The presence of intact skin overlying a fracture distinguishes a closed fracture from an open fracture. Multiple interventions can be carried out after the first surgical debridement of the wound, including negative pressure wound therapy (NPWT), whereby an open-cell solid foam or gauze is placed over the surface of the wound and connected to a suction pump, creating a partial vacuum over the dressing and increasing the formation of granulation tissue. In this multicenter randomized controlled trial, 460 patients were randomized to receive NPWT (n=226) or standard dressings (n=234) not involving applications of negative pressure to assess disability, rate of deep infection and quality of life in patients with severe open fracture of the lower limb. The primary outcome measurement was the disability rating index score at 12 months. Only 88% of the people who were randomized completed the study. Researchers found that there were no statistically significant differences in the patients’ Disability Rating Index score at 12 months of follow-up, with a mean difference of -3.9 (95% Cl -8.9 to 1.2, p=0.13). Quality of life and the number of deep surgical site infections also did not differ when comparing NPWT with standard of care (difference 1.0%, 95% Cl -4.2% to 6.3%, p=0.64) between groups. Researchers therefore concluded that NPWT does not improve or decrease disability, infection rates, or significantly impact quality of life when compared to the standard of care. These findings do not support the use of NPWT in patients with open fracture following the first surgical debridement.
Patients with idiopathic pulmonary fibrosis (IPF) have a 5-year survival rate between 20% to 40% owing to an irreversible loss of lung function and a lack of approved therapies that slow or halt the progression of disease. The aim of this randomized controlled trial was to study the effect of recombinant human pentraxin 2 versus placebo on change in mean forced vital capacity (FVC) from baseline to week 28 in patients with IPF. Patients (n=117) were randomized to receive recombinant human pentraxin 2 (10 mg/kg IV every 4 weeks) or placebo for 24 weeks. Patients were also stratified by concurrent IPF treatment status. In terms of the primary end point, the change in FVC from baseline to week 28, researchers found that there was a statistically significant difference with the intervention at -2.5 compared to -4.8 in the placebo group (mean difference +2.3, 90% Cl 1.1 to 3.5, p=0.001). In terms of secondary end points of change in total lung volumes, quantitative parenchymal features on high-resolution computed tomography, interstitial lung abnormalities, measurements of DLCO showed no significant treatment differences. However, patients that received recombinant human pentraxin 2 demonstrated a statistically significant difference in 6-minute walk distance with a score of -0.5 meters when compared to placebo at -31.8 meters (mean difference +31.1 meters (90% Cl 17.4 meters to 45.1 meters, p<0.001). Researchers therefore concluded that recombinant human pentraxin 2 results in a slower decline in lung function over 28 weeks for patients with IPF when compared to placebo.
Self management of patients with mild COPD in primary care: randomised controlled trial
Chronic obstructive pulmonary disease (COPD) is a slow progressive lung disease that is debilitating to patients’ quality of life and associated with a heavy disease burden. This study is aimed to evaluate the effectiveness of telephone health coaching delivered by a nurse to support self-management in a primary care population with mild symptoms of COPD in patients with scores of 1 or 2 on the Medical Research Council dyspnea scale. In this multicentered randomized controlled trial, 289 patients were randomized to receive telephone health coaching while 288 patients received usual care in which they received a leaflet about self-management. The primary outcome was health related quality of life at 12 months as measured using the short version of the St. George’s Respiratory Questionnaire (SGRQ-C). Researchers found that there was no significant difference in SGRQ-C score at 12 months of follow-up between groups (mean difference of -1.3, 95% Cl -3.6 to 0.9, p=0.23). However, compared to patients in the usual care group, at 6 months follow up, the intervention group reported greater physical activity. In addition, more patients from the intervention group had received a care plan (44% vs. 30%), rescue packs of antibiotics (37% vs. 29%), and inhaler use technique checks (68% vs. 55%). This study therefore shows that self-management interventions involving health coaching may lead to behavior change in primary care patients in mild cases of COPD, although does not appear to improve health-related quality of life.
The paradigm of treatment for smoking cessation has largely remained the same despite the introduction of new drugs into the market. The lack of major advances in smoking cessation revolves around behavior support to motivate and strengthen an individual’s resolve to remain abstinent and reduce urges to smoke after quit day. This study aimed to study the effectiveness of a nicotine patch worn for 4 weeks before a quit attempt. In this randomized controlled trial, 899 patients were randomized to the preloading arm and 893 were in the control arm. All patients received standard smoking cessation pharmacotherapy and behavior support while the preloading arm also received 4 weeks of 21 mg nicotine patch before the quitting phase. The primary outcome was biochemically-confirmed prolonged abstinence at 6 months. Researchers found that 17.5% patients in the preloading arm were able to achieve abstinence while only 14.4% of patients of the control group were able to achieve abstinence (mean difference 3.0%, 95% Cl -0.4% to 6.4%, p=0.08; OR 1.25, 95% CI 0.97 to 1.62). However, there was an imbalance between groups in the frequency of varenicline use as post-cessation treatment; a planned adjustment for this produced an odds ratio use for the effect of preloading of 1.34 (95% Cl 1.03 to 1.73, p=0.03). Researchers therefore concluded that nicotine preloading does not increase subsequent smoking abstinence, most likely due to a concurrent reduction in the use of varenicline in people using nicotine preloading.
Clinical Trial of Fluid Infusion Rates for Pediatric Diabetic Ketoacidosis
For years there has been debate surrounding the side effects and consequences of intravenous fluids in children diagnosed with diabetic ketoacidosis. In particular, there is concern as it relates to brain injuries, ranging from mild to severe. In this multicentre randomized controlled trial, 1255 patients were randomized to 1 of 4 treatment groups in a 2-by-2 factorial design (0.9%, 0.45% sodium chloride content and rapid or slow rate of administration). The primary outcome was defined as a decline in mental status assessed using the Glasgow Coma Scale (GCS) during treatment for diabetic ketoacidosis. Researchers found that there was no significant difference between treatment groups with respect to the percentage of episodes in which the GCS declined to below 14, the magnitude of decline in the GCS, the duration of time in which the GCS was less than 14, he results of the tests of short-term memory, or with respect to the incidence of clinically apparent brain injury during treatment for diabetic ketoacidosis. Memory and IQ scores obtained after recovery from diabetic ketoacidosis also did not differ significantly between the groups. The GCS declined to less than 14 in 48 episodes (3.5%), and clinically apparent brain injury occurred in 12 cases (0.9%). Researchers therefore concluded that there were no significant differences in the rate of decline in mental status, the rate of clinically apparent brain injury, or in neurocognitive function after recovery from diabetic ketoacidosis among patients who received rehydration fluid at two different administration rates and with two different sodium chloride contents.
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