Department of Surgery, Royal Derby Hospital, Derby, UK.
Department of Surgery and Anaesthesia, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, University of Nottingham, Derby, UK.
Cochrane Database Syst Rev. 2022 May 20;5(5):CD013439. doi: 10.1002/14651858.CD013439.pub2.
BACKGROUND: Sacrococcygeal pilonidal sinus disease is a common debilitating condition that predominantly affects young adults, with a profound impact on their activities of daily living. The condition is treated surgically, and in some cases the wound in the natal cleft is left open to heal by itself. Many dressings and topical agents are available to aid healing of these wounds. OBJECTIVES: To assess the effects of dressings and topical agents for the management of open wounds following surgical treatment for sacrococcygeal pilonidal sinus in any care setting. SEARCH METHODS: In March 2021, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and we scanned reference lists of included studies, reviews, meta-analyses and health technology reports to identify additional studies.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. SELECTION CRITERIA: We included parallel-group randomised controlled trials (RCTs) only. We included studies with participants who had undergone any type of sacrococcygeal pilonidal sinus disease surgery and were left with an open wound. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 11 RCTs comprising 932 participants. Two studies compared topical negative pressure wound therapy (TNPWT) with conventional open wound healing, two studies compared platelet-rich plasma with sterile absorbent gauze, and the other seven studies compared various dressings and topical agents. All studies were at high risk of bias in at least one domain, whilst one study was judged to be at low risk of bias in all but one domain. All studies were conducted in secondary care. Mean participant ages were between 20 and 30 years, and nearly 80% of participants were male. No studies provided data on quality of life, cost-effectiveness, pain at first dressing change or proportion of wounds healed at 6 or 12 months, and very few adverse effects were recorded in any study. It is unclear whether TNPWT reduces time to wound healing compared with conventional open wound healing (comparison 1), as the certainty of evidence is very low. The two studies provided conflicting results, with one study showing benefit (mean difference (MD) -24.01 days, 95% confidence interval (CI) -35.65 to -12.37; 19 participants), whilst the other reported no difference. It is also unclear whether TNPWT has any effect on the proportion of wounds healed by 30 days (risk ratio (RR) 3.60, 95% CI 0.49 to 26.54; 19 participants, 1 study; very low-certainty evidence). Limited data were available for our secondary outcomes time to return to normal daily activities and recurrence rate; we do not know whether TNPWT has any effect on these outcomes. Lietofix cream may increase the proportion of wounds that heal by 30 days compared with an iodine dressing (comparison 4; RR 8.06, 95% CI 1.05 to 61.68; 205 participants, 1 study; low-certainty evidence). The study did not provide data on time to wound healing. We do not know whether hydrogel dressings reduce time to wound healing compared with wound cleaning with 10% povidone iodine (comparison 5; MD -24.54 days, 95% CI -47.72 to -1.36; 31 participants, 1 study; very low-certainty evidence). The study did not provide data on the proportion of wounds healed. It is unclear whether hydrogel dressings have any effect on adverse effects as the certainty of the evidence is very low. Platelet-rich plasma may reduce time to wound healing compared with sterile absorbent gauze (comparison 6; MD -19.63 days, 95% CI -34.69 to -4.57; 210 participants, 2 studies; low-certainty evidence). No studies provided data on the proportion of wounds healed. Platelet-rich plasma may reduce time to return to normal daily activities (MD -15.49, 95% CI -28.95 to -2.02; 210 participants, 2 studies; low-certainty evidence). Zinc oxide mesh may make little or no difference to time to wound healing compared with placebo (comparison 2; median 54 days in the zinc oxide mesh group versus 62 days in the placebo mesh group; low-certainty evidence). We do not know whether zinc oxide mesh has an effect on the proportion of wounds healed by 30 days as the certainty of the evidence is very low (RR 2.35, 95% CI 0.49 to 11.23). It is unclear whether gentamicin-impregnated collagen sponge reduces time to wound healing compared with no dressing (comparison 7; MD -1.40 days, 95% CI -5.05 to 2.25; 50 participants, 1 study; very low-certainty evidence). The study did not provide data on the proportion of wounds healed. Dialkylcarbamoyl chloride (DACC)-coated dressings may make little or no difference to time to wound healing compared with alginate dressings (comparison 8; median 69 (95% CI 62 to 72) days in the DACC group versus 71 (95% CI 69 to 85) days in the alginate group; 1 study, 246 participants; low-certainty evidence). One study compared a polyurethane foam hydrophilic dressing with an alginate dressing (comparison 3) whilst another study compared a hydrocolloid dressing with an iodine dressing (comparison 9). It is unclear whether either intervention has any effect on time to wound healing as the certainty of evidence is very low. AUTHORS' CONCLUSIONS: At present, the evidence that any of the dressings or topical agents contained in this review have a benefit on time to wound healing, the proportion of wounds that heal at a specific time point or on any of the secondary outcomes of our review ranges from low certainty to very low certainty. There is low-certainty evidence on the benefit on wound healing of platelet-rich plasma from two studies and of Lietofix cream and hydrogel dressings from single studies. Further studies are required to investigate these interventions further.
背景:藏毛窦疾病是一种常见的使人衰弱的疾病,主要影响年轻人,对他们的日常生活活动有很大的影响。该疾病通过手术治疗,在某些情况下,会让会阴裂伤的伤口自行敞开愈合。有许多敷料和局部用制剂可用于帮助这些伤口愈合。 目的:评估在接受过手术治疗的藏毛窦患者中,不同的伤口处理方式(包括局部用药)对开放性伤口的愈合效果。 检索策略:2021 年 3 月,我们检索了 Cochrane 伤口专业注册库、CENTRAL、MEDLINE、Embase 和 EBSCO CINAHL Plus。我们还检索了临床试验注册库,以获取正在进行和未发表的研究,并对纳入研究的参考文献、综述、荟萃分析和卫生技术报告进行了扫描,以确定其他研究。研究没有限制语言、发表日期或研究环境。 纳入标准:我们只纳入了平行组随机对照试验(RCTs)。纳入的研究对象为接受过任何类型的藏毛窦疾病手术且留有开放性伤口的患者。 数据收集和分析:我们使用了 Cochrane 预期的标准方法学程序。我们使用 GRADE 评估了每个结局的证据确定性。 主要结果:我们纳入了 11 项 RCT,共纳入 932 名参与者。两项研究比较了局部负压伤口治疗(TNPWT)与传统的开放性伤口愈合,两项研究比较了富血小板血浆与无菌吸收性纱布,另外七项研究比较了各种敷料和局部用制剂。所有研究在至少一个领域存在高偏倚风险,而一项研究除了一个领域外,其他领域都被判断为低偏倚风险。所有研究均在二级医疗机构进行。参与者的平均年龄在 20 至 30 岁之间,近 80%的参与者为男性。没有研究提供生活质量、成本效益、首次换药时的疼痛或 6 个月或 12 个月时伤口愈合的比例数据,而且很少有研究记录了任何治疗的不良影响。目前尚不清楚 TNPWT 是否比传统的开放性伤口愈合能更快地促进伤口愈合(比较 1),因为证据的确定性非常低。两项研究的结果相互矛盾,一项研究显示有获益(MD -24.01 天,95%置信区间(CI)-35.65 至 -12.37;19 名参与者),而另一项研究则报告无差异。目前也不清楚 TNPWT 是否对 30 天内伤口愈合的比例有任何影响(RR 3.60,95%CI 0.49 至 26.54;19 名参与者,1 项研究;低确定性证据)。我们的次要结局包括伤口愈合时间和复发率,但仅获得了有限的数据;我们不确定 TNPWT 是否对这些结局有任何影响。与碘制剂相比,Lietofix 乳膏可能会增加 30 天内伤口愈合的比例(比较 4;RR 8.06,95%CI 1.05 至 61.68;205 名参与者,1 项研究;低确定性证据)。该研究没有提供伤口愈合时间的数据。我们不确定水凝胶敷料是否比用 10%聚维酮碘清洁伤口能更快地促进伤口愈合(比较 5;MD -24.54 天,95%CI -47.72 至 -1.36;31 名参与者,1 项研究;非常低确定性证据)。该研究没有提供伤口愈合比例的数据。我们不确定水凝胶敷料是否会对不良反应有任何影响,因为证据的确定性非常低。与无菌吸收性纱布相比,富血小板血浆可能会缩短伤口愈合时间(比较 6;MD -19.63 天,95%CI -34.69 至 -4.57;210 名参与者,2 项研究;低确定性证据)。没有研究提供伤口愈合比例的数据。富血小板血浆可能会缩短伤口愈合时间(MD -15.49,95%CI -28.95 至 -2.02;210 名参与者,2 项研究;低确定性证据)。锌氧化物网可能对伤口愈合时间没有影响,也可能会使伤口愈合时间稍有延长,与安慰剂相比(比较 2;锌氧化物网组的中位数为 54 天,安慰剂网组为 62 天;低确定性证据)。我们不确定锌氧化物网是否会影响 30 天内伤口愈合的比例,因为证据的确定性非常低(RR 2.35,95%CI 0.49 至 11.23)。目前尚不清楚庆大霉素浸渍胶原海绵是否比无敷料更能促进伤口愈合(比较 7;MD -1.40 天,95%CI -5.05 至 2.25;50 名参与者,1 项研究;非常低确定性证据)。该研究没有提供伤口愈合比例的数据。二烷基碳化二亚胺(DACC)涂层敷料与藻酸盐敷料相比可能对伤口愈合时间没有影响,也可能会稍有延长(比较 8;DACC 组的中位数为 69(95%CI 62 至 72)天,藻酸盐组为 71(95%CI 69 至 85)天;1 项研究,246 名参与者;低确定性证据)。一项研究比较了聚氨基甲酸酯泡沫亲水敷料与藻酸盐敷料(比较 3),另一项研究比较了水胶体敷料与碘敷料(比较 9)。目前尚不清楚这两种干预措施中的任何一种是否会对伤口愈合时间产生影响,因为证据的确定性非常低。 作者结论:目前,我们对纳入研究的任何敷料或局部用制剂在伤口愈合时间、特定时间点的伤口愈合比例或我们研究的其他结局方面是否有获益的证据,其确定性范围从低到非常低。两项研究有低确定性证据表明富血小板血浆和 Lietofix 乳膏对伤口愈合有获益,而单一研究有低确定性证据表明水凝胶敷料和碘制剂有获益。需要进一步的研究来进一步调查这些干预措施。
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