An interventional study of DriGo Skin Protectant Textile in Erythema, Maceration and Lesion Skin, sponsored by Medline Industries. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Medline Industries · Not applicable, Interventional, and Supportive care
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.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's enrollment of 47 is close to the median of 50 across 114 interventional studies indexed under Erythema.
Browse Erythema studies →Medline Industries is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
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Exclusion Criteria:
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0, day 1, day 3 and day 5
Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
survey responses for moisture in the target area(s) on Day 0, and on Days 1, 3, and 5, during SPT changes, third party clinicians assessed the moisture as either abscent/scant or small/moderate. All other patients were coded as not able to detect. Data is presented as the percentage of participants with abscent/scant moisture at each timepoint and the percentage of participants with small/moderate moisture at each timepoint.
Time frame: Day 0, day 1, day 3, and day 5
Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change
Assessing Patient reported outcomes before the dressing change - VAS score 0-100 mm with 0 being the least amount of pain and 100 being the most painful.
Time frame: day 0, day 1, day 3
Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3
Assessing patient reported outcomes of discomfort (Pain, Itching, or Burning) experienced after the dressing change Patient Reported Outcomes: VAS score 0-100 mm with 0 being the least painful and 100 being the most painful
Time frame: day 0, day 1, day3
Did the Product Reduce Your Discomfort Assessed at Discharge Day 5
Summary Statistics of: The dressing significantly reduced discomfort (Pain, Itching, and Burning) in the skin-on-skin contact area (target area) at Day 5 with 0 being not at all and 100 being absolutely yes it helped reduce my discomfort.
Time frame: Day 5
The Product Dressing Was Comfortable to Wear
Summary Statistics of: The dressing was comfortable to wear at at Day 5. VAS score 0-100 mm with 0 being not at all comfortable and 100 being the most comfortable.
Time frame: Day 5
Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm
Summary Statistics of HCP: Instructions for application of the skin protectant textile (SPT) were easy to understand. Health care practioniers (HCPs) answered a series of questions regarding the instructions for the product. Each question answered on a scale of 0-100 with 0 being negative/difficult/not likely to reccomend and 100 being positive/easy to use/likely to reccomend to others. Data is reported as the mean value for the question asked based on the scale value of 0-100. These questions were only asked of the HCP at the end of the study on day 5.
Time frame: End of the study on day 5
Enrollment was based on the total number of target areas for review. A minimum of 80 target areas were required to complete the enrollment.
| Milestone | DriGo SPT |
|---|---|
| Started | 47 |
| Completed | 46 |
| Not completed | 1 |
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.
| units on a scale | DriGo SPT |
|---|---|
| Day 0 | 2.15 ± .82 |
| Day 1 | 2.15 ± 0.72 |
| Day 3 | .78 ± .81 |
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.
| units on a scale | DriGo SPT |
|---|---|
| Day 0 | 0.73 ± 0.82 |
| Day 1 | 0.49 ± 0.65 |
| Day 3 | 0.45 ± 0.64 |
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.
| units on a scale | DriGo SPT |
|---|---|
| Day 0 | 0.88 ± 0.84 |
| Day 1 | 0.60 ± 0.66 |
| Day 3 | 0.20 ± 0.44 |
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.
| participants | DriGo SPT |
|---|---|
| day 0 | 5 |
| day 1 | 5 |
| day 3 | 3 |
| day 5 | 0 |
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.
| participants | DriGo SPT |
|---|---|
| Odor Present day 0 | 23 |
| Odor present day 1 | 11 |
| Odor present day 3 | 12 |
| odor present day 5 | 10 |
survey responses for moisture in the target area(s) on Day 0, and on Days 1, 3, and 5, during SPT changes, third party clinicians assessed the moisture as either abscent/scant or small/moderate. All other patients were coded as not able to detect. Data is presented as the percentage of participants with abscent/scant moisture at each timepoint and the percentage of participants with small/moderate moisture at each timepoint.
| participants | DriGo SPT |
|---|---|
| Moisture absent/scant day 0 | 15 |
| Moisture small/moderate day 0 | 20 |
| Moisture absent/scant day 1 | 13 |
| Moisture small/moderate day 1 | 16 |
| Moisture absent/scant day 3 | 15 |
| Moisture small/moderate day 3 | 7 |
| Moisture absent/scant day 5 | 10 |
| Moisture small/moderate day 5 | 4 |
Assessing Patient reported outcomes before the dressing change - VAS score 0-100 mm with 0 being the least amount of pain and 100 being the most painful.
| score on a scale - VAS score 0-100 mm | DriGo SPT |
|---|---|
| Discomfort (Pain, Itching, or Burning) experienced before the dressing change. Day 0 | 17 ± 34 |
| Discomfort (Pain, Itching, or Burning) experienced before the dressing change. Day 1 | 0 ± 23 |
| Discomfort (Pain, Itching, or Burning) experienced before the dressing change. Day 3 | 0 ± 22 |
Assessing patient reported outcomes of discomfort (Pain, Itching, or Burning) experienced after the dressing change Patient Reported Outcomes: VAS score 0-100 mm with 0 being the least painful and 100 being the most painful
| score on a scale - VAS score 0-100 mm | DriGo SPT |
|---|---|
| discomfort (Pain, Itching, or Burning) experienced after the dressing change Day 0 | 24.7 ± 32 |
| discomfort (Pain, Itching, or Burning) experienced after the dressing change Day 1 | 10.6 ± 18 |
| discomfort (Pain, Itching, or Burning) experienced after the dressing change Day 3 | 8.1 ± 17 |
Summary Statistics of: The dressing significantly reduced discomfort (Pain, Itching, and Burning) in the skin-on-skin contact area (target area) at Day 5 with 0 being not at all and 100 being absolutely yes it helped reduce my discomfort.
| score on a scale VAS score 0-100 mm | Summary Statistics |
|---|---|
| Did the Product Reduce Your Discomfort Assessed at Discharge Day 5 | 98 ± 23 |
Summary Statistics of: The dressing was comfortable to wear at at Day 5. VAS score 0-100 mm with 0 being not at all comfortable and 100 being the most comfortable.
| score on a scale - VAS score 0-100 mm | Summary Statistics |
|---|---|
| The Product Dressing Was Comfortable to Wear | 96 ± 8.9 |
Summary Statistics of HCP: Instructions for application of the skin protectant textile (SPT) were easy to understand. Health care practioniers (HCPs) answered a series of questions regarding the instructions for the product. Each question answered on a scale of 0-100 with 0 being negative/difficult/not likely to reccomend and 100 being positive/easy to use/likely to reccomend to others. Data is reported as the mean value for the question asked based on the scale value of 0-100. These questions were only asked of the HCP at the end of the study on day 5.
| score on a scale - VAS score 0-100 mm | HCP Reported Ease of Use: VAS Score 0-100 mm | Summary Statistics of HCP | Summary Statistics of HCP Was Easy to Apply | Summary Statistics of: I Would Recommend DriGo to Others. |
|---|---|---|---|---|
| Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm | 93 ± 12 | 89 ± 20 | 97 ± 6.8 | 94 ± 18 |
Collected over Patients were followed for adverse events or severe adverse events while they were hospitalized for up to 5 days or discharge, which ever occurred first.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
A total of 46 participants contributing 82 target areas completed the study.
| Age, Continuous(years) | DriGo SPT |
|---|---|
| Mean | 67.61 ± 10.90 |
| Sex: Female, Male(Participants) | DriGo SPT |
|---|---|
| Female | 37 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | DriGo SPT |
|---|
| Region of Enrollment(Participants) | DriGo SPT |
|---|---|
| United States | 46 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2022 to primary completion in Aug 2024, 25 months.
Results were first posted in May 2025, 9 months after primary completion.
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