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The site sent a formal notification letter of their decision to terminate the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DriGo SPT | Experimental | All participants will have the DriGo skin protectant textile applied to their skin fold condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bryan Medical Center | Lincoln | Nebraska | 68506 | United States |
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Enrollment was based on the total number of target areas for review. A minimum of 80 target areas were required to complete the enrollment.
| ID | Title | Description |
|---|---|---|
| FG000 | DriGo SPT | All participants will have the DriGo skin protectant textile applied to their skin fold condition. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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A total of 46 participants contributing 82 target areas completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | DriGo SPT | All participants will have the DriGo skin protectant textile applied to their skin fold condition. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Each participant was asked by study staff to report their age in years and this was recorded on the case report form at the time of screening. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor | Posted | Mean | Standard Deviation | units on a scale | day 0, day 1, day 3 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants will have the DriGo skin protectant textile applied to their skin fold condition. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie J. Finley | Medline Industries, LP | (800) 33-5463 | jjfinely@medline.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2023 | Jan 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004890 | Erythema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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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.
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| Day 0, day 1, day 3 and day 5 |
| 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. | 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 | 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. | 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. | 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. | End of the study on day 5 |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Each participant was asked by study staff to report which sex they identify with and this information was recorded on the case report form at the time of screening. | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | All participants were local to Bryan Medical Center in Lincoln Nebraska, located in the Midwest United States. | Count of Participants | Participants | No |
|
|
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| Primary | 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. | Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor | Posted | Mean | Standard Deviation | units on a scale | day 0, day 1, day 3. |
|
|
|
| Primary | 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. | Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor | Posted | Mean | Standard Deviation | units on a scale | day 0, day 1, and day 3. |
|
|
|
| Primary | 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. | Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor | Posted | Number | participants | 5 days |
|
|
|
| Primary | 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. | Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor | Posted | Number | participants | Day 0, day 1, day 3 and day 5 |
|
|
|
| Secondary | 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. | Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor | Posted | Number | participants | Day 0, day 1, day 3, and day 5 |
|
|
|
| Secondary | 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. | Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor | Posted | Mean | Standard Deviation | score on a scale - VAS score 0-100 mm | day 0, day 1, day 3 |
|
|
|
| Secondary | 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 | Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor | Posted | Mean | Standard Deviation | score on a scale - VAS score 0-100 mm | day 0, day 1, day3 |
|
|
|
| Secondary | 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. | ndividuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor | Posted | Mean | Standard Deviation | score on a scale VAS score 0-100 mm | Day 5 |
|
|
|
| Secondary | 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. | Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor | Posted | Mean | Standard Deviation | score on a scale - VAS score 0-100 mm | Day 5 |
|
|
|
| Secondary | 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. | HCP | Posted | Mean | Standard Deviation | score on a scale - VAS score 0-100 mm | End of the study on day 5 |
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| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|
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| day 5 |
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| Title | Measurements |
|---|---|
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| odor present day 5 |
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| Title | Measurements |
|---|---|
|
| Moisture small/moderate day 1 |
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| Moisture absent/scant day 3 |
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| Moisture small/moderate day 3 |
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| Moisture absent/scant day 5 |
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| Moisture small/moderate day 5 |
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