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预防压疮的敷料和外用制剂。

Dressings and topical agents for preventing pressure ulcers.

作者信息

Patton Declan, Moore Zena Eh, Boland Fiona, Chaboyer Wendy P, Latimer Sharon L, Walker Rachel M, Avsar Pinar

机构信息

School of Nursing & Midwifery, Royal College of Surgeons in Ireland, University of Medicine and Health Sciences, Dublin, Ireland.

Data Science Centre, School of Population Health, Royal College of Surgeons in Ireland, University of Medicine and Health Sciences, Dublin 2, Ireland.

出版信息

Cochrane Database Syst Rev. 2024 Dec 3;12(12):CD009362. doi: 10.1002/14651858.CD009362.pub4.

DOI:10.1002/14651858.CD009362.pub4
PMID:39625073
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11613325/
Abstract

BACKGROUND

Pressure ulcers occur when people cannot reposition themselves to relieve pressure over bony prominences. They are difficult to heal, costly, and reduce quality of life. Dressings and topical agents (lotions, creams, and oils) for pressure ulcer prevention are widely used. However, their effectiveness is unclear. This is the third update of this review.

OBJECTIVES

To evaluate the effects of dressings and topical agents on pressure ulcer prevention, in people of any age without existing pressure ulcers, but at risk of developing one, in any healthcare setting.

SEARCH METHODS

We used the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, two other databases, and two trial registers, together with reference checking, citation searching, and contact with study authors to identify the studies that are included in the review. The latest search date was November 2022. We imposed no restrictions on language, publication date, or setting.

SELECTION CRITERIA

We included randomised controlled trials that enroled people at risk of developing a pressure ulcer.

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methodological procedures.

MAIN RESULTS

In this update, we added 33 new studies, resulting in a total of 51 trials (13,303 participants). Of these, 31 studies involved dressings, 16 topical agents, and four included both dressings and topical agents. All trials reported the primary outcome of pressure ulcer incidence. Dressings Pressure ulcer incidence We made a total of 13 comparisons with 9027 participants. We present seven prioritised comparisons in the summary of findings (SoF) tables, as follows: silicone foam dressing versus no dressing (18 trials, 5903 participants; risk ratio (RR) 0.50, 95% confidence interval (CI) 0.33 to 0.77); foam dressing versus film dressing (3 trials, 569 participants; RR 0.72, 95% CI 0.20 to 2.67); hydrocellular foam dressing versus hydrocolloid dressing (1 trial, 80 participants; RR not estimable); silicone foam dressing type 1 versus silicone foam dressing type 2 (2 trials, 376 participants; RR 0.80, 95% CI 0.56 to 1.15); foam dressing versus fatty acid (2 trials, 300 participants; RR 1.67, 95% CI 0.49 to 5.72); polyurethane film versus hydrocolloid dressing (1 trial, 160 participants; RR 0.58, 95% CI 0.24 to 1.41); and hydrocolloid dressing versus no dressing (2 trials, 230 participants; RR 0.60, 95% CI 0.46 to 0.78). All low or very low-certainty evidence. The evidence is very uncertain about the effect of dressings on pressure ulcer development. Pressure ulcer stage Three comparisons reported pressure ulcer (PU) stage. Silicone foam dressing versus no dressing: PU stage 1 (8 trials, 1823 participants; RR 0.32, 95% CI 0.13 to 0.79); PU stage 2 (10 trials, 2873 participants; RR 0.47, 95% CI 0.30 to 0.73); PU stage 3 (3 trials, 718 participants; RR 0.45, 95% CI 0.06 to 3.21); PU stage 4 (2 trials, 610 participants; RR 0.21, 95% CI 0.02 to 1.77); unstageable PU (1 trial, 366 participants; RR 0.20, 95% CI 0.01 to 4.09); deep tissue injury (3 trials, 840 participants; RR 0.32, 95% CI 0.09 to 1.08). Foam dressing versus film dressing: PU stage 1 (1 trial, 270 participants; RR 0.56, 95% CI 0.39 to 0.80); PU stage 2 (1 trial, 270 participants; RR 1.00, 95% CI 0.06 to 15.82); deep tissue injury (1 trial, 270 participants; RR 0.67, 95% CI 0.11 to 3.93). Hydrocolloid dressing versus no dressing: PU stage 1 (1 trial, 108 participants; RR 0.54, 95% CI 0.31 to 0.94); PU stage 2 (1 trial, 108 participants; RR 0.86, 95% CI 0.28 to 2.66). All low or very low-certainty evidence. The evidence is very uncertain about the effect of dressings on different stages of pressure ulcer development. Adverse events One comparison reported adverse events: silicone foam dressing versus no dressing (3 trials, 2317 participants; RR not estimable; very low-certainty evidence). Silicone foam dressings may have little to no effect on the incidence of adverse events, but the evidence is very uncertain. Topical agents Pressure ulcer incidence We evaluated seven comparisons with 4276 participants. We present five prioritised comparisons in the SoF tables as follows: fatty acid versus placebo (6 trials, 2201 participants; RR 0.86, 95% CI 0.54 to 1.36); fatty acid versus usual care (7 trials, 1058 participants; RR 0.64, 95% CI 0.46 to 0.84); cream versus fatty acid (1 trial, 120 participants; RR 3.00, 95% CI 0.32 to 28.03); cream versus placebo (3 trials, 513 participants; RR 1.18, 95% CI 0.59 to 2.36); and cream versus usual care (1 trial, 47 participants; RR 1.60, 95% CI 0.84 to 3.04). All very low-certainty evidence. It is very uncertain whether they make any difference to PU development. Pressure ulcer stage Two comparisons reported PU stage. Fatty acid versus usual care: PU stage 1 (2 trials, 180 participants; RR 1.00, 95% CI 0.49 to 2.03); PU stage 2 (2 trials, 180 participants; RR 0.19, 95% CI 0.07 to 0.53). Cream versus placebo: PU stage 3 (1 trial, 258 participants; RR 1.25, 95% CI 0.34 to 4.55); PU stage 4 (1 trial, 258 participants; RR 0.33, 95% CI 0.01 to 8.11). Both low or very low-certainty evidence. It is uncertain whether they make any difference to the stage of PU development. Adverse events One comparison reported adverse events: fatty acid versus placebo (3 trials, 967 participants; RR 4.38, 95% CI 0.50 to 38.30; very low-certainty evidence). Fatty acid may have little to no effect on the incidence of adverse events compared to placebo, but the evidence is very uncertain. Risk of bias and imprecision were the main reasons for downgrading the certainty of the evidence.

AUTHORS' CONCLUSIONS: The included studies tested a wide variety of dressings and topical agents. The evidence for all interventions is uncertain or very uncertain; thus, it is unclear whether any of the dressings or topical agents studied make any difference to pressure ulcer development. Future studies should engage with stakeholders to determine priority interventions.

摘要

背景

当人们无法自行改变体位以减轻骨隆突处的压力时,就会发生压疮。压疮难以愈合,成本高昂,还会降低生活质量。用于预防压疮的敷料和外用制剂(洗剂、乳膏和油剂)被广泛使用。然而,其有效性尚不清楚。这是本综述的第三次更新。

目的

评估敷料和外用制剂对任何年龄段、无现有压疮但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。

检索方法

我们使用了Cochrane伤口专业注册库、Cochrane系统评价数据库、MEDLINE以及另外两个数据库和两个试验注册库,并通过参考文献核对、引文检索以及与研究作者联系,以识别纳入本综述的研究。最新检索日期为2022年11月。我们对语言、出版日期或研究背景未作限制。

选择标准

我们纳入了将有发生压疮风险的人群作为研究对象的随机对照试验。

数据收集与分析

我们采用了Cochrane标准方法程序。

主要结果

在本次更新中,我们新增了33项研究,共计51项试验(13303名参与者)。其中,31项研究涉及敷料,16项涉及外用制剂,4项同时涉及敷料和外用制剂。所有试验均报告了压疮发生率这一主要结局。

敷料

压疮发生率

我们共进行了13项比较,涉及9027名参与者。我们在结果总结(SoF)表中列出了7项优先比较,如下:硅胶泡沫敷料与无敷料(18项试验,5903名参与者;风险比(RR)0.50,95%置信区间(CI)0.33至0.77);泡沫敷料与薄膜敷料(3项试验,569名参与者;RR 0.72,95%CI 0.20至2.67);水凝胶泡沫敷料与水胶体敷料(1项试验,80名参与者;RR无法估计);1型硅胶泡沫敷料与2型硅胶泡沫敷料(2项试验,376名参与者;RR 0.80,95%CI 0.56至1.15);泡沫敷料与脂肪酸(2项试验,300名参与者;RR 1.67,95%CI 0.49至5.72);聚氨酯薄膜与水胶体敷料(1项试验,160名参与者;RR 0.58,95%CI 0.24至1.41);水胶体敷料与无敷料(2项试验,230名参与者;RR 0.60,95%CI 0.46至0.78)。所有证据的确定性均为低或极低。关于敷料对压疮发生的影响,证据非常不确定。

压疮分期

三项比较报告了压疮(PU)分期。硅胶泡沫敷料与无敷料:PU 1期(8项试验,1823名参与者;RR 0.32,95%CI 0.13至0.79);PU 2期(10项试验,2873名参与者;RR 0.

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Cochrane Database Syst Rev. 2016 Dec 15;12(12):CD011918. doi: 10.1002/14651858.CD011918.pub2.

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Effect of autologous concentrated growth factor on bedsore wounds in elderly patients with diabetes: a case-control study.自体浓缩生长因子对老年糖尿病患者褥疮伤口的影响:一项病例对照研究。
Front Endocrinol (Lausanne). 2025 Jul 18;16:1620730. doi: 10.3389/fendo.2025.1620730. eCollection 2025.
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Nursing-centered development of an AI-based decision support system in pressure ulcer and incontinence-associated dermatitis management - a mixed methods study.以护理为中心开发基于人工智能的压力性溃疡和失禁相关性皮炎管理决策支持系统——一项混合方法研究。
BMC Nurs. 2025 Jul 1;24(1):808. doi: 10.1186/s12912-025-03448-4.
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What Is the Impact of Care Bundles on the Prevalence or Incidence of Pressure Ulcers Among At-Risk Adults in the Acute Care Setting? A Systematic Review.

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A randomised controlled phase II trial to examine the feasibility of using hyper-oxygenated fatty acids (HOFA) to prevent facial pressure injuries from medical devices among adults admitted to intensive care-A research protocol.一项随机对照二期临床试验,旨在检验使用高氧脂肪酸(HOFA)预防重症监护病房成人因医疗设备导致面部压疮的可行性:研究方案。
Int Wound J. 2024 Oct;21(10):e70069. doi: 10.1111/iwj.70069.
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The effect of evidence-based skin care and hydrocolloid dressing in the prevention of nasogastric tube-related pressure injury: A randomized controlled clinical trial.循证皮肤护理和水胶体敷料预防鼻胃管相关压力性损伤的效果:一项随机对照临床试验。
J Tissue Viability. 2024 Nov;33(4):889-894. doi: 10.1016/j.jtv.2024.09.001. Epub 2024 Sep 12.
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护理集束对急症护理环境中高危成年人压疮患病率或发病率的影响是什么?一项系统评价。
Int Wound J. 2025 Jun;22(6):e70693. doi: 10.1111/iwj.70693.
EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: the EEPOC trial.预防性泡沫敷料预防高危住院患者骶部压力性损伤的效果:EEPOC 试验。
Trials. 2023 Jan 31;24(1):70. doi: 10.1186/s13063-022-06999-y.
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Use of a Sacral Foam Dressing to Prevent Pressure Injury in At-Risk Subacute Hospitalized Older Adults: A Pilot Randomized Controlled Trial.使用骶部泡沫敷料预防高危亚急性住院老年患者压力性损伤:一项试点随机对照试验。
J Wound Ostomy Continence Nurs. 2022;49(4):322-330. doi: 10.1097/WON.0000000000000894.
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Core outcomes for pressure ulcer prevention trials: results of an international consensus study: Classification: Outcomes and qualitative research.压疮预防试验的核心结局:一项国际共识研究的结果:分类:结局与定性研究
Br J Dermatol. 2022 Nov;187(5):743-752. doi: 10.1111/bjd.21741. Epub 2022 Aug 9.
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Pressure injuries in Australian public hospitals: A cost of illness study.澳大利亚公立医院的压疮:一项疾病成本研究。
Int J Nurs Stud. 2022 Jun;130:104191. doi: 10.1016/j.ijnurstu.2022.104191. Epub 2022 Feb 10.
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Comparative Evaluation of the Effect of Aloe Vera Gel, Olive Oil, and Compound Aloe Vera Gel-Olive Oil on Prevention of Pressure Ulcer: A Randomized Controlled Trial.芦荟凝胶、橄榄油及复方芦荟凝胶 - 橄榄油预防压疮效果的比较评价:一项随机对照试验
Adv Biomed Res. 2022 Jan 31;11:6. doi: 10.4103/abr.abr_121_21. eCollection 2022.
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Protective equipment-related pressure ulcers in healthcare workers during COVID-19 pandemic: A systematic review.医护人员在 COVID-19 大流行期间与防护设备相关的压力性溃疡:系统评价。
J Tissue Viability. 2022 May;31(2):213-220. doi: 10.1016/j.jtv.2022.02.004. Epub 2022 Feb 19.
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Effectiveness of a multi-layer silicone-adhesive polyurethane foam dressing as prevention for sacral pressure ulcers in at-risk in-patients: Randomized controlled trial.多层面硅酮-黏附性聚亚安酯泡沫敷料预防高危住院患者骶部压疮的效果:随机对照试验。
Int J Nurs Stud. 2022 Mar;127:104172. doi: 10.1016/j.ijnurstu.2022.104172. Epub 2022 Jan 8.
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The impact of two distinct endotracheal tube fixation on the formation of pressure ulcer in the intensive care unit: A randomised controlled trial.两种不同的气管导管固定方式对重症监护病房压力性溃疡形成的影响:一项随机对照试验。
Int Wound J. 2022 Oct;19(6):1594-1603. doi: 10.1111/iwj.13757. Epub 2022 Jan 27.