Erythema, Lesion Skin, Maceration, Skin Folds
Conditions
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.
Interventions
DEVICEDriGo 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.
Sponsors
Medline Industries
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythema | day 0, day 1, day 3 | 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. |
| Maceration | day 0, day 1, day 3. | 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. |
| Denudation | day 0, day 1, and day 3. | 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. |
| Satellite Lesions | 5 days | 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. |
| Odor | Day 0, day 1, day 3 and day 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control. | Day 0, day 1, day 3, and day 5 | 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. |
| Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm | End of the study on day 5 | 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. |
| Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change | day 0, day 1, day 3 | 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. |
| Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3 | day 0, day 1, day3 | 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 |
| Did the Product Reduce Your Discomfort Assessed at Discharge Day 5 | 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. |
| The Product Dressing Was Comfortable to Wear | Day 5 | 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. |
Countries
United States
Participant flow
Recruitment details
Enrollment was based on the total number of target areas for review. A minimum of 80 target areas were required to complete the enrollment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| Total | 46 |
Baseline characteristics
| Characteristic | DriGo SPT | — |
|---|---|---|
| Age, Continuous | 67.61 years STANDARD_DEVIATION 10.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 46 Participants | — |
| Sex: Female, Male Female | 37 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
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.
Time frame: day 0, day 1, and day 3.
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DriGo SPT | Denudation | Day 0 | 0.88 units on a scale | Standard Deviation 0.84 |
| DriGo SPT | Denudation | Day 1 | 0.60 units on a scale | Standard Deviation 0.66 |
| DriGo SPT | Denudation | Day 3 | 0.20 units on a scale | Standard Deviation 0.44 |
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.
Time frame: day 0, day 1, day 3
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DriGo SPT | Erythema | Day 0 | 2.15 units on a scale | Standard Deviation 0.82 |
| DriGo SPT | Erythema | Day 1 | 2.15 units on a scale | Standard Deviation 0.72 |
| DriGo SPT | Erythema | Day 3 | .78 units on a scale | Standard Deviation 0.81 |
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.
Time frame: day 0, day 1, day 3.
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DriGo SPT | Maceration | Day 0 | 0.73 units on a scale | Standard Deviation 0.82 |
| DriGo SPT | Maceration | Day 1 | 0.49 units on a scale | Standard Deviation 0.65 |
| DriGo SPT | Maceration | Day 3 | 0.45 units on a scale | Standard Deviation 0.64 |
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.
Time frame: Day 0, day 1, day 3 and day 5
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DriGo SPT | Odor | Odor Present day 0 | 23 participants |
| DriGo SPT | Odor | Odor present day 1 | 11 participants |
| DriGo SPT | Odor | Odor present day 3 | 12 participants |
| DriGo SPT | Odor | odor present day 5 | 10 participants |
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.
Time frame: 5 days
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DriGo SPT | Satellite Lesions | day 1 | 5 participants |
| DriGo SPT | Satellite Lesions | day 3 | 3 participants |
| DriGo SPT | Satellite Lesions | day 5 | 0 participants |
| DriGo SPT | Satellite Lesions | day 0 | 5 participants |
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.
Time frame: day 0, day 1, day 3
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DriGo SPT | Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change | Discomfort (Pain, Itching, or Burning) experienced before the dressing change. Day 0 | 17 score on a scale - VAS score 0-100 mm | Standard Deviation 34 |
| DriGo SPT | Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change | Discomfort (Pain, Itching, or Burning) experienced before the dressing change. Day 1 | 0 score on a scale - VAS score 0-100 mm | Standard Deviation 23 |
| DriGo SPT | Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change | Discomfort (Pain, Itching, or Burning) experienced before the dressing change. Day 3 | 0 score on a scale - VAS score 0-100 mm | Standard Deviation 22 |
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.
Time frame: Day 5
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DriGo SPT | Did the Product Reduce Your Discomfort Assessed at Discharge Day 5 | 98 score on a scale VAS score 0-100 mm | Standard Deviation 23 |
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
Time frame: day 0, day 1, day3
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DriGo SPT | Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3 | discomfort (Pain, Itching, or Burning) experienced after the dressing change Day 1 | 10.6 score on a scale - VAS score 0-100 mm | Standard Deviation 18 |
| DriGo SPT | Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3 | discomfort (Pain, Itching, or Burning) experienced after the dressing change Day 3 | 8.1 score on a scale - VAS score 0-100 mm | Standard Deviation 17 |
| DriGo SPT | Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3 | discomfort (Pain, Itching, or Burning) experienced after the dressing change Day 0 | 24.7 score on a scale - VAS score 0-100 mm | Standard Deviation 32 |
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.
Time frame: End of the study on day 5
Population: HCP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DriGo SPT | Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm | 93 score on a scale - VAS score 0-100 mm | Standard Deviation 12 |
| Summary Statistics of HCP | Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm | 89 score on a scale - VAS score 0-100 mm | Standard Deviation 20 |
| Summary Statistics of HCP Was Easy to Apply | Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm | 97 score on a scale - VAS score 0-100 mm | Standard Deviation 6.8 |
| Summary Statistics of: I Would Recommend DriGo to Others. | Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm | 94 score on a scale - VAS score 0-100 mm | Standard Deviation 18 |
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.
Time frame: Day 0, day 1, day 3, and day 5
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DriGo SPT | Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control. | Moisture small/moderate day 1 | 16 participants |
| DriGo SPT | Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control. | Moisture absent/scant day 3 | 15 participants |
| DriGo SPT | Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control. | Moisture small/moderate day 3 | 7 participants |
| DriGo SPT | Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control. | Moisture absent/scant day 0 | 15 participants |
| DriGo SPT | Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control. | Moisture small/moderate day 0 | 20 participants |
| DriGo SPT | Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control. | Moisture absent/scant day 1 | 13 participants |
| DriGo SPT | Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control. | Moisture absent/scant day 5 | 10 participants |
| DriGo SPT | Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control. | Moisture small/moderate day 5 | 4 participants |
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.
Time frame: Day 5
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DriGo SPT | The Product Dressing Was Comfortable to Wear | 96 score on a scale - VAS score 0-100 mm | Standard Deviation 8.9 |