次氯酸消毒剂在骨科术后切口愈合中的应用:一项实效性随机对照试验
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Application of hypochlorous acid disinfectant in postoperative wound healing of orthopedic surgery: a pragmatic randomized controlled trial
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    摘要:

    目的 探讨次氯酸应用于外科术后切口愈合及减少术后切口感染的临床效果。方法 纳入某三级甲等医院足踝外科住院患者,按手术时序进行分组:第一阶段(2024年10月16日—12月16日)为对照组,采用 4 500~5 500 mg/L碘伏消毒术后切口;第二阶段(2024年12月17日—2025年2月17日)为试验组,采用(110±16.5) mg/L 次氯酸消毒术后切口。术后第1、3、5、7、10、14天进行切口消毒、指标评价并记录。主要结局指标为手术部位感染,次要指标包括术后48 h红肿、过敏及疼痛程度评分。结果 对照组感染发病率为0.96%,术后48 h红肿发生率为16.99%,疼痛评分(1.41±0.49)分;试验组未发生感染,术后48 h红肿发生率为9.58%,疼痛评分为(1.36±0.48)分。两组感染发病率及疼痛评分差异均无统计学意义(均P>0.05),红肿发生率差异具有统计学意义(P=0.006)。按切口类型进行分层分析显示,开放性外伤亚组中,对照组感染发病率为3.19%,红肿发生率为 29.79%,疼痛评分为(1.62±0.49)分;试验组术后48 h红肿发生率为8.14%,疼痛评分为(1.41±0.49)分,两组感染发病率差异无统计学意义(P>0.05),红肿发生率(P<0.001)及疼痛程度评分(P=0.005)差异均有统计学意义。闭合性外伤亚组中,各结局指标组间比较差异均无统计学意义(均P>0.05)。结论 次氯酸溶液在闭合性外伤术后切口应用的效果与碘伏相当;在开放性外伤术后应用中,其控制术后红肿发生及疼痛的效果优于碘伏。

    Abstract:

    Objective To explore the clinical efficacy of hypochlorous acid in promoting postoperative wound hea-ling and reducing surgical site infection (SSI). Methods Hospitalized patients from the Department of Foot and Ankle Surgery in a tertiary first-class hospital were included in the analysis and grouped according to surgery sequence: patients from the first stage (October 16 to December 16, 2024) were taken as the control group, and iodophor (4 500-5 500 mg/L) was used for their postoperative wound disinfection; patients from the second stage (December 17, 2024 to February 17, 2025) were taken as the trial group, whose surgical wounds were disinfected with hypochlorous acid (110±16.5 mg/L). On the 1st, 3rd, 5th, 7th, 10th, and 14th days post-operation, wounds were disinfected, indicators were evaluated and recorded. The main outcome indicator was surgical site infection, while secondary indicators included postoperative 48-hour redness and swelling, allergy, and pain severity scores. Results The control group showed an infection incidence of 0.96%, an incidence of postoperative 48-hour redness and swelling of 16.99%, and a pain score of (1.41±0.49) point. In the trial group, no infections occurred, the incidence of postoperative 48-hour redness and swelling was 9.58%, and the pain score was (1.36±0.48) point. There were no statistically significant differences in the incidence of infection and pain score between the two groups (both P>0.05), but the difference in the incidence of redness and swelling was statistically significant (P=0.006). Stratified analysis by wound types revealed that in the open trauma subgroup, the incidence of infection in the control group was 3.19%, the incidence of redness and swelling was 29.79%, and the pain score was (1.62±0.49) point; while the incidence of postoperative 48-hour redness and swelling in the trial group was 8.14%, with a pain score of (1.41±0.49) point. There was no statistically significant difference in the incidence of infection between the two groups (P>0.05), while differences in the incidences of redness and swelling (P<0.001) as well as pain severity score (P=0.005) were statistically significant. In the closed traumatic injury subgroup, there were no statistically significant differences in all outcome indicators between groups (all P>0.05). Conclusion The application efficacy of hypochlorous acid solution in wound healing after closed traumatic injuries is comparable to that of iodophor. In open traumatic injuries, hypochlorous acid demonstrates superior effectiveness in controlling postoperative redness and swelling as well as pain compared to iodophor.

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张燕,朱迪,孙磊,等.次氯酸消毒剂在骨科术后切口愈合中的应用:一项实效性随机对照试验[J]. 中国感染控制杂志,2025,24(12):1803-1809. DOI:10.12138/j. issn.1671-9638.20252751.
ZHANG Yan, ZHU Di, SUN Lei, et al. Application of hypochlorous acid disinfectant in postoperative wound healing of orthopedic surgery: a pragmatic randomized controlled trial[J]. Chin J Infect Control, 2025,24(12):1803-1809. DOI:10.12138/j. issn.1671-9638.20252751.

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  • 收稿日期:2025-07-14
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  • 在线发布日期: 2025-12-31
  • 出版日期: 2025-12-28