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The aim of this study is to assess the role of skin sensors in obtaining reliable and accurate serial measurements of skin parameters in the context of cutaneous skin wound healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin sensor on surgery side | Experimental | Skin sensor will be placed on the side that had surgery. This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body. |
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| Skin sensor on non-surgery side | Active Comparator | Skin sensor will be placed on the contralateral side from surgery site.This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin sensor | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure Temperature at 3 Time Points | Baseline, 48 hours from baseline, and 2 weeks from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgery Side and Non-surgery Side | This is a split-body, parallel-designed study. All study participants had the skin sensor (the same intervention) placed near the site of their surgery wound, and also on a site without any surgery wound. Since this is split-body design with one intervention, participant flow will be limited to all study participants as one group to not double-count the number of participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgery Side and Non-surgery Side | All study participants had the skin sensor placed near the site of their surgery wound, and also on a site without any surgery wound. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Measure Temperature at 3 Time Points | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline, 48 hours from baseline, and 2 weeks from baseline |
|
30 days
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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 | Surgery Side and Non-surgery Side | The skin sensor intervention was placed on both a surgery site and a non-surgery site in the same participant. This reflects all participants that received the intervention. The Arms/Groups "Surgery Side" and "Non-surgery Side" are combined because they both received the same intervention (skin sensor). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Murad Alam, MD | Northwestern University | 312-695-4761 | m-alam@northwestern.edu |
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Participants had the skin sensor measure temperature both near a surgery site and also near a non-surgery site. There is one intervention (skin sensor) and the participants were assigned to both arms "surgery side" and "non-surgery side" in parallel.
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
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| Participants |
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| 0 |
| 4 |
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| 4 |
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| 4 |
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