Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials

An amendment to this paper has been published and can be accessed via the original article

Acute Complications of Patients With Pelvic Fractures After Pelvic Angiographic Embolization

BACKGROUND: Hemodynamically unstable patients with a pelvic fracture and arterial pelvic bleeding frequently are treated with pelvic angiographic embolization (PAE). PAE is reported to be a safe and effective method of controlling hemorrhage. However, the loss of blood supply and subsequent ischemia from embolization may lead to adverse consequences. OBJECTIVES/PURPOSES: We sought to determine (1) the frequency and types of complications observed after PAE; (2) the mortality after PAE; and (3) the clinical factors associated with complications and mortality after PAE. METHODS: We conducted a retrospective case series descriptive study at a Level I trauma center. Using our institution’s trauma registry, we isolated patients with pelvic fractures treated with PAE admitted between June 1999 and December 2007. Complications attributed to PAE occurring in the initial hospital stay were recorded. We identified 98 patients with pelvic fractures treated by PAE with an average hospital stay of 25.3 days. RESULTS: The complication rate was 11% and included six patients with gluteal muscle necrosis (6%), five with surgical wound breakdown (5%), four deep infections (4%), one superficial infection, two patients with of impotence (2%), and one with bladder necrosis. The mortality rate in the PAE group reached 20%. Bilateral embolization was performed in 100% of the patients with complications. Nonselective embolization was performed in 81% of patients with complications. All of the patients with gluteal necrosis had bilateral nonselective embolization. CONCLUSIONS: Bilateral or nonselective PAE is associated with significant complications during the initial hospital stay. The value of PAE should be weighed against its possible adverse consequences. Selective unilateral arterial embolization should be considered whenever possible. LEVEL OF EVIDENCE: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence

GO-Tibia: a masked, randomized control trial evaluating gentamicin versus saline in open tibia fractures.

BackgroundThe rate of open tibia fractures is rapidly increasing across the globe due to a recent rise in road traffic accidents, predominantly in low- and low-middle-income countries. These injuries are orthopedic emergencies associated with infection rates as high as 40% despite the use of systemic antibiotics and surgical debridement. The use of local antibiotics has shown some promise in reducing the burden of infection in these injuries due to increasing local tissue availability; however, no trial has yet been appropriately powered to evaluate for definitive evidence and the majority of current studies have taken place in a high-resource countries where resources and the bio-burden may be different.MethodsThis is a prospective randomized, masked, placebo-controlled superiority trial designed to evaluate the efficacy of locally administered gentamicin versus placebo in the prevention of fracture-related infection in adults (age > 18 years) with primarily closeable Gustillo-Anderson class I, II, and IIIA open tibia fractures. Eight hundred ninety patients will be randomized to receive an injection of either gentamicin (treatment group) or saline (control group) at the site of their primarily closed open fracture. The primary outcome will be the occurrence of a fracture-related infection occurring during the course of the 12-month follow-up.DiscussionThis study will definitively assess the effectiveness of local gentamicin for the prevention of fracture-related infections in adults with open tibia fractures in Tanzania. The results of this study have the potential to demonstrate a low-cost, widely available intervention for the reduction of infection in open tibia fractures.Trial registrationClinicaltrials.gov NCT05157126. Registered on December 14, 2021

Building a Clinical Research Network in Trauma Orthopaedics: The Major Extremity Trauma Research Consortium (METRC)

OBJECTIVESLessons learned from battle have been fundamental to advancing the care of injuries that occur in civilian life. Equally important is the need to further refine these advances in civilian practice, so they are available during future conflicts. The Major Extremity Trauma Research Consortium (METRC) was established to address these needs.METHODSMETRC is a network of 22 core level I civilian trauma centers and 4 core military treatment centers-with the ability to expand patient recruitment to more than 30 additional satellite trauma centers for the purpose of conducting multicenter research studies relevant to the treatment and outcomes of orthopaedic trauma sustained in the military. Early measures of success of the Consortium pertain to building of an infrastructure to support the network, managing the regulatory process, and enrolling and following patients in multiple studies.RESULTSMETRC has been successful in maintaining the engagement of several leading, high volume, level I trauma centers that form the core of METRC; together they operatively manage 15,432 major fractures annually. METRC is currently funded to conduct 18 prospective studies that address 6 priority areas. The design and implementation of these studies are managed through a single coordinating center. As of December 1, 2015, a total of 4560 participants have been enrolled.CONCLUSIONSSuccess of METRC to date confirms the potential for civilian and military trauma centers to collaborate on critical research issues and leverage the strength that comes from engaging patients and providers from across multiple centers

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal