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This is an open-label study. A total of approximately 60 subjects will be randomly assigned to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe or a heat patch (30 subjects) alone. The study will consist of 2 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temperature | Experimental | Evaluate the temperature profile of the air activated 3-cell patch during 8 hours of wear |
|
| Adhesion | Experimental | Evaluate the adhesion with and without the presence of a temperature probe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell) | Device |
| ||
| Temperature Probe |
| Measure | Description | Time Frame |
|---|---|---|
| Patch Temperature | The temperature of the patch will be monitored by the use of a probe placed under the patch and recorded for the duration of the study. | 8 hours |
| Patch Adhesion | Patch adhesion will be recorded for the duration of the study. | 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Bonagua, MD | Chattem, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilkins Research | Chattanooga | Tennessee | 37421 | United States |
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| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Other |
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