This study compared wound healing efficacy of two silver dressings, AQUACEL(®) Ag and Urgotul(®) Silver, against venous ulcers at risk of infection, over 8 weeks of treatment. The primary objective was to show non inferiority of AQUACEL(®) Ag to Urgotul(®) Silver. Patients (281) were randomised into two groups. The AQUACEL(®) Ag group had 145 patients treated with AQUACEL(®) Ag for 4 weeks followed by AQUACEL for another 4 weeks. TheUrgotul(®) Silver group had 136 patients treated with Urgotul(®) Silver for 4 weeks followed by Urgotul(®) for another 4 weeks. In both groups, ulcer size and depth, safety events and ulcer healing were compared. After 8 weeks of treatment, the AQUACEL(®) Ag group had a relative wound size reduction (49·65% ± 52·53%) compared with the Urgotul(®) Silver group (42·81% ± 60·0%). The non inferiority of the AQUACEL(®) Ag group to the Urgotul(®) Silver group was established based on the difference between them (6·84% ± 56·3%, 95% confidence interval -6·56 to 20·2) and the pre-defined non inferiority margin (-15%). Composite wound healing analysis showed that the AQUACEL(®) Ag group had statistically higher percentage of subjects with better wound progression (66·9% versus 51·9%, P = 0·0108). In general, both dressings were effective at promoting healing of venous ulcers.
813 patients underwent aortic (AVR) or mitral valve replacement using the Carpentier-Edwards bioprosthesis from 1976 to 1983. Operative mortality was 5.49% for AVR and 4.59% for MVR. Late mortality and complications were classified using criteria described by the Stanford Group. Actuarial survival at 5 years was 87.9% +/- 2.7% for AVR and 91.1% +/- 1.4% in MVR. Thromboembolism occurred at low rates of 0.48% pt yr for AVR and 0.90% pt yr for MVR. 98.2% +/- 0.90% of AVR and 96.9% +/- 1.3% of MVR pts were free from thromboembolism at 5 years. The low incidence of thromboembolism during the early postoperative period played a role in the low rates observed in the complete study. There was no valve thrombosis. Anticoagulation with warfarin was used in 35% AVR and 75% MVR with rates of bleeding complications of 1.20% pt yr and 1.10% pt yr. Overall valve failure rate was 2.04% pt yr at 5 years for AVR and 1.55% pt yr for MVR. Rates of reoperation for tissue failure remained low (0.24% pt yr for AVR and 0.32% pt yr for MVR). The advantage of a low rate of thromboembolism was not outweighed by the specific problems of bioprosthesis at 5 years.
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