Prevention of Trauma-Related Infections During Prolonged Care
Abstract
Objectives and Rationale: Open bone fractures are the most common injury sustained by Warfighters on the battlefield. According to military treatment guidelines these types of injuries are best treated with special external metal frames and/or vacuum assisted wound dressings with the ability to stabilize the bone and soft tissue during evacuation from the combat zone. Overall, this process helps mitigate the risk of severe wound healing complications in the long run. In terms of the external fixation devices, the load-bearing capacities of the bone are transferred to an external rod by metal pins that are directly inserted through the soft tissue and into the bone. The points where these pins enter the tissue or affix to the bone are highly prone to become infected. Especially during prolonged care these infections increase the risk of impaired functional outcomes, including the possibility of amputation or even death. In terms of the vacuum-assisted wound dressings, they have shown to be superior to conventional wound dressings. Yet, their use in combination with external fixation system has not been optimized in terms of usability placing additional burden on the already overwhelmed medical team. In this project, we propose to provide antibacterial external fixation systems capable of reducing the risk of infection. Furthermore, we want to make the use of vacuum assisted wound dressings easier to use in combination with these systems. Focus Areas: According to the clinical needs outlined in the DOD FY22 DMRDP BWMIR Award, we wish to provide solutions suitable to deal with combat traumatic wound infections in a prolonged care environment. With infection rates of combat wounds being greater than 30% and expected to rise in a prolonged care environment dedicated solutions and technologies, such as the ones outlined in this project are essential. In terms of the FY22 DMRDP BWMIR Focus Areas, the proposed project focuses on Understanding appropriate wound prophylaxis strategies throughout continuum of care, regardless of injury status, through preclinical and clinical studies to inform clinical practice guidelines for: managing complex fractures and expanding the understanding of antibiotic use and covers aspects of two other areas. Applications, Benefits, and Risks: The proposed device could be used in any clinical setting where external fixation of a fracture (open or closed) is required, including both combat and civilian uses. The primary benefit of the proposed advance in medical care is a reduction in infections associated with external fixation devices. The surface technology utilized in this project has shown to be effective in selected patients (compassionate care) and is not expected to have any additional risks compared to the current fixation devices. Transition Plan: Upon completion of the project, the industrial partners of the project expect to have the necessary evidence in order to submit the collective evidence to the FDA and request market clearance, which would allow commercialization of the new system without additional clinical testing. This is possible due to the high maturity level of the combined technologies. Impact on Service Members and/or Public: By leveraging existing external fixation devices already used by military personnel and a medical-grade coating that has been shown to be safe in humans, the work is expected to rapidly deliver a solution to substantially reduce trauma related infection in both military and civilian settings where external fixation is used to stabilize fractures. The proposed technology has the potential to be established as a new standard of care. The project will also serve as a model for rapid translation of antibacterial coatings for use in the field of medicine and will broaden the application of NPWT.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252311078
Entities
People
- Samir Mehta
Organizations
- United States Army
- University of Pennsylvania