Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients

BACKGROUND: Long bone fractures, particularly of the femur, are common in multiple-trauma patients, but their optimal management has not yet been determined. Although a trend exists toward the concept of “damage control orthopedics” (DCO), current literature is inconclusive. Thus, a need exists for a more specific controlled clinical study. The primary objective of this study was to clarify whether a risk-adapted procedure for treating femoral fractures, as opposed to an early definitive treatment strategy, leads to an improved outcome (morbidity and mortality). METHODS/DESIGN: The study was designed as a randomized controlled multicenter study. Multiple-trauma patients with femur shaft fractures and a calculated probability of death of 20 to 60 % were randomized to either temporary fracture fixation with external fixation and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective was to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score. RESULTS: Thirty-four patients were randomized to two groups of 17 patients each. Both groups were comparable regarding sex, age, injury severity score, Glasgow Coma Scale, prothrombin time, base excess, calculated probability of death, and other physiologic variables. The maximum SOFA score was comparable (nonsignificant) between the groups. Regarding the secondary endpoints, the patients with external fixation required a significantly longer ventilation period (p = 0.049) and stayed on the intensive care significantly longer (p = 0.037), whereas the in-hospital length of stay was balanced for both groups. Unfortunately, the study had to be terminated prior to reaching the anticipated sample size because of unexpected low patient recruitment. CONCLUSIONS: Thus, the results of this randomized study reflect the ambivalence in the literature. No advantage of the damage control concept could be detected in the treatment of femur fractures in multiple-trauma patients. The necessity for scientific evaluation of this clinically relevant question remains. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10321620 Date assigned: 9 February 2007. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1162-2) contains supplementary material, which is available to authorized users

Дефаззификация нечеткой функции вероятности безотказной работы на примере J-образной модели надёжности

Real technical systems often operate in harsh environmental conditions thus affecting system reliability parameters, which, in this case, could be undetermined. Describing reliability parameters as fuzzy numbers, one can deal with such uncertainties. This paper provides an algorithm used to obtain crisp reliability function for systems with fuzzy reliability model parameters. J-shaped distribution is considered as an example of reliability model for random time to failure

One year ago not business as usual: Wound management, infection and psychoemotional control during tertiary medical care following the 2004 Tsunami disaster in southeast Asia

INTRODUCTION: Following the 2004 tsunami disaster in southeast Asia severely injured tourists were repatriated via airlift to Germany. One cohort was triaged to the Cologne-Merheim Medical Center (Germany) for further medical care. We report on the tertiary medical care provided to this cohort of patients. METHODS: This study is an observational report on complex wound management, infection and psychoemotional control associated with the 2004 Tsunami disaster. The setting was an adult intensive care unit (ICU) of a level I trauma center and subjects included severely injured tsunami victims repatriated from the disaster area (19 to 68 years old; 10 females and 7 males with unknown co-morbidities). RESULTS: Multiple large flap lacerations (2 × 3 to 60 × 60 cm) at various body sites were characteristic. Lower extremities were mostly affected (88%), followed by upper extremities (29%), and head (18%). Two-thirds of patients presented with combined injuries to the thorax or fractures. Near-drowning involved the aspiration of immersion fluids, marine and soil debris into the respiratory tract and all patients displayed signs of pneumonitis and pneumonia upon arrival. Three patients presented with severe sinusitis. Microbiology identified a variety of common but also uncommon isolates that were often multi-resistant. Wound management included aggressive debridement together with vacuum-assisted closure in the interim between initial wound surgery and secondary closure. All patients received empiric anti-infective therapy using quinolones and clindamycin, later adapted to incoming results from microbiology and resistance patterns. This approach was effective in all but one patient who died due to severe fungal sepsis. All patients displayed severe signs of post-traumatic stress response. CONCLUSION: Individuals evacuated to our facility sustained traumatic injuries to head, chest, and limbs that were often contaminated with highly resistant bacteria. Transferred patients from disaster areas should be isolated until their microbial flora is identified as they may introduce new pathogens into an ICU. Successful wound management, including aggressive debridement combined with vacuum-assisted closure was effective. Initial anti-infective therapy using quinolones combined with clindamycin was a good first-line choice. Psychoemotional intervention alleviated severe post-traumatic stress response. For optimum treatment and care a multidisciplinary approach is mandatory

Protocol for a randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients

<p>Abstract</p> <p>Background</p> <p>Fractures of the long bones and femur fractures in particular are common in multiple trauma patients, but the optimal management of femur fractures in these patients is not yet resolved. Although there is a trend towards the concept of "Damage Control Orthopedics" (DCO) in the management of multiple trauma patients with long bone fractures as reflected by a significant increase in primary external fixation of femur fractures, current literature is insufficient. Thus, in the era of "evidence-based medicine", there is the need for a more specific, clarifying trial.</p> <p>Methods/Design</p> <p>The trial is designed as a randomized controlled open-label multicenter study. Multiple trauma patients with femur shaft fractures and a calculated probability of death between 20 and 60% will be randomized to either temporary fracture fixation with fixateur externe and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective is to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score.</p> <p>Discussion</p> <p>The Damage Control Study is the first to evaluate the risk adapted damage control orthopedic surgery concept of femur shaft fractures in multiple trauma patients in a randomized controlled design. The trial investigates the differences in clinical outcome of two currently accepted different ways of treating multiple trauma patients with femoral shaft fractures. This study will help to answer the question whether the "early total care" or the „damage control” concept is associated with better outcome.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN10321620</p

Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients

Background: Long bone fractures, particularly of the femur, are common in multiple-trauma patients, but their optimal management has not yet been determined. Although a trend exists toward the concept of damage control orthopedics (DCO), current literature is inconclusive. Thus, a need exists for a more specific controlled clinical study. The primary objective of this study was to clarify whether a risk-adapted procedure for treating femoral fractures, as opposed to an early definitive treatment strategy, leads to an improved outcome (morbidity and mortality). Methods/Design: The study was designed as a randomized controlled multicenter study. Multiple-trauma patients with femur shaft fractures and a calculated probability of death of 20 to 60 % were randomized to either temporary fracture fixation with external fixation and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective was to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score. Results: Thirty-four patients were randomized to two groups of 17 patients each. Both groups were comparable regarding sex, age, injury severity score, Glasgow Coma Scale, prothrombin time, base excess, calculated probability of death, and other physiologic variables. The maximum SOFA score was comparable (nonsignificant) between the groups. Regarding the secondary endpoints, the patients with external fixation required a significantly longer ventilation period (p = 0.049) and stayed on the intensive care significantly longer (p = 0.037), whereas the in-hospital length of stay was balanced for both groups. Unfortunately, the study had to be terminated prior to reaching the anticipated sample size because of unexpected low patient recruitment. Conclusions: Thus, the results of this randomized study reflect the ambivalence in the literature. No advantage of the damage control concept could be detected in the treatment of femur fractures in multiple-trauma patients. The necessity for scientific evaluation of this clinically relevant question remains

Emergency trauma score:An instrument for early estimation of trauma severity

Objectives: Early estimation of the mortality risk of severely injured patients is mandatory. To estimate the seriousness of the condition of patients with trauma, we developed the emergency trauma score (EMTRAS) for ease of use, with simple parameters that are available within 30 minutes. Design: Prospective analysis of the German Trauma Registry of multitrauma patients. Setting. EMTRAS was derived from data from 1993 through 2003. Potential parameters that were prognostic for mortality in univariate analysis were evaluated by multivariate binary logistic regression. Selected parameters were then assigned a subscore that varied from 0 to 3. The EMTRAS score was a simple addition of these subscores. EMTRAS was compared with other scores' receiver operating characteristic curves. After completion, EMTRAS was validated in patients from 2004 and 2005. Patients: A total of 11,533 patients were to be used for developing the score and 3314 patients for validating it. Main Results: The strongest predictors of mortality were age, prehospital Glasgow Coma Scale, base excess (mmol/L), and prothrombin time (% of reference). These parameters were categorized in subscores of 0 through 3. Age: 75 scored 0, 1, 2, and 3, respectively. Glasgow Coma Scale: 13 through 15, 10 through 12, 6 through 9, and 3 through 5 scored 0, 1, 2, and 3, respectively. Base excess: >-1, -5 through -1, -10 through -5.1, and 20% received a score of 0, 1, 2, and 3, respectively. In the validation dataset, the area under the receiver operating characteristic curve for EMTRAS was 0.828. Conclusions: EMTRAS combines four early parameters from the emergency room and accurately predicts mortality. Knowledge of the anatomical injuries is not necessary. The determination of the EMTRAS will inform caregivers of the seriousness of patients with trauma at an early stage. (Crit Care Med 2009; 37: 1972-1977