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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this study is to determine the effects of NanoDOX Hydrogel versus Placebo Hydrogel on Dehisced Surgical Wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoDOX Hydrogel | Experimental |
| |
| Placebo Hydrogel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoDOX 1% doxycycline monohydrate Hydrogel | Drug | 1% doxycycline monohydrate hydrogel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of 100% wound closure during the 8-week study | subjects will be followed during their participation in the study for an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint | determined by wound score, area of the wound, and the assessment of wound effluent cytokine, chemokine, protease, and patient reported pain and quality of life questionnaires | subjects will be followed during their participatoni in the study for an average of 8 weeks |
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Inclusion Criteria:
Be 18 years of age or older
Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline, and:
Agree to use a double-barrier method of contraception during their participation in this study;
Have a full-thickness dehisced surgical wound that is between 1.2cm2 and 4 cm2 at initial screening
Be able to apply study drug to their wound, or have a reliable and capable caregiver do it
Subjects will have adequate blood flow to the wound as defined by transcutaneous oxygen tension (TcpO2) of >30mmHg recorded over intact epidermis at the dehisced surgical wound margin
Non-infected (Quantitative bacterial count of < 1.0 x 105 cfu)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
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| placebo hydrogel |
| Drug |
placebo hydrogel |
|