Liu Yuan-Fu, Hsu Yu-Chia, Chen Po-Lin, Chuang Hao-Jun, Tu Ting-Yuan, Chang Chao-Jui, Hsiao Yu-Meng, Lin Cheng-Li
Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan; Department of Orthopedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Department of Orthopedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Spine J. 2025 May 5. doi: 10.1016/j.spinee.2025.05.002.
Surgical site infections (SSIs) are a significant complication in spine surgery, particularly in instrumented procedures, leading to increased morbidity and healthcare costs. Despite standard preoperative disinfection protocols, bacterial contamination remains prevalent. Strategies such as intraoperative antiseptic irrigation have been explored to mitigate contamination, yet the comparative efficacy of different antiseptic solutions remains unclear.
This study aimed to evaluate the effectiveness of intraoperative antiseptic solution soaking with normal saline (NS), povidone-iodine (PVP-I), and chlorhexidine gluconate (CHG) in reducing bacterial contamination in lumbar instrumented fusion surgery.
STUDY DESIGN/SETTING: A single-center, single-blinded, randomized controlled trial was conducted at a tertiary medical center in Taiwan.
A total of 105 patients undergoing posterior lumbar interbody fusion surgery were enrolled and randomly assigned to three groups: NS (n=35), PVP-I (n=35), or CHG (n=35). Patients with prior lumbar procedures, known allergies to antiseptics, previous spinal infections, trauma, or tumors were excluded.
The primary outcome was the reduction in bacterial contamination, assessed via intraoperative cultures from three sites-superficial tissues, deep tissues, and implant surfaces-before and after antiseptic irrigation. Secondary outcomes included the incidence of postoperative SSIs and clinical complications over a 6-month follow-up period.
Patients were randomized into three groups, each receiving a 3-minute soak with the assigned antiseptic solution before wound closure, followed by normal saline irrigation. Swab samples were collected pre- and postirrigation for bacterial culture and 16S rRNA PCR analysis. Statistical analysis was performed using logistic regression and Bonferroni correction for multiple comparisons.
Among 105 patients, preirrigation bacterial culture positivity rates were 49.5% in superficial tissues, 31.4% in deep tissues, and 32.4% on implants. Postirrigation, NS showed no significant bacterial reduction, while PVP-I reduced superficial contamination (55.0%, p=.015) but no significant effect in deeper tissues and implants. CHG showed the greatest bacterial reduction, significantly outperforming NS (OR: 0.06, 95% CI: 0.01-0.54, p=.011) and PVP-I (OR: 0.06, 95% CI: 0.01-0.56, p=.012) on implant surfaces. Despite these differences in culture rate, SSI rates remained low and comparable among groups (p=.72), with no reported antiseptic-related complications.
This study confirms that bacterial contamination remains high despite standard preoperative disinfection in lumbar fusion surgery. Among the tested antiseptic solutions, CHG demonstrated superior efficacy in reducing bacterial residues, particularly on implant surfaces. These findings support CHG as a promising antiseptic for intraoperative irrigation in spine surgery. Further multi-center studies are needed to validate its impact on reducing SSIs and improving long-term outcomes.
Level II.
手术部位感染(SSIs)是脊柱手术中的一种重要并发症,尤其是在使用内固定器械的手术中,会导致发病率增加和医疗成本上升。尽管有标准的术前消毒方案,但细菌污染仍然普遍存在。人们已经探索了术中抗菌冲洗等策略来减轻污染,但不同抗菌溶液的相对疗效仍不明确。
本研究旨在评估术中用生理盐水(NS)、聚维酮碘(PVP-I)和葡萄糖酸氯己定(CHG)浸泡抗菌溶液在减少腰椎内固定融合手术中细菌污染方面的有效性。
研究设计/地点:在台湾的一家三级医疗中心进行了一项单中心、单盲、随机对照试验。
共有105例行后路腰椎椎间融合手术的患者入组并随机分为三组:NS组(n = 35)、PVP-I组(n = 35)或CHG组(n = 35)。排除既往有腰椎手术史、已知对抗菌剂过敏、既往有脊柱感染、创伤或肿瘤的患者。
主要观察指标是通过术中在抗菌冲洗前后从三个部位——浅表组织、深部组织和植入物表面——进行培养来评估细菌污染的减少情况。次要观察指标包括术后6个月随访期内手术部位感染的发生率和临床并发症。
患者被随机分为三组,每组在伤口闭合前用指定的抗菌溶液浸泡3分钟,然后用生理盐水冲洗。在冲洗前后采集拭子样本进行细菌培养和16S rRNA PCR分析。采用逻辑回归和Bonferroni校正进行多重比较的统计分析。
在105例患者中,冲洗前浅表组织细菌培养阳性率为49.5%,深部组织为31.4%,植入物表面为32.4%。冲洗后,NS组细菌减少不显著,而PVP-I组减少了浅表污染(55.0%,p = 0.015),但对深部组织和植入物无显著影响。CHG组细菌减少最多,在植入物表面显著优于NS组(OR:0.06,95%CI:0.01 - 0.54,p = 0.011)和PVP-I组(OR:0.06,95%CI:0.01 - 0.56,p = 0.012)。尽管培养率存在这些差异,但手术部位感染率仍然较低且各组之间相当(p = 0.72),未报告与抗菌剂相关的并发症。
本研究证实,尽管腰椎融合手术术前进行了标准消毒,但细菌污染仍然很高。在所测试的抗菌溶液中,CHG在减少细菌残留方面表现出卓越的效果,尤其是在植入物表面。这些发现支持CHG作为脊柱手术术中冲洗的一种有前景的抗菌剂。需要进一步的多中心研究来验证其对减少手术部位感染和改善长期结局的影响。
二级。