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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Jacksonville Center For Clinical Research | OTHER |
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This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients diagnosed with a chronic wound. The primary objective is to assess changes in healing rate, by measuring differences in wound area when treating chronic wounds with the Next Science Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At the end of the study period, patients may continue receiving their assigned study treatment provided they have signed the "Continuation of Treatment Informed Consent" and the rational for continuation is documented by the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple Antibiotic Ointment Neosporin | Active Comparator | Daily direct application to the wound, covered with conventional dressing. Dressing should be changed daily or as directed by the health care provider. |
|
| Next Science Wound Gel | Experimental | Daily direct application to the wound, covered with a conventional non-alginate dressing. Dressing should be changed daily or as directed by the health care provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Next Science Wound Gel | Device |
| ||
| Triple Antibiotic Ointment Neosporin |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Size Reduction | 2, 4, 8 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Closure | 2, 4, 8 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of bacterial species types and amounts | 0 and 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States | ||
| Jacksonville Center for Clinical Research - RCCR location |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 13, 2019 | |
| Reset | Apr 5, 2019 | |
| Release | May 14, 2019 | |
| Reset | Jun 4, 2019 | |
| Release | Jul 22, 2019 | |
| Reset | Aug 13, 2019 | |
| Release | Nov 5, 2023 | |
| Reset | Nov 27, 2023 | |
| Release | Dec 6, 2023 | |
| Reset | Dec 26, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 13, 2019 | Apr 5, 2019 | |||
| May 14, 2019 |
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| Drug |
Subjects randomized to Neosporin will be required to complete 1 month of treatment comprising a screening/baseline, 2-week and 1-month visits. After 1 month the following may occur based on wound progression and/or the investigator's clinical judgment:
|
|
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Jun 4, 2019 |
| Jul 22, 2019 | Aug 13, 2019 |
| Nov 5, 2023 | Nov 27, 2023 |
| Dec 6, 2023 | Dec 26, 2023 |