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胸骨切开术闭合中钛丝安全性的确认:一项随机前瞻性研究。

Confirmation of Safety of Titanium Wire in Sternotomy Closure, A Randomized Prospective Study.

机构信息

Klinikum Bayreuth GmbH, Bayreuth, Germany.

Department of Cardiac Surgery, Heart Center Dresden at the University Hospital Carl Gustav Carus, Dresden, Germany.

出版信息

Thorac Cardiovasc Surg. 2024 Jan;72(1):70-76. doi: 10.1055/s-0043-1764315. Epub 2023 Mar 14.

DOI:10.1055/s-0043-1764315
PMID:36918153
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10786665/
Abstract

BACKGROUND

There are many factors that are known to increase the risk of sternal wound infection (SWI); some studies have reported that nickel is a risk factor for SWI. Titanium wires have only been used as an alternative to steel wires in patients with known allergy to nickel. However, there is a paucity of literature regarding the safety of using titanium wires compared to that on the safety of steel wires for sternum closure after cardiac surgery. Therefore, this study aimed to demonstrate the noninferiority of titanium wires, even in patients without a known allergy.

METHODS

A total of 322 patients who underwent elective full median sternotomy were randomly assigned to sternal closure either by titanium wires ( = 161) or by stainless steel wires.

RESULTS

Fourteen patients had sternal instability, six (3.7%) patients in the titanium group and eight (5%) patients in the stainless steel group ( = 0.585). There was no statistically significant difference between both groups in terms of postoperative wound infection ( = 0.147). Patients in the titanium group experienced statistically significant lower postoperative pain than those in the stainless steel group ( = 0.024). The wire type was not an independent risk factor for SI, as shown by univariate and logistic regression analyses.

CONCLUSION

Titanium wires are a good alternative and have been proven to be safe and effective for sternal closure. The surgeon should be aware of the possibility of developing an allergic reaction to the wires, especially in patients with previous multiple allergic histories.

摘要

背景

有许多已知的因素会增加胸骨伤口感染(SWI)的风险;一些研究报告称镍是 SWI 的一个风险因素。钛丝仅被用于已知对镍过敏的患者中替代钢丝。然而,与心脏手术后使用钢丝进行胸骨闭合相比,关于钛丝安全性的文献很少。因此,本研究旨在证明钛丝的非劣效性,即使在没有已知过敏的患者中也是如此。

方法

共有 322 名接受择期全正中胸骨切开术的患者被随机分配到胸骨闭合组,分别使用钛丝(n=161)或不锈钢丝。

结果

14 名患者出现胸骨不稳定,钛丝组 6 名(3.7%),不锈钢丝组 8 名(5%)(=0.585)。两组术后伤口感染无统计学差异(=0.147)。钛丝组患者术后疼痛明显低于不锈钢丝组(=0.024)。单因素和逻辑回归分析显示,钢丝类型不是 SI 的独立危险因素。

结论

钛丝是一种良好的替代品,已被证明对胸骨闭合安全有效。外科医生应注意对钢丝产生过敏反应的可能性,尤其是在有多次过敏史的患者中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/10786665/5fc8888c8d4b/10-1055-s-0043-1764315-i1220226777oc-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/10786665/61a1b17c46bc/10-1055-s-0043-1764315-i1220226777oc-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/10786665/5fc8888c8d4b/10-1055-s-0043-1764315-i1220226777oc-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/10786665/61a1b17c46bc/10-1055-s-0043-1764315-i1220226777oc-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/10786665/5fc8888c8d4b/10-1055-s-0043-1764315-i1220226777oc-2.jpg

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Ann Thorac Surg. 2019 Mar;107(3):e175-e176. doi: 10.1016/j.athoracsur.2018.06.090. Epub 2018 Sep 25.
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Allergy to Surgical Implants.手术植入物过敏。
Clin Rev Allergy Immunol. 2019 Feb;56(1):72-85. doi: 10.1007/s12016-018-8707-y.
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Mitral Ring Extraction due to Nickel Allergy.二尖瓣瓣环取出术致镍过敏。
Ann Thorac Surg. 2018 Apr;105(4):e177-e178. doi: 10.1016/j.athoracsur.2017.11.048. Epub 2017 Dec 20.
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European Association for Cardio-Thoracic Surgery expert consensus statement on the prevention and management of mediastinitis.欧洲心胸外科学会关于纵隔炎预防与管理的专家共识声明
Eur J Cardiothorac Surg. 2017 Jan;51(1):10-29. doi: 10.1093/ejcts/ezw326.
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