Moreira Silvia Silva, Camargo Mayara Costa de, Caetano Rosângela, Alves Maíra Ramos, Itria Alexander, Pereira Tiago Veiga, Lopes Luciane Cruz
Pharmaceutical Sciences Graduate Course, University of Sorocaba, UNISO, Brazil.
Department of Planning and Public Policy, Institute of Social Medicine, UERJ, Brazil.
Burns. 2022 May;48(3):568-576. doi: 10.1016/j.burns.2021.05.014. Epub 2021 Jun 1.
Nanocrystalline silver dressings can reduce the number of changes, facilitating burn wound management. However, the evidence regarding their efficacy and cost-consequences compared to well-established treatments, such as 1% silver sulfadiazine, is still scarce.
To determine the efficacy, safety, and costs of nanocrystalline silver dressings compared to 1% silver sulfadiazine dressings to treat adult patients with burns.
Randomized, single-center, single-blind trial conducted at a referral hospital in São Paulo, Brazil.
100 adult patients were randomized 1:1 to nanocrystalline silver (n = 50) or 1% silver sulfadiazine (n = 50). The primary outcome was the proportion of participants with complete re-epithelization at day 15 after randomization. Secondary outcomes included the number of dressing changes, direct medical costs (in international dollars, I$), pain intensity, the incidence of infections, number of patients undergoing surgery, and adverse events.
On day 15, the proportion of patients who reached the primary outcome did not differ significantly between participants treated with nanocrystalline silver dressings (24 [48%]) and those treated with 1% silver sulfadiazine dressings (26 [52%]); risk difference of -4.0 percentage points (95% confidence interval [CI], -17 to 9; P = 0.56). The number of patients undergoing surgical intervention was similar between groups (6% vs. 6%), and no local or serious adverse events were reported. The mean (standard deviation, SD) number of dressing changes in the nanocrystalline silver group was 4.1 (2.3), and the corresponding estimate in the 1% silver sulfadiazine group was 9.6 (6.7); mean difference of -5.56 (95% CI), -7.57 to -3.55, P < 0.001). Treatment with nanocrystalline silver dressing incurred significant cost reductions in medical materials, human resources, and administrative labor. However, the mean total cost with nanocrystalline silver dressing was higher compared to 1% silver sulfadiazine dressings: I$496.37 (445.90) vs. I$274.73 (182.76); mean difference = 221.63 (95% CI, 89.04 to 354.23, P = 0.001). The main driver of higher mean total costs among nanocrystalline silver-treated participants was the purchase cost of the dressings, representing 79.3% of the total cost in the nanocrystalline silver group but only 15.2% in the 1% silver sulfadiazine group.
We found no evidence of a difference between nanocrystalline silver and 1% silver sulfadiazine dressings regarding efficacy and safety outcomes. Nanocrystalline silver dressings were associated with an increase in the total costs, but they could result in important savings for an institution (less changes of dressings, reducing human resources burden), especially if acquisition costs can be decreased. Additional cost-effectiveness studies are warranted.
NCT02108535.
纳米晶银敷料可减少换药次数,有助于烧伤创面处理。然而,与成熟治疗方法(如1%磺胺嘧啶银)相比,其疗效及成本效益方面的证据仍较少。
比较纳米晶银敷料与1%磺胺嘧啶银敷料治疗成年烧伤患者的疗效、安全性及成本。
在巴西圣保罗一家转诊医院进行的随机、单中心、单盲试验。
100例成年患者按1:1随机分为纳米晶银组(n = 50)和1%磺胺嘧啶银组(n = 50)。主要结局为随机分组后第15天完全上皮化的参与者比例。次要结局包括换药次数、直接医疗成本(国际美元,I$)、疼痛强度、感染发生率、接受手术的患者数量及不良事件。
第15天,纳米晶银敷料治疗的参与者(24例[48%])与1%磺胺嘧啶银敷料治疗的参与者(26例[52%])达到主要结局的比例无显著差异;风险差为-4.0个百分点(95%置信区间[CI],-17至9;P = 0.56)。两组接受手术干预的患者数量相似(6%对6%),未报告局部或严重不良事件。纳米晶银组换药次数的均值(标准差,SD)为4.1(2.3),1%磺胺嘧啶银组相应估计值为9.6(6.7);均值差为-5.