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

Cirurgia para o controle de danos: Sua evolução durante os últimos 20 anos

In less than twenty years, what began as a concept for the treatment of exsanguinating truncal trauma patients has become the primary treatment model for numerous emergent, life threatening surgical conditions incapable of tolerating traditional methods. Its core concepts are relative straightforward and simple in nature: first, proper identification of the patient who is in need of following this paradigm; second, truncation of the initial surgical procedure to the minimal necessary operation; third, aggressive, focused resuscitation in the intensive care unit; fourth, definitive care only once the patient is optimized to tolerate the procedure. These simple underlying principles can be molded to a variety of emergencies, from its original application in combined major vascular and visceral trauma to the septic abdomen and orthopedics. A host of new resuscitation strategies and technologies have been developed over the past two decades, from permissive hypotension and damage control resuscitation to advanced ventilators and hemostatic agents, which have allowed for a more focused resuscitation, allowing some of the morbidity of this model to be reduced. The combination of the simple, malleable paradigm along with better understanding of resuscitation has proven to be a potent blend. As such, what was once an almost lethal injury (combined vascular and visceral injury) has become a survivable one

Does the approach to the groin make a difference in hernia repair?

PubMed ID: 17610024Background: Laparoscopic and open preperitoneal hernia repair techniques both use the preperitoneal space. This study investigated whether the surgical approach to the inguinal canal affects outcome measures. Methods: One hundred sixty patients with inguinal hernia were assigned randomly into open anterior (42), open preperitoneal (39), laparoscopic transabdominal preperitoneal (39), and laparoscopic total extraperitoneal (40) groups according to the surgical method. The peroperative serum tumor necrosis factor-? (TNF-?) levels, interleukin-6 (IL-6) levels, VAS scores at 6 and 48 h, per- and postoperative complications, and recurrence rates were determined as main variables. Results: The serum IL-6 levels were 335 ± 1.8, 283 ± 1.8, 283 ± 1.4, and 269.3 ± 1.6 pg/ml in the open anterior, posterior, transabdominal preperitoneal, and total extraperitoneal groups, respectively (P < 0.01). The TNF-? levels were highest in the open anterior group. The pain scores were lower in groups undergoing the posterior approach than in the open anterior approach group. Conclusion: The approach to the inguinal canal through the preperitoneal space appears to be less invasive than the transinguinal anterior approach. © Springer-Verlag 2007

Kinetics of serum soluble tumour necrosis factor receptor (TNF-R) type-I and type-II after a single interferon-alpha (IFN-α) injection in chronic hepatitis C

Circulating soluble TNF receptors, which act as TNF inhibitors, increase following the administration of IFN-α. Whether this is due to a direct IFN action or to indirect mechanisms involving the release of other cytokines is unclear. The kinetics of serum IFN, TNF, IL-6, IL-10, soluble TNF receptor type-I (sTNF-RI) and sTNF-RII were evaluated by enzyme immunoassays in 11 patients with chronic hepatitis C, following the first dose of recombinant human IFN-α2b (3 MU given subcutaneously). sTNF-RI concentrations paralleled IFN concentrations, rising from a mean ± s.e.m. value of 3.5 ± 0.3 ng/ml at baseline to a peak value of 5.5 ± 0.5 ng/ml after 9 h, followed by a return to 4.1 ± 0.4 ng/ml after 24 h (P = 0.0001). sTNF-RII concentrations, which were 7.6 ± 0.5 ng/ml at baseline, fell initially to 6.9 ± 0.5 ng/ml, to reach a peak at 24 h of 9.0 ± 0.7 ng/ml (P < 0.0001). In contrast, the concentrations of TNF, IL-6 and IL-10 fluctuated with no significant changes at any time point. The area under the curve (AUC) of incremental IFN values had a strong positive correlation with the AUC of incremental sTNF-RI values (r = 0.75, P < 0.01). In patients with hepatitis C, IFN concentrations reached after a single dose of IFN were paralleled by correlationally increased concentrations of sTNF-RI, which are a much better marker of administered IFN than sTNF-RII, IL-6 or IL-10