Accelerating Treatment for Orthopaedic Trauma Wounds

The purpose of this research study is to test a new, low-cost treatment for orthopaedic trauma wounds. Severe wounds to soldiers caused by gunshots and blasts frequently occur on the arms and legs. Currently, these wounds are treated with many different techniques. One of these techniques is the use of vacuum-assisted wound closure (VAC) therapy that is placed over the wound to adjustable-pressure suction on the wound on a continuous or intermittent basis. This suction helps to keep the wound moist and to keep blood and pus from pooling. This method has been effective in improving healing and preventing infections in a variety of clinical settings. However, often VAC therapy is insufficient as a standalone treatment as wounds continue to heal slowly or develop infections.

In this research study, we are going to test the efficacy of adding a low-cost, novel topical ointment to wounds while utilizing VAC therapy. Our goal is to determine if this ointment (NanoDOX [trademark] Hydrogel) will assist in accelerating wound healing versus VAC therapy alone. We will test this hypothesis by performing a prospective, randomized (blocked 50:50) trial, having half of the patients use the VAC alone plus usual methods of treating the wound such as topical cleansing, irrigation, and surface debridement, while the other half of injured subjects will be treated with VAC plus NanoDOX Hydrogel and the usual methods. For eight weeks, we will objectively measure the residual wound, perform quantitative photo-documentation of wound status, and collect wound fluid for analysis. After eight weeks, if the wound has not healed, the soldiers in the study will go back to usual care in the hospital or clinic. During and after the study, all the information will be sent to a specialist in statistics who will evaluate the results. In the end, we hope to determine if NanoDOX Hydrogel when used in conjunction with VAC therapy for these wounds is helpful in accelerating wound healing.

If this study shows that NanoDOX Hydrogel is beneficial, the product could eventually be utilized to help anyone with a severe, open traumatic wound, although additional studies would be necessary. This type of program can take several years to result in a product that could be used by everyone including wounded soldiers and injured civilians. This project is one part of this program and will advance the research of NanoDOX Hydrogel to determine if further studies should be done and in what fashion.