Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure Therapy

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of NanoDOX™ 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.

Official Title
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A Prospective, Randomized, Open Label Trial of NanoDOX™ Hydrogel Plus Vacuum Assisted Closure Therapy Versus Vacuum Assisted Closure Therapy Alone in Orthopedic Trauma Wounds.

Conditions
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Orthopedic Trauma Wounds

Intervention / Treatment
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* Drug: NanoDOX Hydrogel
* Other: VAC Alone


Participation Criteria
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Eligibility Criteria
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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 condoms (with spermicide) and hormonal contraceptives OR condoms (with spermicide) and intrauterine device OR intrauterine device and hormonal contraceptives OR 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: Less than 18 years of age Pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control. Allergic to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative Tested positive for a doxycycline-resistant infection Have undergone treatment with systemic corticosteroid or immunosuppressive therapy in the past 2 months Currently undergoing dialysis for renal failure Have participated in another clinical research trial within the last 30 days Subject has wounds resulting from any cause other than trauma (diabetes, electrical burn, arterial insufficiency, chemical or radiation insult) Active or previous (within 60 days prior to the study screening visit) chemotherapy Active or previous (within 60 days prior to the study screening visit) radiation to the affected wound area to be treated by investigational drug or placebo Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the shock wave treatment procedure, standard-of-care self-care requirements, and all study-related follow up visit requirements. History of sickle cell anemia History of infection with Human Immunodeficiency Virus History of other immunodeficiency disorders Severe anemia - Hgb < 7 g/dl (males) or < 6.5 (females)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NanoDOX Hydrogel plus VAC<br>NanoDOX™ 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. | Drug: NanoDOX Hydrogel<br>* NanoDOX Hydrogel will be applied three time weekly to the wound for eight weeks along with VAC therapy<br>|
| Active Comparator: VAC Alone<br>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. | Other: VAC Alone<br>* Patients will receive VAC therapy three time weekly for eight weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 NanoDOX™ 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 NanoDOX™ Hydrogel. | participants will have three visits per week for up to eight weeks |