Hoogewerf Cornelis J, Hop M Jenda, Nieuwenhuis Marianne K, Oen Irma Mmh, Middelkoop Esther, Van Baar Margriet E
Dutch Burns Foundation, Beverwijk, Netherlands.
Burn Centre, Maasstad Hospital, Association of Dutch Burn Centres, Rotterdam, Netherlands.
Cochrane Database Syst Rev. 2020 Jul 29;7(7):CD008058. doi: 10.1002/14651858.CD008058.pub3.
Burn injuries are an important health problem. They occur frequently in the head and neck region. The face is the area central to a person's identity that provides our most expressive means of communication. Topical interventions are currently the cornerstone of treatment of burns to the face.
To assess the effects of topical interventions on wound healing in people with facial burns of any depth.
In December 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
Randomised controlled trials (RCTs) that evaluated the effects of topical treatment for facial burns were eligible for inclusion in this review.
Two review authors independently performed study selection, data extraction, risk of bias assessment and GRADE assessment of the certainty of the evidence.
In this first update, we included 12 RCTs, comprising 507 participants. Most trials included adults admitted to specialised burn centres after recent burn injuries. Topical agents included antimicrobial agents (silver sulphadiazine (SSD), Aquacel-Ag, cerium-sulphadiazine, gentamicin cream, mafenide acetate cream, bacitracin), non-antimicrobial agents (Moist Exposed Burn Ointment (MEBO), saline-soaked dressings, skin substitutes (including bioengineered skin substitute (TransCyte), allograft, and xenograft (porcine Xenoderm), and miscellaneous treatments (growth hormone therapy, recombinant human granulocyte-macrophage colony-stimulating factor hydrogel (rhGMCS)), enzymatic debridement, and cream with Helix Aspersa extract). Almost all the evidence included in this review was assessed as low or very low-certainty, often because of high risk of bias due to unclear randomisation procedures (i.e. sequence generation and allocation concealment); lack of blinding of participants, providers and sometimes outcome assessors; and imprecision resulting from few participants, low event rates or both, often in single studies. Topical antimicrobial agents versus topical non-antimicrobial agents There is moderate-certainty evidence that there is probably little or no difference between antimicrobial agents and non-antimicrobial agents (SSD and MEBO) in time to complete wound healing (hazard ratio (HR) 0.84 (95% confidence interval (CI) 0.78 to 1.85, 1 study, 39 participants). Topical antimicrobial agents may make little or no difference to the proportion of wounds completely healed compared with topical non-antimicrobial agents (comparison SSD and MEBO, risk ratio (RR) 0.94, 95% CI 0.68 to 1.29; 1 study, 39 participants; low-certainty evidence). We are uncertain whether there is a difference in wound infection (comparison topical antimicrobial agent (Aquacel-Ag) and MEBO; RR 0.38, 95% CI 0.12 to 1.21; 1 study, 40 participants; very low-certainty evidence). No trials reported change in wound surface area over time or partial wound healing. There is low-certainty evidence for the secondary outcomes scar quality and patient satisfaction. Two studies assessed pain but it was incompletely reported. Topical antimicrobial agents versus other topical antimicrobial agents It is uncertain whether topical antimicrobial agents make any difference in effects as the evidence is low to very low-certainty. For primary outcomes, there is low-certainty evidence for time to partial (i.e. greater than 90%) wound healing (comparison SSD versus cerium SSD: mean difference (MD) -7.10 days, 95% CI -16.43 to 2.23; 1 study, 142 participants). There is very low-certainty evidence regarding whether topical antimicrobial agents make a difference to wound infection (RR 0.73, 95% CI 0.46 to 1.17; 1 study, 15 participants). There is low to very low-certainty evidence for the proportion of facial burns requiring surgery, pain, scar quality, adverse effects and length of hospital stay. Skin substitutes versus topical antimicrobial agents There is low-certainty evidence that a skin substitute may slightly reduce time to partial (i.e. greater than 90%) wound healing, compared with a non-specified antibacterial agent (MD -6.00 days, 95% CI -8.69 to -3.31; 1 study, 34 participants). We are uncertain whether skin substitutes in general make any other difference in effects as the evidence is very low certainty. Outcomes included wound infection, pain, scar quality, adverse effects of treatment and length of hospital stay. Single studies showed contrasting low-certainty evidence. A bioengineered skin substitute may slightly reduce procedural pain (MD -4.00, 95% CI -5.05 to -2.95; 34 participants) and background pain (MD -2.00, 95% CI -3.05 to -0.95; 34 participants) compared with an unspecified antimicrobial agent. In contrast, a biological dressing (porcine Xenoderm) might slightly increase pain in superficial burns (MD 1.20, 95% CI 0.65 to 1.75; 15 participants (30 wounds)) as well as deep partial thickness burns (MD 3.00, 95% CI 2.34 to 3.66; 10 participants (20 wounds)), compared with antimicrobial agents (Physiotulle Ag (Coloplast)). Miscellaneous treatments versus miscellaneous treatments Single studies show low to very low-certainty effects of interventions. Low-certainty evidence shows that MEBO may slightly reduce time to complete wound healing compared with saline soaked dressing (MD -1.7 days, 95% CI -3.32 to -0.08; 40 participants). In addition, a cream containing Helix Aspersa may slightly increase the proportion of wounds completely healed at 14 days compared with MEBO (RR 4.77, 95% CI 1.87 to 12.15; 43 participants). We are uncertain whether any miscellaneous treatment in the included studies makes a difference in effects for the outcomes wound infection, scar quality, pain and patient satisfaction as the evidence is low to very low-certainty.
AUTHORS' CONCLUSIONS: There is mainly low to very low-certainty evidence on the effects of any topical intervention on wound healing in people with facial burns. The number of RCTs in burn care is growing, but the body of evidence is still hampered due to an insufficient number of studies that follow appropriate evidence-based standards of conducting and reporting RCTs.
烧伤是一个重要的健康问题。其经常发生在头颈部区域。面部是一个人身份的核心区域,是我们最具表现力的交流方式所在。局部干预目前是面部烧伤治疗的基石。
评估局部干预对任何深度面部烧伤患者伤口愈合的影响。
2019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(包括在研和其他未索引的引文);Ovid Embase和EBSCO CINAHL Plus。我们还检索了临床试验注册库以查找正在进行和未发表的研究,并浏览了相关纳入研究的参考文献列表以及综述、荟萃分析和卫生技术报告以识别其他研究。在语言、出版日期或研究背景方面没有限制。
评估面部烧伤局部治疗效果的随机对照试验(RCT)有资格纳入本综述。
两位综述作者独立进行研究选择、数据提取、偏倚风险评估以及证据确定性的GRADE评估。
在本次首次更新中,我们纳入了12项RCT,共507名参与者。大多数试验纳入了近期烧伤后入住专门烧伤中心的成年人。局部用药包括抗菌剂(磺胺嘧啶银(SSD)、藻酸盐银敷料(Aquacel - Ag)(译者注:原文中Aquacel - Ag为商品名,翻译时可保留原名,也可根据实际情况意译为藻酸盐银敷料等,此处保留原名)、磺胺嘧啶铈、庆大霉素乳膏、醋酸磺胺米隆乳膏、杆菌肽)、非抗菌剂(湿润烧伤膏(MEBO)、盐水浸泡敷料、皮肤替代物(包括生物工程皮肤替代物(TransCyte)、同种异体移植物和异种移植物(猪源Xenoderm))以及其他治疗方法(生长激素疗法、重组人粒细胞 - 巨噬细胞集落刺激因子水凝胶(rhGMCS))、酶清创术以及含有蛞蝓提取物的乳膏)。本综述纳入的几乎所有证据被评估为低确定性或极低确定性,通常是由于随机化程序不明确(即序列生成和分配隐藏)导致的高偏倚风险;参与者、提供者以及有时结果评估者缺乏盲法;以及由于参与者数量少、事件发生率低或两者兼而有之(通常在单个研究中)导致的不精确性。局部抗菌剂与局部非抗菌剂相比:有中等确定性证据表明,抗菌剂与非抗菌剂(SSD和MEBO)在伤口完全愈合时间上可能几乎没有差异(风险比(HR)0.84(95%置信区间(CI)0.78至1.85,1项研究,39名参与者)。与局部非抗菌剂相比(比较SSD和MEBO),局部抗菌剂对完全愈合伤口的比例可能几乎没有差异(风险比(RR)0.94,95% CI 0.68至1.29;1项研究,39名参与者;低确定性证据)。我们不确定在伤口感染方面是否存在差异(比较局部抗菌剂(Aquacel - Ag)和MEBO;RR 0.38,95% CI 0.12至1.21;1项研究,40名参与者;极低确定性证据)。没有试验报告伤口表面积随时间的变化或部分伤口愈合情况。对于次要结局瘢痕质量和患者满意度,证据确定性较低。两项研究评估了疼痛,但报告不完整。局部抗菌剂与其他局部抗菌剂相比:由于证据确定性低至极低,不确定局部抗菌剂在效果上是否有任何差异。对于主要结局,在部分(即大于90%)伤口愈合时间方面有低确定性证据(比较SSD与磺胺嘧啶铈:平均差(MD) - 7.10天,95% CI - 16.43至2.23;1项研究,142名参与者)。关于局部抗菌剂对伤口感染是否有影响,证据确定性极低(RR 0.73,95% CI 0.46至1.17;1项研究,15名参与者)。对于需要手术的面部烧伤比例、疼痛、瘢痕质量、不良反应和住院时间,证据确定性低至极低。皮肤替代物与局部抗菌剂相比:有低确定性证据表明,与未指定的抗菌剂相比,皮肤替代物可能会略微缩短部分(即大于90%)伤口愈合时间(MD - 6.00天,95% CI - 8.69至 - 3.31;1项研究,34名参与者)。由于证据确定性非常低,我们不确定一般情况下皮肤替代物在其他效果方面是否有差异。结局包括伤口感染、疼痛、瘢痕质量、治疗不良反应和住院时间。单个研究显示出相互矛盾的低确定性证据。与未指定的抗菌剂相比,生物工程皮肤替代物可能会略微减轻手术疼痛(MD - 4.00,95% CI - 5.05至 - 2.95;34名参与者)和背景疼痛(MD - 2.00,95% CI - 3.05至 - 0.95;34名参与者)。相比之下,与抗菌剂(保赫曼公司的Physiotulle Ag)相比,生物敷料(猪源Xenoderm)可能会使浅度烧伤(MD 1.20,95% CI 0.65至1.75;15名参与者(30个伤口))以及深二度烧伤(MD 3.00,95% CI 2.34至3.66;10名参与者(20个伤口))的疼痛略有增加。其他治疗方法与其他治疗方法相比:单个研究显示干预措施的效果确定性低至极低。低确定性证据表明,与盐水浸泡敷料相比,MEBO可能会略微缩短伤口完全愈合时间(MD - 1.7天,95% CI - 3.32至 - 0.08;40名参与者)。此外,与MEBO相比,含有蛞蝓提取物的乳膏可能会使14天时完全愈合伤口的比例略有增加(RR 4.77,95% CI 1.87至12.15;43名参与者)。由于证据确定性低至极低,我们不确定纳入研究中的任何其他治疗方法在伤口感染、瘢痕质量、疼痛和患者满意度结局方面的效果是否有差异。
关于任何局部干预对面部烧伤患者伤口愈合的影响,主要证据确定性低至极低。烧伤护理领域的RCT数量在增加,但由于遵循适当循证标准进行和报告RCT的研究数量不足,证据体系仍然受到阻碍。