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Study will be redesigned.
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This will be an observational study evaluating subject's perception of pain to dressing changes during removal and application of a surfactant gel. Wound healing will also be monitored. Anxiety before dressing change will be measured using a burn specific pain anxiety scale. Study intervention will include cleansing the wound per the facility's standard of care, followed by applying the investigational product on the wound. This will be followed by placing an appropriate secondary dressing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surfactant Gel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surfactant Gel | Device | This device is helps in the creation of an optimal moist wound healing environment that aids in protecting healthy tissues and provides an environment conductive to autolytic debridement. The device is 100% water-soluble, biocompatible, and non-ionic. The dressing is a surfactant based gel. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported evaluation of subject pain perception during dressing changes using a numerical pain scale. | The numerical pain scale will be from 0 to 10 with 0 being no pain at all and 10 being the worst pain ever possible. This is the numeric rating scale. | Baseline to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure percent change in epithelium as recorded by the clinician. | Baseline to Day 30 | |
| Measure percent change in necrotic tissue in the wound bed | Baseline to Day 30 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States | ||
| Baton Rouge General Medical Center |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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This device is helps in the creation of an optimal moist wound healing environment that aids in protecting healthy tissues and provides an environment conductive to autolytic debridement. The device is 100% water-soluble, biocompatible, and non-ionic. The dressing is a surfactant based gel.
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|
| Measure change in wound size |
| Baseline to Day 30 |
| Measure anxiety using a burn specific anxiety scale | A burn-specific pain anxiety scale will be used to measure level of anxiety. Items will be scored on a 100mm visual analog line with two reference points, 0 and 100. These reference points will also be identified by expressions "not at all" and "the worst imaginable way". Subjects will be requested to scale the strength of their feelings relative to two reference points. | Baseline to Day 30 |
| Baton Rouge |
| Louisiana |
| 70809 |
| United States |