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清创剂治疗二期愈合手术伤口的临床有效性和成本效益的快速系统评价

A rapid and systematic review of the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention.

作者信息

Lewis R, Whiting P, ter Riet G, O'Meara S, Glanville J

机构信息

NHS Centre for Reviews and Dissemination, University of York, UK.

出版信息

Health Technol Assess. 2001;5(14):1-131. doi: 10.3310/hta5140.

Abstract

BACKGROUND

Most surgically sutured wounds heal without any complication. However, in some cases wound healing can be delayed due to the presence of infection or wound breakdown. This can result in the wounds becoming cavity wounds and thus necessitate healing by secondary intention. Other surgical wounds that are not sutured but left to heal by secondary intention include abscess cavities such as perianal abscesses or breast abscesses. Surgical wounds healing by secondary intention are thought to heal more slowly than wounds healing by primary intention, especially if infection is present or healing is compromised by factors such as decreased blood supply, poor nutritional status or a general suppression of the immune response. Such wounds may contain dead tissue and have a moderate or high level of exudate. Debridement involves the removal of devitalised, necrotic tissue or fibrin from a wound. There are many different methods that can be used to debride a wound, which are broadly classified as surgical/sharp, biosurgical, mechanical, chemical, enzymatic and autolytic. Although it is generally agreed that the management of surgical wounds which contain devitalised tissue and are healing by secondary intention requires debridement, it is not always clear as to what is the best method or agent to use. There is currently a large selection of products with debriding properties available on the market, which vary considerably in cost. It is important that the choice of both debriding method and product is based on the best scientific evidence available, taking into account both cost and effectiveness data.

OBJECTIVES

The review had two main objectives: (1) To determine the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention. (2) To evaluate the clinical effectiveness and cost-effectiveness of treating patients with surgical wounds healing by secondary intention at specialised wound care clinics as compared to conventional care. The review incorporated all debriding methods and any agent that is considered to have a debriding property. METHODS The following databases were searched using strategies designed specifically for each database: MEDLINE, EMBASE, CINAHL, HMIC (Health Management Information Consortium), CCTR via the Cochrane Library, the National Research Register (NRR), the NHS Economic Evaluation Database (NHS EED), and the Health Economic Evaluations Database (HEED). Additional references were identified through reviewing manufacturer and sponsor submissions made to NICE, the bibliographies of retrieved articles, and conferences proceedings on the Internet. Only randomised controlled trials (RCTs) or non-randomised controlled trials with concurrent controls and full economic evaluations were considered for inclusion. Only studies that evaluated some sort of debriding method or a specialised wound care clinic (a nurse with specialist training in wound care; care being provided by a multidisciplinary team; a fast-track referral system to other professions (e.g. dermatologist); or access to the latest health technology) were included in the review. Studies had to include participants with surgical wounds healing by secondary intention (e.g. cavity wounds, the consequences of wound dehiscence and abscesses) and report an objective measure of wound healing. Data were extracted by one reviewer and checked by a second. Quality assessment was conducted independently by two reviewers. Disagreements were resolved by consensus and, when necessary, by recourse to a third reviewer. The primary outcomes of interest were wound healing and cost. Results of data extraction and quality assessment were presented in structured tables and also as a narrative summary. In addition, where feasible, the results of individual studies were presented as forest plots. Studies were grouped according to the type of wound, debriding method and outcome measure used. RESULTS - CLINICAL EFFECTIVENESS: Seventeen trials met the inclusion criteria, all of which used the autolytic method of debridement. No studies were found that investigated sharp/surgical, biosurgical, mechanical, chemical or enzymatic debridement in the treatment of surgical wounds healing by secondary intention. No studies were found which investigated specialised wound care clinics that included the provision of care within a clinical setting (based in either primary or secondary care). The type of surgical wounds investigated by studies included in the review were those that had broken down postoperatively, perineal wounds resulting from proctolectomy or rectal excision, and those left open after pilonidal sinus excision or abscess incision, or wounds following a laparotomy. Four additional studies investigated treatment of postoperative wounds from toenail avulsions. (ABSTRACT TRUNCATED)

摘要

背景

大多数手术缝合伤口愈合时无任何并发症。然而,在某些情况下,由于感染或伤口裂开,伤口愈合可能会延迟。这可能导致伤口形成腔隙性伤口,因此需要二期愈合。其他未缝合而是任其二期愈合的手术伤口包括脓肿腔,如肛周脓肿或乳腺脓肿。人们认为,二期愈合的手术伤口比一期愈合的伤口愈合得更慢,尤其是存在感染或因诸如血液供应减少、营养状况差或免疫反应普遍受抑制等因素而影响愈合时。此类伤口可能含有坏死组织,并有中度或大量渗出物。清创术包括从伤口清除失活的、坏死的组织或纤维蛋白。有许多不同的方法可用于伤口清创,大致可分为手术/锐性清创、生物外科清创、机械清创、化学清创、酶促清创和自溶性清创。虽然人们普遍认为,对于含有失活组织且二期愈合的手术伤口的处理需要进行清创,但对于使用何种最佳方法或制剂并不总是明确的。目前市场上有大量具有清创特性的产品可供选择,其成本差异很大。重要的是,清创方法和产品的选择应基于现有最佳科学证据,并考虑成本和有效性数据。

目的

本综述有两个主要目的:(1)确定清创剂在治疗二期愈合的手术伤口中的临床有效性和成本效益。(2)评估与传统护理相比,在专科伤口护理诊所治疗二期愈合的手术伤口患者的临床有效性和成本效益。本综述纳入了所有清创方法以及任何被认为具有清创特性的制剂。

方法

使用专门为每个数据库设计的检索策略对以下数据库进行检索:医学文献数据库(MEDLINE)、荷兰医学文摘数据库(EMBASE)、护理学与健康领域数据库(CINAHL)、健康管理信息联盟数据库(HMIC)、通过考克兰图书馆检索的考克兰对照试验注册库(CCTR)、国家研究注册库(NRR)、英国国家医疗服务体系经济评估数据库(NHS EED)以及健康经济评估数据库(HEED)。通过查阅向英国国家卫生与临床优化研究所(NICE)提交的制造商和赞助商材料、检索到的文章的参考文献以及互联网上的会议论文集来识别其他参考文献。仅纳入随机对照试验(RCT)或有同期对照和全面经济评估的非随机对照试验。本综述仅纳入评估某种清创方法或专科伤口护理诊所(由接受伤口护理专科培训的护士提供护理;由多学科团队提供护理;有快速转诊至其他专业人员(如皮肤科医生)的系统;或可获取最新健康技术)的研究。研究必须纳入二期愈合的手术伤口患者(如腔隙性伤口、伤口裂开的后果以及脓肿),并报告伤口愈合的客观指标。由一名评审员提取数据,另一名评审员进行核对。由两名评审员独立进行质量评估。分歧通过协商解决,必要时求助于第三名评审员。主要关注的结局是伤口愈合和成本。数据提取和质量评估结果以结构化表格形式呈现,并附有叙述性总结。此外,在可行的情况下,将各个研究的结果以森林图形式呈现。研究根据伤口类型、清创方法和所使用的结局指标进行分组。

结果 - 临床有效性:17项试验符合纳入标准,所有试验均采用自溶性清创方法。未发现研究调查锐性/手术清创、生物外科清创、机械清创、化学清创或酶促清创在治疗二期愈合的手术伤口中的应用。未发现研究调查包括在临床环境(基于初级或二级护理)中提供护理的专科伤口护理诊所。本综述纳入的研究调查的手术伤口类型包括术后裂开的伤口、直肠切除术后的会阴伤口、藏毛窦切除或脓肿切开术后敞开的伤口或剖腹术后的伤口。另外四项研究调查了趾甲撕脱术后伤口的治疗。(摘要截断)

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