J Trauma
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Randomized Controlled Trial Multicenter Study
Fluid lavage of open wounds (FLOW): a multicenter, blinded, factorial pilot trial comparing alternative irrigating solutions and pressures in patients with open fractures.
Open fractures are an important source of morbidity and are associated with delayed union, nonunion, and infection. Preventing infection through meticulous irrigation and debridement is an important goal in management, and different lavage fluids and irrigation techniques (e.g., high- or low-pressure lavage) have been described for this purpose. However, there are a limited number of randomized trials comparing irrigating solutions or irrigating technique. We compared the use of castile soap versus normal saline and high- versus low-pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds. ⋯ The fluid lavage of open wounds pilot randomized controlled trial demonstrated the possibility that the use of low pressure may decrease the reoperation rate for infection, wound healing problems, or nonunion. We have demonstrated the desirability and feasibility of a definitive trial examining the effects of alternative irrigation approaches.
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Randomized Controlled Trial
A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients.
Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study. ⋯ Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence of PE and DVT in HRTPs receiving pIVCFs versus no pIVCF.
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Randomized Controlled Trial Multicenter Study Comparative Study
Recombinant activated factor VII safety in trauma patients: results from the CONTROL trial.
Safety data on recombinant activated factor VII (rFVIIa, NovoSeven; Novo Nordisk A/S, Bagsværd, Denmark) in actively hemorrhaging trauma patients are limited. We present detailed safety data from a large multicenter, randomized, placebo-controlled phase III study (the CONTROL trial). ⋯ This represents the largest placebo-controlled dataset of rFVIIa use in trauma patients to date. In this prospective study of critically bleeding trauma patients, rFVIIa use was associated with an imbalance of investigator-reported Acute myocardial infarction/non-ST segment elevation myocardial infarction (AMI/NSTEMI), but was not associated with an increased risk for other AEs, including TE complications.
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Randomized Controlled Trial Comparative Study
Brief violence interventions with community case management services are effective for high-risk trauma patients.
Currently there are few data that brief violence intervention (BVI) and community case management services (CCMS) are effective for trauma patients admitted for interpersonal violence in terms of recidivism, service utilization, or alcohol abuse. The objective of this study is to assess outcomes for a cohort of young trauma patients in a prospective, randomized trial comparing BVI with BVI + CCMS. ⋯ In-hospital BVI with community wraparound case management interventions can improve hospital and community service utilization both short- and long-term for high-risk injured patients. Longer follow-up is needed to show sustained reduction.
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Randomized Controlled Trial
Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles.
This is the first controlled study to explore whether adjunctive immersive virtual reality (VR) can reduce excessive pain of soldiers with combat-related burn injuries during wound debridement. ⋯ These preliminary results provide the first evidence from a controlled study that adjunctive immersive VR reduced pain of patients with combat-related burn injuries during severe burn wound debridement. Pain reduction during VR was greatest in patients with the highest pain during no VR. These patients were the first to use a unique custom robot-like arm mounted VR goggle system.