The Journal of surgical research
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As in any area of medicine, clinical trials are crucial to the advancement of trauma care and the establishment of evidence-based guidelines. This work identifies consent regulations that impede advances in trauma resuscitation research and examines several ethical issues underlying current policies in the United States which regulate how clinical trials are conducted in an emergency setting. Trauma is a leading cause of mortality in the U.S. Minorities and those in low socioeconomic groups are subject to a disproportional amount of traumatic injuries and have worse treatment outcomes than non-minority individuals. Current regulations guiding consent requirements in emergency research were enacted to protect such vulnerable populations from exploitation. Ironically, these same regulations also serve as barriers to clinical trials in trauma research, thus depriving these same vulnerable groups from the benefits of advances in trauma care. ⋯ Given the history of past abuses in medical research, the principle of maintaining autonomy of choice is of paramount importance. However, trauma resuscitation is unique in that patients are either unconscious or of limited mental capacity at the time treatment is required, and thus the standard of informed consent is unable to be achieved as in other areas of medicine. While this paradox was recognized by the FDA in 1995 with the creation of an exception to the requirement for informed consent in emergency research (the "Common Rule"), the wording of this exception is ambiguous, and has consequently deterred trauma investigators from pursuing valuable research endeavors. In particular, the language requiring "community consultation" and demonstration that existing treatments are "unproven or unsatisfactory" have been identified as the most problematic terms to satisfactorily address by those aiming to conduct trauma research. It is imperative that the current exemptions to the Common Rule be more thoroughly operationalized, so that greater advancement in emergency medicine research can be promulgated, while concurrently maintaining a high standard of protection for the rights of trauma patients.
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A previous study has shown that brief period of repetitive superior mesenteric artery (SMA) occlusion and reperfusion applied at the onset of reperfusion, ischemic postconditioning (IPo), attenuates intestinal injury after intestinal ischemia/reperfusion (II/R). This study tested the hypothesis that IPo would attenuate II/R-induced acute lung injury, which is comparable to ischemic preconditioning (IPC) and the brief period of postconditioning applied at the onset of reperfusion is critical to pulmonary protection by IPo. ⋯ IPo at onset of reperfusion reduces acute lung injury induced by II/R, which may be mediated, in part, by inhibiting oxidant generation, neutrophils filtration, and proinflammatory mediators releases. The early period of reperfusion in the rat model is critical to pulmonary protection by IPo. IPo may improve outcome in clinical conditions associated with II/R.
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The current standard for the evaluation of children with blunt abdominal trauma (BAT) consists of physical examination, screening lab values, and computed tomography (CT) scan. We sought to determine if the focused assessment with sonography for trauma (FAST) combined with elevated liver transaminases (AST/ALT) could be used as a screening tool for intra-abdominal injury (IAI) in pediatric patients with BAT. ⋯ FAST combined with AST or ALT > 100 IU/L is an effective screening tool for IAI in children following BAT. Pediatric patients with a negative FAST and liver transaminases < 100 IU/L should be observed rather than subjected to the radiation risk of CT.
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Autologous dermal fibroblasts may be useful in the treatment of diabetic skin wounds. We hypothesized that cultured fibroblasts or cultured keratinocytes would not only survive in a hyperglycemic wound environment but also enhance the rate of re-epithelialization. We previously developed a new porcine model of delayed cutaneous wound healing in the diabetic pig. ⋯ Wounds treated with autologous fibroblasts showed a re-epithelialization rate of 86.75% and wounds treated with autologous keratinocytes showed a re-epithelialization rate of 91.3%. This is compared with a re-epithelialization rate of 56.8% seen in the normal saline treated wounds. While previous studies have shown fibroblasts suspension to have little effect in the treatment of full thickness wounds in nondiabetic wounds, this study shows a clear beneficial effect in the use of fibroblast or keratinocyte suspensions for the cutaneous healing of diabetic wounds in pigs.
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Acute intestinal ischemia reperfusion (I/R) injury affects not only the intestines but also remote organs due to pro-inflammatory and tissue injurious factors. Thus, we aimed to investigate the roles of melatonin (a powerful antioxidant) and 1400W (a strong inhibitor of inducible nitric oxide) in a rat intestinal I/R injury model, since oxidative and nitrosative injury are believed to be the major causes. ⋯ Melatonin and 1400W, either alone or in combination, were efficient in ameliorating experimental I/R injury of the intestines.