Kwah Li Khim, Webb Matthew T, Goh Lina, Harvey Lisa A
Health and Social Sciences Cluster, Singapore Institute of Technology, 10 Dover Drive, Singapore, Singapore, 138683.
Cochrane Database Syst Rev. 2019 Jun 17;6(6):CD012427. doi: 10.1002/14651858.CD012427.pub2.
Dressings are part of the routine postoperative management of people after transtibial amputation. Two types of dressings are commonly used; soft dressings (e.g. elastic bandages, crepe bandages) and rigid dressings (e.g. non-removable rigid dressings, removable rigid dressings, immediate postoperative protheses). Soft dressings are the conventional dressing choice as they are cheap and easy to apply, while rigid dressings are costly, more time consuming to apply and require skilled personnel to apply the dressings. However, rigid dressings have been suggested to result in faster wound healing due to the hard exterior providing a greater degree of compression to the stump.
To assess the benefits and harms of rigid dressings versus soft dressings for treating transtibial amputations.
In December 2018 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, EBSCO CINAHL Plus, Ovid AMED and PEDro to identify relevant trials. To identify further published, unpublished and ongoing studies, we also searched clinical trial registries, the grey literature, the reference lists of relevant studies and reviews identified in prior searches. We used the Cited Reference Search facility on ThomsonReuters Web of Science and contacted relevant individuals and organisations. There were no restrictions with respect to language, date of publication or study setting.
We included randomised controlled trials (RCTs) and quasi-RCTs that enrolled people with transtibial amputations. There were no restrictions on the age of participants and reasons for amputation. Trials that compared the effectiveness of rigid dressings with soft dressings were the main focus of this review.
Two review authors independently screened titles, abstracts and full-text publications for eligible studies. Two review authors also independently extracted data on study characteristics and outcomes, and performed risk of bias and GRADE assessments.
We included nine RCTs and quasi-RCTs involving 436 participants (441 limbs). All studies recruited participants from acute and/or rehabilitation hospitals from seven different countries (the USA, Australia, Indonesia, Thailand, Canada, France and the UK). In all but one study, it was clearly stated that amputations were secondary to vascular conditions.Primary outcomes Wound healing We are uncertain whether rigid dressings decrease the time to wound healing compared with soft dressings (MD -25.60 days; 95% CI -49.08 to -2.12; one study, 56 participants); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision. It is not clear whether rigid dressings increase the proportion of wounds healed compared with soft dressings (RR 1.14; 95% CI 0.74 to 1.76; one study, 51 participants); very low-certainty evidence, downgraded twice for very high risk of bias and twice for very serious imprecision.Adverse events It is not clear whether rigid dressings increase the proportion of skin-related adverse events compared with soft dressings (RR 0.65; 95% CI 0.32 to 1.32; I = 0%; six studies, 336 participants (340 limbs)); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision.It is not clear whether rigid dressings increase the proportion of non skin-related adverse events compared with soft dressings (RR 1.09; 95% CI 0.60 to 1.99; I = 0%; six studies, 342 participants (346 limbs)); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision. In addition, we are uncertain whether rigid dressings decrease the time to no pain compared with soft dressings (MD -0.35 weeks; 95% CI -2.11 to 1.41; one study of 23 participants); very low-certainty evidence, downgraded twice for very high risk of bias and twice for very serious imprecision.Secondary outcomesWe are uncertain whether rigid dressings decrease the time to walking compared with soft dressings (MD -3 days; 95% CI -9.96 to 3.96; one study, 56 participants); very low-certainty evidence, downgraded twice for very high risk of bias and twice for very serious imprecision. We are also uncertain whether rigid dressings decrease the length of hospital stay compared with soft dressings (MD -30.10 days; 95% CI -49.82 to -10.38; one study, 56 participants); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision. It is also not clear whether rigid dressings decrease the time to readiness for prosthetic prescription and swelling compared with soft dressings, as results are based on very low-certainty evidence, downgraded twice for very high risk of bias and once/twice for serious/very serious imprecision. None of the studies reported outcomes on patient comfort, quality of life and cost.
AUTHORS' CONCLUSIONS: We are uncertain of the benefits and harms of rigid dressings compared with soft dressings for people undergoing transtibial amputation due to limited and very low-certainty evidence. It is not clear if rigid dressings are superior to soft dressings for improving outcomes related to wound healing, adverse events, prosthetic prescription, walking function, length of hospital stay and swelling. Clinicians should exercise clinical judgement as to which type of dressing they use, and consider the pros and cons of each for patients (e.g. patients with high risk of falling may benefit from the protection offered by a rigid dressing, and patients with poor skin integrity may have less risk of skin breakdown from a soft dressing).
敷料是经胫截肢术后患者常规管理的一部分。常用的敷料有两种类型;软性敷料(如弹性绷带、绉布绷带)和硬性敷料(如不可拆卸的硬性敷料、可拆卸的硬性敷料、术后即刻假肢)。软性敷料是传统的敷料选择,因为它们价格便宜且易于应用,而硬性敷料成本高、应用耗时且需要专业人员来应用。然而,有人认为硬性敷料由于其坚硬的外部能对残肢提供更大程度的压迫,从而能使伤口愈合更快。
评估硬性敷料与软性敷料治疗经胫截肢的益处和危害。
2018年12月,我们检索了Cochrane伤口专业注册库、Cochrane对照试验中心注册库(CENTRAL)、Ovid MEDLINE、Ovid Embase、EBSCO CINAHL Plus、Ovid AMED和PEDro以识别相关试验。为识别更多已发表、未发表和正在进行的研究,我们还检索了临床试验注册库、灰色文献、先前检索中识别出的相关研究和综述的参考文献列表。我们使用了汤森路透Web of Science上的被引参考文献检索工具,并联系了相关个人和组织。对语言、出版日期或研究背景没有限制。
我们纳入了纳入经胫截肢患者的随机对照试验(RCT)和半随机对照试验。对参与者的年龄和截肢原因没有限制。比较硬性敷料与软性敷料有效性的试验是本综述的主要重点。
两位综述作者独立筛选标题、摘要和全文出版物以寻找符合条件的研究。两位综述作者还独立提取关于研究特征和结果的数据,并进行偏倚风险和GRADE评估。
我们纳入了9项RCT和半随机对照试验,涉及436名参与者(441条肢体)。所有研究均从七个不同国家(美国、澳大利亚、印度尼西亚、泰国、加拿大、法国和英国)的急性和/或康复医院招募参与者。除一项研究外,所有研究均明确指出截肢继发于血管疾病。
主要结局
我们不确定与软性敷料相比,硬性敷料是否能缩短伤口愈合时间(平均差 -25.60天;95%置信区间 -49.08至 -2.12;一项研究,56名参与者);极低确定性证据,因偏倚风险极高而降级两次,因严重不精确性而降级一次。与软性敷料相比,硬性敷料是否能提高伤口愈合的比例尚不清楚(风险比1.14;95%置信区间0.74至1.76;一项研究,51名参与者);极低确定性证据,因偏倚风险极高而降级两次,因非常严重的不精确性而降级两次。
与软性敷料相比,硬性敷料是否会增加皮肤相关不良事件的比例尚不清楚(风险比0.65;95%置信区间0.32至1.32;I = 0%;六项研究,336名参与者(340条肢体));极低确定性证据,因偏倚风险极高而降级两次,因严重不精确性而降级一次。与软性敷料相比,硬性敷料是否会增加非皮肤相关不良事件的比例尚不清楚(风险比1.09;95%置信区间0.60至1.99;I = 0%;六项研究,342名参与者(346条肢体));极低确定性证据,因偏倚风险极高而降级两次,因严重不精确性而降级一次。此外,我们不确定与软性敷料相比,硬性敷料是否能缩短无痛时间(平均差 -0.35周;95%置信区间 -2.11至1.41;一项23名参与者的研究);极低确定性证据,因偏倚风险极高而降级两次,因非常严重的不精确性而降级两次。
次要结局
我们不确定与软性敷料相比,硬性敷料是否能缩短行走时间(平均差 -3天;95%置信区间 -9.96至3.96;一项研究,56名参与者);极低确定性证据,因偏倚风险极高而降级两次,因非常严重的不精确性而降级两次。我们也不确定与软性敷料相比,硬性敷料是否能缩短住院时间(平均差 -30.10天;95%置信区间 -49.82至 -10.38;一项研究,56名参与者);极低确定性证据,因偏倚风险极高而降级两次,因严重不精确性而降级一次。与软性敷料相比,硬性敷料是否能缩短假肢处方准备时间和减轻肿胀也不清楚,因为结果基于极低确定性证据,因偏倚风险极高而降级两次,因严重/非常严重的不精确性而降级一次/两次。没有研究报告患者舒适度、生活质量和成本方面的结局。
由于证据有限且确定性极低,我们不确定对于接受经胫截肢的患者,与软性敷料相比,硬性敷料的益处和危害。对于改善与伤口愈合、不良事件、假肢处方、行走功能、住院时间和肿胀相关的结局,硬性敷料是否优于软性敷料尚不清楚。临床医生应就使用哪种类型的敷料行使临床判断力,并考虑每种敷料对患者的利弊(例如,跌倒风险高的患者可能受益于硬性敷料提供的保护,而皮肤完整性差的患者使用软性敷料皮肤破损的风险可能较小)。