Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial
Abstract
This application is a direct response to the fiscal year 2022 Focus Area Retention Strategies Return to Duty. Injuries to the arms and legs sustained in battle commonly involve broken bones with severe soft tissue injury and/or open wounds (open fracture). Improvements in body armor and rescue strategies have increased the number of survivors of combat-related injuries. An unintended consequence of improved survival is an increase the number of wounded warriors severe injuries that are at high risk for infectious and/or wound-healing complications. The negative functional consequences of these complications are profound, resulting in delayed rate of recovery and inferior outcomes in terms of pain, physical function, health care expenditure, and cost to society (including increased disability and reduction in ability to return to active duty or other work activities). Incisional Negative Pressure Wound Therapy (NPWT) is a closed, sealed wound management system that applies negative pressure (suction) at the closed wound surface. This provides a sealed environment that prevents contamination from the external environment, helps improve blood flow to the healing wound, helps manage drainage from the wound, and reduces tension on the closed incision. This wound dressing can be easily deployed in a field-forward manner. Based on the current literature, incisional NPWT appears to be effective at reducing complications in patients who have injuries at high risk for complication. However, there remain gaps in the literature, which contribute to practice variation. Based on these gaps, a well-designed multicenter clinical trial focusing on patients with who are at high risk for complication is urgently needed. This proposal represents the next step toward demonstrating efficacy, paving the way for wider adoption with a reduction in complications, improved outcomes, and earlier return to duty and/or work. In this multicenter randomized clinical trial including 352 patients with high-risk injuries, we will compare the incidence of complications within 12 months in patients treated with incisional NPWT versus those treated with standard-of-care wound dressing. We will compare both health care costs and societal costs between these two groups. Lastly, among patients who develop infection, we will compare the infection microbiome between patients treated with incisional NPWT and those treated with standard-of-care wound dressing. At the completion of this trial, we will have demonstrated efficacy of incisional NPWT in a high-risk patient population. We will also demonstrate benefit with regard to both societal and health care costs and will better understand an important component of the mechanism underlying the effect of NPWT. We anticipate that this trial will have an enormous impact on clinical practice, providing both military and civilian surgeons with critical information around efficacy and indications/best practices. Following the completion of this trial, it is anticipated to have an immediate substantial military benefit and clinical impact on the care and outcome of patients with severe lower-extremity fractures. Critical to regaining normal lifestyle and returning to active duty is having a highly functional limb, which can be achieved more frequently and reliably when complications are prevented. We believe that this work will pave the way for clearer clinical indications and widespread adoption of this field-forward, easy-to-implement intervention.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310357
Entities
People
- Ida Gitajn
Organizations
- Dartmouth–Hitchcock Medical Center
- United States Army