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PINS 试验:一项前瞻性随机临床试验,比较传统与保湿护肤品方案在圆形眼眶患者眶周穿刺部位护理中的应用。

The PINS Trial: a prospective randomized clinical trial comparing a traditional versus an emollient skincare regimen for the care of pin-sites in patients with circular frames.

机构信息

Trauma & Orthopaedics, James Cook University Hospital, Middlesbrough, UK.

Limb Reconstruction Unit, Leeds General Infirmary, Leeds, UK.

出版信息

Bone Joint J. 2021 Feb;103-B(2):279-285. doi: 10.1302/0301-620X.103B2.BJJ-2020-0680.R1.

DOI:10.1302/0301-620X.103B2.BJJ-2020-0680.R1
PMID:33517738
Abstract

AIMS

Pin-site infection remains a significant problem for patients treated by external fixation. A randomized trial was undertaken to compare the weekly use of alcoholic chlorhexidine (CHX) for pin-site care with an emollient skin preparation in patients with a tibial fracture treated with a circular frame.

METHODS

Patients were randomized to use either 0.5% CHX or Dermol (DML) 500 emollient pin-site care. A skin biopsy was taken from the tibia during surgery to measure the dermal and epidermal thickness and capillary, macrophage, and T-cell counts per high-powered field. The pH and hydration of the skin were measured preoperatively, at follow-up, and if pin-site infection occurred. Pin-site infection was defined using a validated clinical system.

RESULTS

Out of 116 patients who were enrolled in the study, 23 patients (40%) in the CHX group and 26 (44%) in the DML group had at least one bad or ugly pin-site infection. This difference was not statistically significant (p = 0.71). There was no significant relationship between pH or hydration of the skin and pin-site infection. The epidermal thickness was found to be significantly greater in patients who had a pin-site infection compared with those who did not (p = 0.01). Skin irritation requiring a change of treatment occurred in four patients (7%) using CHX, and none using DML.

CONCLUSION

We found no significant difference in the incidence of pin-site infection between the CHX and DML treatment groups. Dermol appeared to offer a small but significant advantage in terms of tolerability. We did not find a significant association between patient or treatment related factors and pin-site infection. It is therefore difficult to make specific recommendations based upon these results. The use of either cleaning agent appears to be appropriate. Cite this article: 2021;103-B(2):279-285.

摘要

目的

经皮外固定治疗的患者,针道感染仍然是一个严重的问题。本研究采用随机对照试验,比较了每周使用酒精氯己定(CHX)和润肤剂 Dermol(DML)对环形外固定架固定胫骨骨折患者的针道护理效果。

方法

患者被随机分为 CHX 组或 Dermol 组,分别使用 0.5% CHX 或 Dermol 500 进行针道护理。在手术时从胫骨上取皮肤活检,以测量真皮和表皮厚度以及每高倍视野的毛细血管、巨噬细胞和 T 细胞计数。在术前、随访时和出现针道感染时测量皮肤的 pH 值和水合作用。采用验证的临床系统定义针道感染。

结果

在纳入研究的 116 例患者中,23 例(40%)CHX 组和 26 例(44%)DML 组至少有 1 例不良或难看的针道感染。差异无统计学意义(p = 0.71)。皮肤 pH 值或水合作用与针道感染无显著关系。与未发生针道感染的患者相比,发生针道感染的患者表皮厚度显著增加(p = 0.01)。使用 CHX 的患者中有 4 例(7%)出现皮肤刺激,需要改变治疗,而使用 DML 的患者中无一例出现。

结论

我们发现 CHX 组和 DML 组之间针道感染的发生率无显著差异。Dermol 在耐受性方面有一定优势。我们没有发现患者或治疗相关因素与针道感染之间存在显著关联。因此,根据这些结果很难提出具体建议。使用这两种清洁剂似乎都是合适的。 引用本文:2021;103-B(2):279-285.

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