title:
Skin Protectant Textile Efficacy Study for Managing Skin Fold Conditions
Sponsor:
Medline Industries
Organization:
Medline Industries
Study Overview
Official Title:
Efficacy of a Skin Protectant Textile for the Management of Skin Fold Conditions
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 areas 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 areas 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None