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NCT05742347 · ClinicalTrials.gov registry record · NA

Skin Protectant Textile Efficacy Study for Managing Skin Fold Conditions

A NA study, sponsored by Medline Industries.

Terminated
Registry status
NA
Development phase
47
Enrollment target

NCT05742347: Clinical Trial NA study, sponsored by Medline Industries.

NCT05742347 is a NA study that was terminated before completion, run by Medline Industries. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05742347, a NA study, was terminated before completion, sponsored by Medline Industries.

TERMINATED
Registry status
NA
Development phase
47 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DEVICE DriGo Skin Protectant Textile

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2022-07-01
Est. Completion 2024-09-26
Phase NA
Medline Industries

24 total trials

Why NCT05742347 stopped before completion

NCT05742347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which DriGo Skin Protectant Textile is the first listed.

NCT05742347 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05742347 about?

NCT05742347 is a clinical study titled "Skin Protectant Textile Efficacy Study for Managing Skin Fold Conditions". 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 pati...

What is the current status of trial NCT05742347?

This trial is currently terminated. It is a NA study. The enrollment target is 47 participants. The study started on 2022-07-01. Estimated completion is 2024-09-26.

What interventions are being tested in trial NCT05742347?

The interventions under investigation include: DriGo Skin Protectant Textile (DEVICE).

Who is sponsoring clinical trial NCT05742347?

This trial is sponsored by Medline Industries, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05742347's enrollment target sits among peer trials

47 1400th of 2000 higher than 599 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05742347, the US trial registry maintained by the National Library of Medicine. NCT05742347 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.