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前瞻性、随机、对照试验:聚合物电缆扎带与标准钢丝中线胸骨切开术闭合的比较。

Prospective, randomized, controlled trial of polymer cable ties versus standard wire closure of midline sternotomy.

机构信息

CJOB Cardiothoracic Surgery Department, The Alfred Hospital, Melbourne, Victoria, Australia; Department of Surgery, The Alfred Hospital, Monash University, Melbourne, Victoria, Australia.

Physiotherapy Department, The Alfred Hospital, Melbourne, Victoria, Australia.

出版信息

J Thorac Cardiovasc Surg. 2018 Oct;156(4):1589-1595.e1. doi: 10.1016/j.jtcvs.2018.04.025. Epub 2018 Apr 16.

DOI:10.1016/j.jtcvs.2018.04.025
PMID:29778340
Abstract

OBJECTIVE

Midline sternotomy remains the most common access incision for cardiac operations. Traditionally, the sternum is closed with stainless steel wires. Wires are well known to stretch and break, however, leading to pain, nonunion, and potential deep sternal wound infection. We hypothesized that biocompatible plastic cable ties would achieve a more rigid sternal fixation, reducing postoperative pain and analgesia requirements.

METHODS

A prospective, randomized study compared the ZIPFIX (De Puy Synthes, West Chester, Pa) sternal closure system (n = 58) with standard stainless steel wires (n = 60). Primary outcomes were pain and analgesia requirements in the early postoperative period. Secondary outcome was sternal movement, as assessed by ultrasound at the postoperative follow-up visit.

RESULTS

Groups were well matched in demographic and operative variables. There were no significant differences between groups in postoperative pain, analgesia, or early ventilatory requirements. Patients in the ZIPFIX group had significantly more movement in the sternum and manubrium on ultrasound at 4 weeks.

CONCLUSIONS

ZIPFIX sternal cable ties provide reliable closure but no demonstrable benefit in this study in pain or analgesic requirements relative to standard wire closure after median sternotomy.

摘要

目的

胸骨正中切开术仍然是心脏手术最常用的入路切口。传统上,胸骨采用不锈钢丝缝合。然而,众所周知,钢丝会拉伸和断裂,导致疼痛、不愈合和潜在的深部胸骨伤口感染。我们假设生物相容性塑料扎带可实现更牢固的胸骨固定,减少术后疼痛和镇痛需求。

方法

前瞻性、随机研究比较了 ZIPFIX(De Puy Synthes,宾夕法尼亚州西切斯特)胸骨闭合系统(n=58)与标准不锈钢丝(n=60)。主要结局是术后早期疼痛和镇痛需求。次要结局是通过术后随访的超声评估胸骨运动。

结果

两组在人口统计学和手术变量方面匹配良好。两组在术后疼痛、镇痛或早期通气需求方面无显著差异。在 4 周时,ZIPFIX 组的胸骨和胸骨柄在超声上的运动明显更多。

结论

在这项研究中,与标准钢丝闭合相比,ZIPFIX 胸骨扎带在胸骨正中切开术后的疼痛或镇痛需求方面没有提供可靠的益处。

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