Moore Zena Eh, Webster Joan
School of Nursing & Midwifery, Royal College of Surgeons in Ireland, 123 St. Stephen's Green, Dublin, Ireland, D2.
Cochrane Database Syst Rev. 2018 Dec 6;12(12):CD009362. doi: 10.1002/14651858.CD009362.pub3.
Pressure ulcers, localised injuries to the skin or underlying tissue, or both, occur when people cannot reposition themselves to relieve pressure on bony prominences. These wounds are difficult to heal, painful, expensive to manage and have a negative impact on quality of life. Prevention strategies include nutritional support and pressure redistribution. Dressing and topical agents aimed at prevention are also widely used, however, it remains unclear which, if any, are most effective. This is the first update of this review, which was originally published in 2013.
To evaluate the effects of dressings and topical agents on pressure ulcer prevention, in people of any age, without existing pressure ulcers, but considered to be at risk of developing one, in any healthcare setting.
In March 2017 we searched the Cochrane Wounds Group Specialised Register, CENTRAL, MEDLINE, MEDLINE (In-Process & Other Non-Indexed Citations), Embase, and EBSCO CINAHL Plus. We searched clinical trials registries for ongoing trials, and bibliographies of relevant publications to identify further eligible trials. There was no restriction on language, date of trial or setting. In May 2018 we updated this search; as a result several trials are awaiting classification.
We included randomised controlled trials that enrolled people at risk of pressure ulcers.
Two review authors independently selected trials, assessed risk of bias and extracted data.
The original search identified nine trials; the updated searches identified a further nine trials meeting our inclusion criteria. Of the 18 trials (3629 participants), nine involved dressings; eight involved topical agents; and one included dressings and topical agents. All trials reported the primary outcome of pressure ulcer incidence.Topical agentsThere were five trials comparing fatty acid interventions to different treatments. Two trials compared fatty acid to olive oil. Pooled evidence shows that there is no clear difference in pressure ulcer incidence between groups, fatty acid versus olive oil (2 trials, n=1060; RR 1.28, 95% CI 0.76 to 2.17; low-certainty evidence, downgraded for very serious imprecision; or fatty acid versus standard care (2 trials, n=187; RR 0.70, 95% CI 0.41 to 1.18; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Trials reported that pressure ulcer incidence was lower with fatty acid-containing-treatment compared with a control compound of trisostearin and perfume (1 trial, n=331; RR 0.42, 95% CI 0.22 to 0.80; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Pooled evidence shows that there is no clear difference in incidence of adverse events between fatty acids and olive oil (1 trial, n=831; RR 2.22 95% CI 0.20 to 24.37; low-certainty evidence, downgraded for very serious imprecision).Four trials compared further different topical agents with placebo. Dimethyl sulfoxide (DMSO) cream may increase the risk of pressure ulcer incidence compared with placebo (1 trial, n=61; RR 1.99, 95% CI 1.10 to 3.57; low-certainty evidence; downgraded for serious risk of bias and serious imprecision). The other three trials reported no clear difference in pressure ulcer incidence between active topical agents and control/placebo; active lotion (1 trial, n=167; RR 0.73, 95% CI 0.45 to 1.19), Conotrane (1 trial, n=258; RR 0.74, 95% CI 0.52 to 1.07), Prevasore (1 trial, n=120; RR 0.33, 95% CI 0.04 to 3.11) (very low-certainty evidence, downgraded for very serious risk of bias and very serious imprecision). There was limited evidence from one trial to determine whether the application of a topical agent may delay or prevent the development of a pressure ulcer (Dermalex 9.8 days vs placebo 8.7 days). Further, two out of 76 reactions occurred in the Dermalex group compared with none out of 91 in the placebo group (RR 6.14, 95% CI 0.29 to 129.89; very low-certainty evidence; downgraded for very serious risk of bias and very serious imprecision).DressingsSix trials (n = 1247) compared a silicone dressing with no dressing. Silicone dressings may reduce pressure ulcer incidence (any stage) (RR 0.25, 95% CI 0.16 to 0.41; low-certainty evidence; downgraded for very serious risk of bias). In the one trial (n=77) we rated as being at low risk of bias, there was no clear difference in pressure ulcer incidence between silicone dressing and placebo-treated groups (RR 1.95, 95% CI 0.18 to 20.61; low-certainty evidence, downgraded for very serious imprecision).One trial (n=74) reported no clear difference in pressure ulcer incidence when a thin polyurethane dressing was compared with no dressing (RR 1.31, 95% CI 0.83 to 2.07). In the same trial pressure ulcer incidence was reported to be higher in an adhesive foam dressing compared with no dressing (RR 1.65, 95% CI 1.10 to 2.48). We rated evidence from this trial as very low certainty (downgraded for very serious risk of bias and serious imprecision).Four trials compared other dressings with different controls. Trials reported that there was no clear difference in pressure ulcer incidence between the following comparisons: polyurethane film and hydrocolloid dressing (n=160, RR 0.58, 95% CI 0.24 to 1.41); Kang' huier versus routine care n=100; RR 0.42, 95% CI 0.08 to 2.05); 'pressure ulcer preventive dressing' (PPD) versus no dressing (n=74; RR 0.18, 95% CI 0.04 to 0.76) We rated the evidence as very low certainty (downgraded for very serious risk of bias and serious or very serious imprecision).
AUTHORS' CONCLUSIONS: Most of the trials exploring the impact of topical applications on pressure ulcer incidence showed no clear benefit or harm. Use of fatty acid versus a control compound (a cream that does not include fatty acid) may reduce the incidence of pressure ulcers. Silicone dressings may reduce pressure ulcer incidence (any stage). However the low level of evidence certainty means that additional research is required to confirm these results.
当人们无法自行改变体位以减轻骨隆突部位的压力时,就会发生压疮,即皮肤或皮下组织,或两者的局部损伤。这些伤口难以愈合,会引起疼痛,治疗费用高昂,且对生活质量有负面影响。预防策略包括营养支持和压力再分布。用于预防的敷料和外用剂也被广泛使用,然而,哪种(如果有的话)最有效仍不明确。这是本综述的首次更新,该综述最初发表于2013年。
评估敷料和外用剂对任何年龄、无现有压疮但被认为有发生压疮风险的人群在任何医疗环境中预防压疮的效果。
2017年3月,我们检索了Cochrane伤口小组专业注册库、CENTRAL、MEDLINE、MEDLINE(在研及其他未索引引文)、Embase和EBSCO CINAHL Plus。我们检索了临床试验注册库以查找正在进行的试验,并查阅了相关出版物的参考文献以识别其他符合条件的试验。对语言、试验日期或环境没有限制。2018年5月,我们更新了此检索;结果有几项试验正在等待分类。
我们纳入了纳入有压疮风险人群的随机对照试验。
两位综述作者独立选择试验、评估偏倚风险并提取数据。
最初的检索确定了9项试验;更新后的检索又确定了9项符合我们纳入标准的试验。在这18项试验(3629名参与者)中,9项涉及敷料;8项涉及外用剂;1项同时包括敷料和外用剂。所有试验均报告了压疮发生率这一主要结果。
外用剂
有5项试验将脂肪酸干预措施与不同治疗方法进行了比较。2项试验将脂肪酸与橄榄油进行了比较。汇总证据表明,脂肪酸组与橄榄油组之间在压疮发生率上没有明显差异(2项试验,n = 1060;RR 1.28,95% CI 0.76至2.17;低确定性证据,因非常严重的不精确性而降级);或者脂肪酸与标准护理相比(2项试验,n = 187;RR 0.70,95% CI 0.41至1.18;低确定性证据,因严重的偏倚风险和严重的不精确性而降级)。试验报告称,与三硬脂酸甘油酯和香料的对照化合物相比,含脂肪酸治疗的压疮发生率更低(1项试验,n = 331;RR 0.42,95% CI 0.22至0.80;低确定性证据,因严重的偏倚风险和严重的不精确性而降级)。汇总证据表明,脂肪酸与橄榄油之间在不良事件发生率上没有明显差异(1项试验,n = 831;RR 2.22,95% CI 0.20至24.37;低确定性证据,因非常严重的不精确性而降级)。
4项试验将其他不同的外用剂与安慰剂进行了比较。与安慰剂相比,二甲基亚砜(DMSO)乳膏可能会增加压疮发生率(1项试验,n = 61;RR 1.99,95% CI 1.10至3.57;低确定性证据;因严重的偏倚风险和严重的不精确性而降级)。其他3项试验报告称,活性外用剂与对照/安慰剂之间在压疮发生率上没有明显差异;活性洗剂(1项试验,n = 167;RR 0.73,95% CI 0.45至1.19)、Conotrane(1项试验,n = 258;RR 0.74,95% CI 0.52至1.07)、Prevasore(1项试验,n = 120;RR 0.33,95% CI 0.04至3.11)(极低确定性证据,因非常严重的偏倚风险和非常严重的不精确性而降级)。有一项试验的证据有限,无法确定外用剂的应用是否可能延迟或预防压疮的发生(Dermalex为9.8天,而安慰剂为8.7天)。此外,Dermalex组76例反应中有2例发生,而安慰剂组91例中无反应发生(RR 6.14,95% CI 0.29至129.89;极低确定性证据;因非常严重的偏倚风险和非常严重的不精确性而降级)。
敷料
6项试验(n = 1247)将硅胶敷料与无敷料进行了比较。硅胶敷料可能会降低压疮发生率(任何阶段)(RR 0.25,95% CI 0.16至0.41;低确定性证据;因非常严重的偏倚风险而降级)。在我们评定为低偏倚风险的一项试验(n = 77)中,硅胶敷料组与安慰剂治疗组之间在压疮发生率上没有明显差异(RR 1.95,95% CI 0.18至20.61;低确定性证据,因非常严重的不精确性而降级)。
一项试验(n = 74)报告称,薄聚氨酯敷料与无敷料相比,在压疮发生率上没有明显差异(RR 1.31,95% CI 0.83至2.07)。在同一试验中,与无敷料相比,粘性泡沫敷料的压疮发生率更高(RR 1.65,95% CI
1.10至2.48)。我们将该试验的证据评定为极低确定性(因非常严重的偏倚风险和严重的不精确性而降级)。
4项试验将其他敷料与不同对照进行了比较。试验报告称,在以下比较中,压疮发生率没有明显差异:聚氨酯薄膜与水胶体敷料(n = 160,RR 0.58,95% CI 0.24至1.41);康惠尔与常规护理(n = 100;RR 0.42,95% CI 0.08至2.05);“压疮预防敷料”(PPD)与无敷料(n = 74;RR 0.18,95% CI 0.04至0.76)。我们将证据评定为极低确定性(因非常严重 的偏倚风险和严重或非常严重的不精确性而降级)。
大多数探讨局部应用对压疮发生率影响的试验均未显示出明显的益处或危害。与对照化合物(不含脂肪酸的乳膏)相比,使用脂肪酸可能会降低压疮的发生率。硅胶敷料可能会降低压疮发生率(任何阶段)。然而,证据的低确定性意味着需要更多研究来证实这些结果。