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全髋关节置换术后伤口并发症:一项比较吻合钉与缝线的前瞻性随机对照试验。

Wound complications after total hip arthroplasty: a prospective, randomised controlled trial comparing staples with sutures.

作者信息

Mallee Wouter H, Wijsbek Anne E, Schafroth Matthias U, Wolkenfelt Julius, Baas Dominique C, Vervest Ton M J S

机构信息

Department of Orthopaedic surgery, Academic Medical Centre, Amsterdam, The Netherlands.

Department of Orthopaedic surgery, Tergooi Hospital, Hilversum, The Netherlands.

出版信息

Hip Int. 2025 Jul;35(4):326-331. doi: 10.1177/1120700020939075. Epub 2020 Jul 7.

DOI:10.1177/1120700020939075
PMID:32634064
Abstract

OBJECTIVE

Does the use of staples or sutures for wound closure have a lower surgical site infection rate in patients receiving primary total hip arthroplasty (THA)?

DESIGN

Prospective, randomised controlled multicentre trial.

METHODS

535 patients undergoing THA were included and randomised into 2 groups: 268 wounds were closed with staples, and 267 with sutures. Primary outcome was surgical site infection (SSI). Secondary outcomes were prosthetic joint infection (PJI), other wound complications (dehiscence, necrosis and prolonged drainage) and duration of admittance. Follow-up occurred at 2, 6, and 12 weeks, and at 1 year.

RESULTS

There were no significant demographic differences between the 2 groups. SSI occurred more frequently when wounds were closed with staples (4% compared to 1% with sutures; OR 2.8; CI, 0.885-0.952;  = 0.057). SSI was treated with oral antibiotics. The staples group showed significantly more wound complications (17% compared to 5%; OR 3.943, CI 2.073-7.498;  = 0.000). Wound discharge was significantly prolonged in the staples group ( = 40, compared to  = 12 in the sutures group; OR 3.728; CI, 1.909-7.281;  = 0.000). There was no significant difference in PJI ( = 0.364).

CONCLUSIONS

In this large RCT comparing staples with sutures after THA, the use of staples is associated with a nearly 3 times greater risk of SSI (OR 2.8;  = 0.057). Staples significantly prolong wound discharge. The use of sutures for wound closure after THA is advised. Staples Or Sutures trial (S.O.S. trial) http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3946, NTR3946.

摘要

目的

在接受初次全髋关节置换术(THA)的患者中,使用吻合钉或缝线进行伤口缝合,其手术部位感染率是否更低?

设计

前瞻性随机对照多中心试验。

方法

纳入535例行THA的患者并随机分为两组:268例伤口用吻合钉缝合,267例用缝线缝合。主要结局为手术部位感染(SSI)。次要结局为人工关节感染(PJI)、其他伤口并发症(裂开、坏死和引流时间延长)及住院时间。在2周、6周、12周和1年时进行随访。

结果

两组间人口统计学特征无显著差异。用吻合钉缝合伤口时SSI发生率更高(4%,而缝线缝合为1%;OR 2.8;CI,0.885 - 0.952;P = 0.057)。SSI采用口服抗生素治疗。吻合钉组伤口并发症显著更多(17%,而缝线缝合组为5%;OR 3.943,CI 2.073 - 7.498;P = 0.000)。吻合钉组伤口引流时间显著延长(吻合钉组为40天,而缝线缝合组为12天;OR 3.728;CI,1.909 - 7.281;P = 0.000)。PJI无显著差异(P = 0.364)。

结论

在这项比较THA后使用吻合钉与缝线的大型随机对照试验中,使用吻合钉发生SSI的风险几乎高3倍(OR 2.8;P = 0.057)。吻合钉显著延长伤口引流时间。建议THA后使用缝线进行伤口缝合。吻合钉或缝线试验(S.O.S.试验)http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3946,NTR3946 。

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