Skin Protectant Textile Efficacy Study for Managing Skin Fold Conditions

NCT05742347 | Terminated Results FDA Device

• 1 other identifier: MED-2021-DIV80-006
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Erythema; Maceration; Lesion Skin; Skin Folds

Outcome Measures

Primary Outcomes (5)

• Erythema

  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.

  day 0, day 1, day 3

• Maceration

  The efficacy of the SPT to improve skinfold conditions of maceration over three days of treatment were assessed by third party clinician 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 values from the scale for each timepoint measured.

  day 0, day 1, day 3.

• Denudation

  The efficacy of the SPT to improve skinfold conditions denudation were assessed over 3 days by a third party clinician 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 value on the scale for each timepoint measured.

  day 0, day 1, and day 3.

• Satellite Lesions

  The efficacy of the SPT to improve skinfold conditions of satellite lesions were assessed by a third party clinician as absent or present each day over 5 days. Results for present lesions detected presented below. Data is reported as the percentage of participants identified with any satellite lesions.

  5 days

• Odor

  The efficacy of the SPT to improve skinfold conditions of odor over five days of treatment was assessed by a third party clinician as absent or present with values for present noted below. Data is presented as the percentage of participants identified with any odor at the target area for each timepoint measured.

  Day 0, day 1, day 3 and day 5

Secondary Outcomes (6)

• Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.

  Day 0, day 1, day 3, and day 5

• Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change

  day 0, day 1, day 3

• Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3

  day 0, day 1, day3

• Did the Product Reduce Your Discomfort Assessed at Discharge Day 5

  Day 5

• The Product Dressing Was Comfortable to Wear

  Day 5

Study Arms (1)

DriGo SPT

EXPERIMENTAL

All participants will have the DriGo skin protectant textile applied to their skin fold condition.

Device: DriGo Skin Protectant Textile

Interventions

DriGo Skin Protectant Textile DEVICE

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.

DriGo SPT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (1)

Bryan Medical Center

Lincoln, Nebraska, 68506, United States

Location

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Julie J. Finley
• Organization: Medline Industries, LP

jjfinely@medline.com

(800) 33-5463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 24, 2023
• Study Start: July 1, 2022
• Primary Completion: August 12, 2024
• Study Completion: September 26, 2024
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Locations

US (1)