Sheffield Vascular Institute, University of Sheffield, UK.
Health Technol Assess. 2009 Nov;13(56):1-114, iii. doi: 10.3310/hta13560.
To examine the effectiveness and cost-effectiveness of antimicrobial silver-donating dressings for venous leg ulcers compared with simple non-adherent (also known as low-adherent) dressings.
A pragmatic, prospective randomised controlled trial (RCT) and cost-effectiveness analysis of silver-donating versus low-adherent dressings in the treatment of venous leg ulcers. A non-randomised observational group was also recruited.
Primary and secondary care services in the north and south of England (Sheffield and Exeter).
Consenting patients with active ulceration of the lower leg that had been present for a period of greater than 6 weeks.
Patients were randomised to receive either a silver-donating or non-silver low-adherent dressing applied beneath compression bandages or hosiery. The choice of dressing within these groups was left to clinician preference. Evaluation was by clinical assessment, supplemented by evaluation of quality of life and cost-effectiveness.
The primary outcome measure was complete ulcer healing at 12 weeks in the index limb. Secondary measures were costs and quality-adjusted life-years (QALYs), cost-effectiveness, time to healing, and recurrence rate at 6 months and 1 year.
In total, 304 participants were recruited to the clinical trial: 213 to the RCT and 91 to the observational arm. Within the RCT 107 were randomised to antimicrobial dressings and 106 to the control dressings. There were no significant differences (p > 0.05) between the two groups for the primary outcome measure of proportion of ulcers healed at 12 weeks (59.6% for silver and 56.7% for control dressings). The overall median time to healing was also not significantly different between the two groups (p = 0.408). A total of 24 patients had recurrent ulcers within 1 year; the recurrence rates of 11.6% (n = 11) for the antimicrobial and 14.4% (n = 13) for the control dressings were not significant. Mean utility valuations for both the EuroQol 5 dimensions (EQ-5D) quality of life questionnaire and Short Form 6 dimensions (SF-6D) utility index showed no differences for either group at 1, 3, 6 or 12 months. Compared with the control group, the antimicrobial group had an incremental cost of 97.85 pounds and an incremental QALY gain of 0.0002, giving an incremental cost-effectiveness ratio for the antimicrobial dressings of 489,250 pounds. Cost-effectiveness modelling of the results of the RCT showed that antimicrobial dressings were not cost-effective.
No significant differences in either primary or secondary end points were found between the use of antimicrobial silver-donating dressings and the control group of low-adherent dressings. Modelling showed that antimicrobial silver dressings were not cost-effective.
Current Controlled Trials ISRCTN72485131.
研究与简单非粘性（也称为低粘性）敷料相比，含银敷料治疗静脉性腿部溃疡的效果和成本效益。
一项实用的、前瞻性的随机对照试验（RCT）和含银敷料与低粘性敷料治疗静脉性腿部溃疡的成本效益分析。还招募了一个非随机观察性组。
英格兰北部和南部（谢菲尔德和埃克塞特）的初级和二级保健服务。
同意患有小腿活动性溃疡的患者，溃疡持续时间超过 6 周。
患者被随机分配接受含银或非银低粘性敷料，敷于压迫绷带或袜子下。这些组内的敷料选择留给临床医生自行决定。评估方法是临床评估，辅以生活质量和成本效益评估。
主要结局指标为 12 周时索引肢体的完全溃疡愈合。次要结果指标为成本和质量调整生命年（QALYs）、成本效益、愈合时间和 6 个月和 1 年时的复发率。
共招募了 304 名患者参加临床试验：213 名参加 RCT，91 名参加观察性手臂。在 RCT 中，107 名患者被随机分配到抗菌敷料组，106 名患者被分配到对照组。两组在 12 周时溃疡愈合比例的主要结局指标（银组为 59.6%，对照组为 56.7%）无显著差异（p>0.05）。两组的总体中位愈合时间也无显著差异（p=0.408）。共有 24 名患者在 1 年内出现复发性溃疡；抗菌组的复发率为 11.6%（n=11），对照组为 14.4%（n=13），差异无统计学意义。两组在 1、3、6 和 12 个月时的 EuroQol 5 维度（EQ-5D）生活质量问卷和简短形式 6 维度（SF-6D）效用指数的平均效用值均无差异。与对照组相比，抗菌组的增量成本为 97.85 英镑，增量 QALY 获益为 0.0002，抗菌敷料的增量成本效益比为 489,250 英镑。RCT 结果的成本效益模型表明，抗菌敷料不具有成本效益。
在使用含银抗菌敷料和低粘性敷料对照组的主要和次要终点均未发现显著差异。模型显示，含银抗菌敷料不具有成本效益。
当前对照试验 ISRCTN72485131。
