Injury
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Randomized Controlled Trial Comparative Study
Unblinded randomized control trial on prophylactic antibiotic use in gustilo II open tibia fractures at Kenyatta National Hospital, Kenya.
To determine the difference in infection rate between 24h versus five days of prophylactic antibiotic use in management of Gustilo II open tibia fractures. ⋯ In the use of prophylactic antibiotics for the management of Gustilo II traumatic open tibia fractures, there is no difference in infection rate between 24hours and five days regimen but time to antibiotic administration correlates with infection rate. Antibiotic use for 24hours only has proven adequate prophylaxis against infection. This is underlined in our study which we hope shall inform practice in our setting. A larger, more appropriately controlled study would be useful.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Assessing protocol adherence in a clinical trial with ordered treatment regimens: Quantifying the pragmatic, randomized optimal platelet and plasma ratios (PROPPR) trial experience.
Medication dispensing errors are common in clinical trials, and have a significant impact on the quality and validity of a trial. Therefore, the definition, calculation and evaluation of such errors are important for supporting a trial's conclusions. A variety of medication dispensing errors can occur. In this paper, we focus on errors in trials where the intervention includes multiple therapies that must be given in a pre-specified order that varies across treatment arms and varies in duration. ⋯ Overall, PROPPR adherence to blood transfusion order pre-specified in the protocol was high, and the required order of transfusions for the 1:1:2 group was more difficult to achieve. The approaches proposed in this manuscript were useful in evaluating the PROPPR adherence and are potentially useful for other trials where a specific treatment orders with varying durations must be maintained.
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Randomized Controlled Trial Multicenter Study
Is distal locking with short intramedullary nails necessary in stable pertrochanteric fractures? A prospective, multicentre, randomised study.
We investigated whether a proximal femoral nail can be implanted without a distal locking screw in AO/OTA 31-A1 and 31-A2 pertrochanteric stable femur fractures. A multicentre, randomised study was conducted in six level-two trauma centres in our area (Puglia, Italy). A total of 333 patients received their allocated intervention (162 in the locking group [LG] and 171 in the unlocking group [UG]) and 266 patients were included in the final analysis at 1year. ⋯ There were also no statistically significant differences between groups for mortality and length of hospital stay. Conversely, the UG was associated with shorter operation and fluoroscopy times, shorter surgical incision length, and less blood loss and residual thigh pain. Pertrochanteric stable fractures (31-A1, 31-A2) can be treated successfully with intramedullary nails without distal locking, reducing patient and clinical personnel radiation exposure and sanitary costs (surgery time and screws costs).