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The current study will evaluate the duration of wear and durability of two commercially available SBPs: Medline Marathon® XL (extra long) No Sting Cyanoacrylate Skin Protectant (henceforth referred to as "Marathon®") and 3M™ Cavilon™ Advanced Skin Protectant (henceforth referred to as "Cavilon™").
Completion of informed consent and participant screening will be followed by a washout period of minimum 18 hours (wherein participants will be asked to avoid application of cleansers, lotions, or perfumes to both forearms and inner elbows) prior to the first visit (Visit 1) of the study. During Visit 1, study personnel will confirm that the washout period has been successfully completed. Participants will wash their forearms and inner elbows with a standardized soap and dry them using paper towels for each arm. After the participants' forearms and inner elbows have fully dried, study personnel will use a Corneometer® (which measures skin hydration) to record baseline measurements of the skin within 2-inch x 2-inch squares (starting about two inches above the wrist) marked with a non-toxic marker on the volar forearms and inner elbows of the participants. Thereafter, participants will be randomized to the two SBPs, Marathon® or Cavilon™ (designated SBP). The designated SBP will be applied to the volar forearm and inner elbow "test areas" on the participant's dominant arm (as determined by the participant). The other SBP will be applied to the volar forearm and inner elbow "test areas" on the participant's non-dominant arm. A distinct area of each volar forearm will be used as an "untreated control area". Corneometer® measurements will be taken again on the same day after the SBPs have been left to dry for at least one minute or have fully dried. Thereafter, subsequent measurements will be taken daily over a seven-day period with a two-day break over the weekend. Each participant will commence the study on Monday or Tuesday. This will permit daily readings for the first 72 hours, which is the more important window to evaluate SBP wear time. There will be a two-day break in measurements over the weekend, after which Corneometer® measurements will be taken either on Monday, or Monday and Tuesday, depending on the participants' start date. Participants will be allowed to bathe their arms using a standardized soap provided by the study personnel but will be asked to minimize scrubbing and any other abrasion of the volar forearms and inner elbows. In addition, participants will be instructed not to engage in activities, for eg, sports (eg, tennis) or holding a baby that may cause significant abrasion on one arm and not the other. On the last visit of the study (Visit 6), study personnel will take the last set of Corneometer® measurements. In addition, participants will also complete surveys regarding their experience with the SBPs on specific days during study participation.
The Corneometer® measurements will help determine the presence of the SBPs and their deterioration over time. Skin treated with the SBPs will typically have lower readings than untreated skin. As the SBPs break down, the corresponding readings are expected to rise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| receives both product | Other | all participants receive both products under evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant | Device | All participants will receive both device interventions listed above. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration | To evaluate the duration of wear of Marathon® and Cavilon™ using the Corneometer® CM (capacitance method) 825 taking measurements of the skin (in Arbitrary Units) with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points. | 7 Days - Baseline + 6 visits = 7 |
| Durability | To evaluate the durability of Marathon® and Cavilon™ using the Corneometer® CM 825 taking measurements of the skin (in Arbitrary Units) in the inner elbow location with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points. | 7 Days - Baseline + 6 visits = 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Feedback 2 | To collect information on the participant experience with the two SBPs (Skin Barrier Protectants) using survey results (5 point scale from very comfortable to very uncomfortable). This question was on assessed at visit one. | 1 day |
| Participant Feedback |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Miller | Medline Industries, LP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medline Industries, LP | Northfield | Illinois | 60093 | United States |
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All participants received both the Medline and Cavilon products. Analysis was performed per product not per arm randomization. The dominant arm of participants was randomized to receive one intervention (i.e., " Marathon® or Cavilon™ ), and the non-dominant arm received the other intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | all participants receive both products under evaluation. Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant: All participants will receive both device interventions listed above. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | all participants receive both products under evaluation. Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant: All participants will receive both device interventions listed above. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Duration | To evaluate the duration of wear of Marathon® and Cavilon™ using the Corneometer® CM (capacitance method) 825 taking measurements of the skin (in Arbitrary Units) with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points. | Low arbitrary units correlate with less moisture (better skin protectant). As skin protectant wears off, arbitrary units will increase over time indicating duration of wear of skin protectant. | Posted | Mean | Standard Deviation | arbitrary units | 7 Days - Baseline + 6 visits = 7 |
|
2 months
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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 | Marathon® XL No Sting Cyanoacrylate Skin Protectant | all participants receive both products under evaluation, however, clinical trials.gov requested adverse events be reported as separate arms per intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Miller | Medline Industries, LP | 630-418-6891 | jamiller@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 | Aug 8, 2022 | Feb 1, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2022 | Jun 27, 2023 | ICF_001.pdf |
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To collect information on the participant experience with the two SBPs using survey results (yes/no questions). This measurement collected on visit thee and visit six. |
| 2 Days |
| Participant Feedback - Product Preference | Collect participant feedback on which arm is it easier to determine the skin barrier protectant is present? | 7 Days - Baseline + 6 visits = 7 |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Fitzpatrick Skin Assessment Scale | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Durability | To evaluate the durability of Marathon® and Cavilon™ using the Corneometer® CM 825 taking measurements of the skin (in Arbitrary Units) in the inner elbow location with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points. | Posted | Mean | Standard Deviation | percent change | 7 Days - Baseline + 6 visits = 7 |
|
|
|
| Secondary | Participant Feedback 2 | To collect information on the participant experience with the two SBPs (Skin Barrier Protectants) using survey results (5 point scale from very comfortable to very uncomfortable). This question was on assessed at visit one. | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Participant Feedback | To collect information on the participant experience with the two SBPs using survey results (yes/no questions). This measurement collected on visit thee and visit six. | Posted | Count of Participants | Participants | 2 Days |
|
|
|
| Secondary | Participant Feedback - Product Preference | Collect participant feedback on which arm is it easier to determine the skin barrier protectant is present? | Posted | Count of Participants | Participants | 7 Days - Baseline + 6 visits = 7 |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 3M™ Cavilon™ Advanced Skin Protectant | all participants receive both products under evaluation, however, clinical trials.gov requested adverse events be reported as separate arms per intervention. | 0 | 42 | 0 | 42 | 0 | 42 |
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| Title | Measurements |
|---|---|
|
| Cavilon Visit 1 |
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| Marathon Visit 2 |
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| Cavilon Visit 2 |
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| Marathon Visit 3 |
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| Cavilon Visit 3 |
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| Marathon Visit 4 |
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| Cavilon Visit 4 |
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| Marathon Visit 5 |
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| Cavilon Visit 5 |
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| Marathon Visit 6 |
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| Cavilon Visit 6 |
|
| Uncomfortable |
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| Very Uncomfortable |
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| Cavilon Visit 1: Is the SBP comfortable on your arm |
|
| no |
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| Marathon Visit 3: Did the SBP accumulate dirt or debris? |
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| Cavilon Visit 3: Did the SBP accumulate dirt or debris? |
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| Marathon Visit 3: Did the SBP adhere to clothing or material? |
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| Cavilon Visit 3: Did the SBP adhere to clothing or material? |
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| Marathon Visit 6: Do you see the SBP on your skin? |
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| Cavilon Visit 6: Do you see the SBP on your skin? |
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| Marathon Visit 6: Did the SBP accumulate dirt or debris? |
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| Cavilon Visit 6: Did the SBP accumulate dirt or debris? |
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| Marathon Visit 6: Did the SBP adhere to clothing or material? |
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| Cavilon Visit 6: Did the SBP adhere to clothing or material? |
|