PREPARE: A Pragmatic Randomized Trial Evaluating Preoperative Antiseptic Skin Solutions in Fractured Extremities
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) represent the most severe musculoskeletal injuries. These fractures are often accompanied by soft-tissue injuries that contribute to unacceptably poor outcomes. In civilian populations, severe open injuries can lead to high infection rates up to 63%, while blast-related military fractures frequently approach 100% complication rates. Consequently, the wound complications routinely seen in military and civilian open fracture patients lead to prolonged morbidity, loss of function, and potential limb loss. Compelling data suggest simple measures may have dramatic improvements in infection outcomes, and unpublished prognostic data from our recently completed landmark trial comparing irrigation pressures and solutions for open wounds (FLOW) has shown that the type of antiseptic skin solution applied to the fractured limb in the operating room may affect outcomes. The primary rationale for the proposed Pragmatic Randomized trial Evaluating Pre-operative Antiseptic skin solutions in fRactured Extremities (PREPARE) is the need to reduce avoidable surgical site infections (SSIs) and their negative impact on US military Service members and civilian patients. Several studies, including the FLOW trial, have produced conflicting results regarding which pre-operative antiseptic solution is associated with fewer SSIs. Given the conflicting evidence and limitations in the existing literature, it is plausible that orthopaedic surgeons are routinely using a less effective solution and placing patients at much higher risk of poor outcomes. Therefore, the specific aim of this study is to determine the most effective pre-operative antiseptic skin solution to reduce SSIs during open fracture management. The secondary aim is to explore differential treatment effects for pre-operative antiseptic skin solutions among clinically important open fracture subgroups (e.g., more severe vs. less severe fractures). PREPARE is a large cluster-randomized crossover trial that will enroll 2,000 open fracture patients over 4 years across 10 hospitals to test the central hypothesis that iodophor-based pre-operative antiseptic skin solutions are more effective than chlorhexidine solutions to reduce open fracture SSIs. This clinical trial design is a novel research method where all open fracture patients treated at the recruiting hospitals will receive the predetermined study intervention prior to patient enrollment. Unlike traditional cluster randomized trial designs, the crossover method ensures each participating hospital eventually uses both treatments and acts as an internal control for the treatment groups. The order of treatment allocation for each hospital is randomly assigned. After enrollment, participants will be followed at 45 and 90 days. Our proposal is a direct response to the Gaps in Clinical Practice Guidelines focus area outlined in the Fiscal Year 2016 Peer Reviewed Orthopaedic Clinical Trial Award program announcement. Specifically, the PREPARE trial will support the Infection Prevention in Combat-Related Injuries Joint Trauma System Clinical Practice Guidelines (JTS CPGs) (CPG ID: 24). With respect to extremity injuries and open fractures, CPG 24 appropriately recommends stabilizing fractures, outlines the volume and method of washing and cleaning the wound, and describes the type and dose of antibiotics that should be administered to the patient. In other sections of the CPG, the use of antiseptic skin solutions for Intensive Care Unit (ICU) patient skin care is outlined; however, there is no guidance on the best use of antiseptic skin solutions for pre-operative open fracture care. Two other CPGs will also likely
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1710702
Entities
People
- Gerard P Slobogean
Organizations
- United States Army
- University of Maryland, Baltimore