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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 effect of NanoDOXâ„¢ Hydrogel in conjunction with serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and soft tissue wounds when compared to a serial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoDOX Hydrogel plus VAC | Experimental | NanoDOXâ„¢ Hydrogel in conjunction with serial wound debridement and irrigation on open traumatic orthopedic and soft tissue wounds in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings. |
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| VAC Alone | Active Comparator | Serial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoDOX Hydrogel | Drug | NanoDOX Hydrogel will be applied three time weekly to the wound for eight weeks along with VAC therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the effect of NanoDOX Hydrogel on the healing rates of open traumatic orthopedic wounds with and without vacuum assisted closure therapy. | To determine the effect of NanoDOXâ„¢ Hydrogel in conjunction with serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and soft tissue wounds when compared to a serial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings. | participants will be followed for up to eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Analyze the molecular changes in proinflammatory cytokine levels and bioburden that occur in traumatic orthopedic and soft tissue wounds | Analyze the molecular changes in proinflammatory cytokine levels and bioburden (quantitative bacteriology and qRT-PCR for 16S rDNA) that occur in traumatic orthopedic and soft tissue wounds as a function of healing rate in the presence/absence of NanoDOXâ„¢ Hydrogel. |
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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
Agree to use a double-barrier method of contraception during their participation in this study
Abstains from sexual intercourse during their participation in this study
Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant
Have a full-thickness trauma wound that is between 1.2cm2 and 24cm2 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 wound margin.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Abernethy, MD | Alachua Government Services, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States | ||
| Univeristy of Missouri |
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| VAC Alone | Other | Patients will receive VAC therapy three time weekly for eight weeks |
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| participants will have three visits per week for up to eight weeks |
| Columbia |
| Missouri |
| 65212 |
| United States |