Study design: Multicenter, single-blinded, randomized, controlled trial.
Setting: Seventeen centers in Canada and one center in Brazil.
Synopsis: Patients with a predicted annual risk of 5% of thromboembolism were randomized to continue anticoagulation with warfarin (median INR 2.3) or to bridge therapy with heparin or LMWH; they then evaluated the incidence of clinically significant hematoma requiring prolonged hospitalization, interruption of anticoagulation therapy, or further surgical intervention. After reviewing the data on 668 patients, the Data and Safety Monitoring Board recommended termination of the study given a significantly lower rate of device-pocket hematoma in the warfarin group (3.5%) compared with the bridge group (16%) with RR 0.19 (95% CI 0.10-0.36, P<0.001). Otherwise, major surgical and thromboembolic complications were rare and not significantly different in both groups.
Bottom line: Continued warfarin therapy was associated with significantly reduced incidence of device-pocket hematoma compared with bridge with heparin or LMWH.
Citation: Birnie DH, Healey JS, Wells GA, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013;368(22):2084-2093.
Prophylactic Penicillin Decreased Risk of Recurrent Leg Cellulitis
Clinical question: Does prophylactic, low-dose penicillin prevent recurrent cellulitis in patients with a history of two or more episodes of cellulitis?
Background: Some guidelines recommend prophylactic antibiotics for recurrent leg cellulitis, but there is no large randomized trial to support this practice, and clinical opinion is mixed.
Study design: Double-blinded, randomized, controlled trial.
Setting: Twenty-eight hospitals in the United Kingdom and Ireland.
Synopsis: Researchers randomized 274 patients with recurrent episodes of leg cellulitis (at least two episodes within the previous three years) to low-dose penicillin (250 mg) or placebo for 12 months and followed them for more than three years. During the prophylactic period, the penicillin group had a 45% reduction in the risk of a repeat cellulitis as compared to placebo (22% vs. 37%), equivalent to a number needed to treat to prevent a first recurrent cellulitis of five. The number of repeat episodes of cellulitis was lower overall in penicillin compared with the placebo group (119 vs. 164, P=0.02), although no significant difference was noted during the three-year follow-up period.
Factors associated with prophylaxis failure included three or more previous episodes of cellulitis, body mass index of 33 kg/m² or higher, and the presence of edema. No significant difference in adverse events was noted between the groups. Complete follow-up data was not available for participants during the follow-up period. Further study is needed to assess the long-term adverse effects and the duration of prophylaxis needed.
Bottom line: Prophylactic penicillin was effective in preventing recurrent leg cellulitis without increasing adverse effects, but its protective effect gradually declined once discontinued.
Citation: Thomas KS, Crook AM, Nunn AJ, et al. Penicillin to prevent recurrent leg cellulitis. N Engl J Med. 2013;368(18):1695-1703.
Universal ICU Decolonization Reduced Rates of MRSA Clinical Isolates and Bloodstream Infection
Clinical question: What is the most effective decolonization strategy for reducing methicillin-resistant Staphylococcus aureus (MRSA) and other pathogens in ICUs?
Background: Studies have shown that daily chlorhexidine bathing of all patients in ICUs reduced MRSA acquisition and bloodstream infection from all pathogens. However, this universal strategy has not been compared to MRSA screening and contact precautions alone, or to targeted decolonization of MRSA carriers.
Study design: Cluster-randomized comparative-effectiveness trial.
Setting: Adult ICUs in 43 Hospital Corporation of America (HCA) hospitals in 16 states.