Randomized Controlled Trial Comparing Antibiotic Cement Bead Pouch Versus Negative-Pressure Wound Therapy for the Management of Severe Open Tibia Fracture Wounds (VvB)
Abstract
Injuries to the extremities (limbs) are common and frequently devastating. In combat scenarios, these injuries require the greatest use of resources to treat, cause the greatest number of disabled soldiers, and have the greatest disability benefit costs. Open fractures (broken bones that stick through the skin with substantial skin and muscle damage) represent the most severe musculoskeletal injuries. These injuries occur in both military and civilian populations, and they can lead to infection in up to 50% of grossly contaminated fractures. If an open fracture becomes infected, its treatment requires prolonged antibiotic administration, multiple surgeries, and, in worst case scenarios, amputation of the injured limb. As a result, fracture-related infection results in fracture healing difficulties, poor function, and low health-related quality of life. These outcomes are devasting to both military and civilian patients as it limits their return to function and ability to return to duty or work. Many open fractures will require more than one irrigation and debridement surgery to clean the wound. Irrigation and debridement are used to clean the open fracture wound by first removing damaged or non-living tissue followed by pouring a fluid (such as saline) into the wound to help remove foreign debris. This process helps to reduce the risk of infection and increase healing. When multiple procedures are needed, there is uncertainty on how the wound should be managed between surgeries. Negative Wound Pressure Therapy (NWPT) is currently the preferred method to manage open fracture wounds, but recent research questions the role of NPWT in open fracture wounds and preventing fracture-related infections. Moreover, emerging comparative studies suggest that the alternative method of using an antibiotic bead pouch may significantly reduce the risk of infection compared to NPWT. Both of these methods are considered to be standard-of-care, but no previous study has determined which method is better at reducing infection-related complications in patients with open fractures. Therefore, we seek to fill this critical knowledge gap by determining whether the antibiotic bead pouch, compared to NPWT, decreases infection-related complications in patients with severe open tibia fractures. Additionally, this study will explore each component of the infection-related complication ordinal scale (mortality, amputation, unplanned reoperation, pain, and ambulation), as well as to explore treatment effects for antibiotic beads and NPWT among clinically important open fracture subgroups. The proposed study is a parallel-arm, randomized, controlled trial that will enroll 440 patients with open tibia fractures requiring multiple irrigation and debridement surgeries over 24 months across 29 trauma centers to test the central hypothesis that the antibiotic bead pouch, compared to NPWT, will reduce infection-related complications within 6 months of injury. Included patients will be randomized to receive either NPWT or an antibiotic bead pouch in the operating room and followed for 6 months. The proposed trial is a direct response to the Fiscal-Year 2021 Peer Reviewed Orthopaedic Research Program focus area of fracture-related infection, and the results of our trial will address important gaps in the Joint Trauma System Clinical Practice Guidelines for the management of severe open fractures. The global importance of decreasing open fracture infections remains paramount and an area in need of clinical care improvement. The proposed trial is the next logical focus for reducing the burden of severe open tibia fracture injuries. The proposed trial will have a direct benefit to the military because it seeks to determine whether the simple antibiotic bead pouch can lower fracture-related infections by facilitating local antibiotic wound delivery. This intervention is targeted at improving management for some of the most severe fractures s
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210863
Entities
People
- Gerard P Slobogean
Organizations
- United States Army
- University of Maryland, Baltimore