BackgroundThe goal of this proposal is to evaluate NanoDOX (trademark) Hydrogel, a 1% doxycycline monohydrate hydrogel (Nanotherapeutics, Inc.), in conjunction with vacuum-assisted wound closure (VAC), to accelerate healing of open orthopaedic trauma wounds among injured service members. This proposed effort will focus on a clinical study to investigate NanoDOX Hydrogel in an FDA-approved clinical protocol to accelerate wound healing in orthopaedic trauma wounds. This effort is clearly beneficial to wounded soldiers to return to combat readiness and other military, civilian, and VA healthcare beneficiaries to return to productive lives.Objective/HypothesisObjective 1: Determine the effect of NanoDOX Hydrogel plus Standard of Care (SoC) on the healing rates of open traumatic orthopaedic and soft tissue wounds when compared to a SoC alone in patients receiving negative pressure wound therapy/VAC in conjunction with serial wound debridement and irrigation.Objective 2: Analyze the molecular changes in proinflammatory cytokine levels and bioburden (quantitative bacteriology and qRT-PCR for 16S rDNA) that occur in traumatic orthopaedic and soft tissue wounds as a function of healing rate in the presence/absence of NanoDOX Hydrogel.Specific AimsThe primary endpoint for efficacy will be the rate of 100 percent wound closure (complete re-epithelialization of the wound surface) of the target wound(s) during the 8-week treatment study period. Secondary endpoints include the assessment of wound effluent cytokine, chemokine, protease, and patient-reported pain and quality of life.Study DesignFor this effort, Nanotherapeutics proposes to assess the safety and efficacy of local administration of NanoDOX Hydrogel in addition to VAC therapy on wound healing via an Open-Label Clinical Study of NanoDOX Hydrogel/VAC versus VAC alone for traumatic orthopaedic and soft tissue wounds.Military BenefitExtremity wounds account for a majority of all combat-related injuries in soldiers. High-energy penetrating blast wounds are especially devastating because the zone of injury is extensive, combining bone, muscle, vascular, and nerve injuries with gross bacterial contamination. Up to 75% of these injuries are colonized and/or infected with fastidious environmental bacteria when the patient arrives at tertiary military medical facilities. The increased severity and complexity of these wounds pose formidable treatment challenges. Local treatment of traumatic wounds with NanoDOX Hydrogel in conjunction with VAC stands to accelerate healing in complex traumatic wounds through further reduction in bioburden and inhibition of protease-directed destruction of endogenous growth factors, receptors, and extra-cellular matrix proteins essential to wound healing.Focus AreaThis proposal is in response to the Congressionally Directed Medical Research Programs Peer Reviewed Orthopaedic Research Program Clinical Trial Award. It is our intent to address the topic of wound healing and infection in the acute care of battle injuries by preventing complications through early prevention of infection. The project goal is to evaluate NanoDOX Hydrogel, a 1% doxycycline monohydrate hydrogel (Nanotherapeutics, Inc.), in conjunction with VAC therapy, to accelerate the healing of open trauma wounds among injured service members.
|Effective start/end date||30/09/10 → 30/09/13|
- Congressionally Directed Medical Research Programs: $658,700.00