O'Meara Susan, Martyn-St James Marrissa
Department of Health Sciences, University of York, York, UK.
Cochrane Database Syst Rev. 2013 May 31;2013(5):CD009907. doi: 10.1002/14651858.CD009907.pub2.
Venous leg ulcers are a common and recurring type of chronic or complex wound that are associated with considerable cost to patients and to healthcare providers. Primary wound contact dressings are usually applied beneath compression devices with the aim of aiding healing. Foam dressings are used frequently, and a variety of foam products is available on the market. The evidence base to guide dressing choice, however, is sparse.
To determine the effects of foam dressings on the healing of venous leg ulcers.
In October 2012 we searched The Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); the Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library); the Economic Evaluation Database (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; EBSCO CINAHL. There were no restrictions based on language or date of publication.
We included published or unpublished randomised controlled trials (RCTs) that evaluated the effects of any type of foam dressing in the treatment of venous ulcers.
Two review authors independently performed study selection, data extraction and risk of bias assessment. Meta-analysis was undertaken when deemed feasible and appropriate.
Twelve RCTs (1023 participants) reporting 14 comparisons were included in this review. There was no difference in healing outcomes between hydrocellular foam dressings and polyurethane foam dressings (three RCTs). Pooled data across five RCTs (418 participants) showed no statistically significant difference between foam dressings and hydrocolloid dressings in the proportion of ulcers healed at 12 to 16 weeks (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.81 to 1.22). No statistically significant between-group differences in healing outcomes were detected when foam dressings were compared with: paraffin gauze (two RCTs); hydrocapillary dressing (one RCT); knitted viscose dressing (one RCT); and protease modulating matrix (one RCT). No statistically significant between-group differences in the proportion of participants experiencing adverse events were detected when hydrocellular foam dressings were compared with polyurethane foam dressings, or when foam dressings were compared with hydrocapillary, hydrocolloid, or knitted viscose dressings (one RCT for each comparison). Six RCTs were considered as being at overall high risk of bias, and the remaining six RCTs were considered to be at overall unclear risk of bias. No included RCT had an overall low risk of bias.
AUTHORS' CONCLUSIONS: The current evidence base does not suggest that foam dressings are more effective in the healing of venous leg ulcers than other wound dressing treatments. The evidence in this area is of low quality. Further evidence is required from well-designed and rigorously-conducted RCTs, that employ methods to minimise bias and report them clearly, before any definitive conclusions can be made regarding the efficacy of foam dressings in the management of venous leg ulcers.
下肢静脉溃疡是一种常见的复发性慢性或复杂性伤口,给患者和医疗服务提供者带来了相当大的成本。主要伤口接触敷料通常敷于加压装置之下,旨在促进愈合。泡沫敷料使用频繁,市场上有多种泡沫产品。然而,指导敷料选择的证据基础较为薄弱。
确定泡沫敷料对下肢静脉溃疡愈合的影响。
2012年10月,我们检索了Cochrane伤口小组专业注册库;Cochrane对照试验中心注册库(CENTRAL)(Cochrane图书馆);疗效评价文摘数据库(DARE)(Cochrane图书馆);经济评价数据库(Cochrane图书馆);Ovid MEDLINE;Ovid MEDLINE(在研及其他未索引引文);Ovid EMBASE;EBSCO CINAHL。没有基于语言或出版日期的限制。
我们纳入了已发表或未发表的随机对照试验(RCT),这些试验评估了任何类型的泡沫敷料治疗静脉溃疡的效果。
两位综述作者独立进行研究选择、数据提取和偏倚风险评估。在认为可行且合适时进行荟萃分析。
本综述纳入了12项RCT(102名参与者),报告了14项比较。水凝胶泡沫敷料和聚氨酯泡沫敷料在愈合结果上没有差异(3项RCT)。五项RCT(418名参与者)的汇总数据显示,在12至16周时,泡沫敷料和水胶体敷料在溃疡愈合比例上没有统计学上的显著差异(风险比(RR)1.00,95%置信区间(CI)0.81至1.22)。当将泡沫敷料与以下敷料进行比较时,未检测到愈合结果的组间统计学显著差异:石蜡纱布(2项RCT);水毛细管敷料(1项RCT);针织粘胶敷料(1项RCT);以及蛋白酶调节基质(1项RCT)。当比较水凝胶泡沫敷料与聚氨酯泡沫敷料时,或当比较泡沫敷料与水毛细管、水胶体或针织粘胶敷料时(每项比较1项RCT),未检测到经历不良事件参与者比例的组间统计学显著差异。六项RCT被认为总体偏倚风险高,其余六项RCT被认为总体偏倚风险不明确。纳入的RCT均无总体低偏倚风险。
目前的证据基础并不表明泡沫敷料在下肢静脉溃疡愈合方面比其他伤口敷料治疗更有效。该领域的证据质量较低。在就泡沫敷料治疗下肢静脉溃疡的疗效得出任何明确结论之前,需要设计良好且严格实施的RCT提供进一步证据,这些RCT应采用方法尽量减少偏倚并清晰报告偏倚情况。