The effect of intrawound vancomycin powder on surgical site infection in inguinal lymph node dissection: a randomized controlled trial pilot study

IF 1.2 Q3 OBSTETRICS & GYNECOLOGY

Gynecologic Oncology Reports Pub Date : 2025-05-09 DOI:10.1016/j.gore.2025.101765

Jessica B. DiSilvestro , Emily Zitek , Katina Robison , Jasmine Ebott , Corinne Jansen , Katrin Eurich , Cara Mathews , Paul DiSilvestro , Matthew Oliver , Ashley Stuckey , Katherine Miller , Elizabeth Lokich

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引用次数: 0

Abstract

Background

Inguinal lymph node dissections are morbid surgeries with high rates of postoperative wound infections. The primary objective of this pilot study was to assess the feasibility of implementing a randomized controlled trial to assess the impact of intrawound vancomycin powder on postoperative complications after inguinal lymph node dissection in patients with vulvar cancer. Secondary objectives included 1) 30-day composite postoperative complication rate, and 2) adverse effects.

Methods

This was a single-site, unblinded randomized controlled trial. Patients with vulvar cancer planning to undergo an inguinal lymph node dissection were randomized 1:1 to receive intrawound vancomycin powder at the time of surgery versus standard of care without vancomycin powder. Descriptive statistics and Chi-square were utilized.

Results

Between October 2022 to May 2024, 31 patients met eligibility criteria and 30 patients enrolled (97 % recruitment rate). Three patients did not undergo surgery (90 % retention rate). All patients received their correctly assigned arm and all patients completed the postoperative follow-up (100 % adherence rate).

One patient in the vancomycin group had a composite postoperative complication (hematoma), while three patients in the control arm had a complication (three inguinal surgical site infections) [8 % vs. 21 %, p = 0.32]. There were no postoperative infections identified in the patients who received intrawound vancomycin powder. No adverse events occurred with the application of vancomycin.

Conclusion

This pilot study showed that this was a feasible trial with high recruitment, retention and adherence rates. The data supports proceeding with a larger trial to further elucidate the impact of this low-cost intervention.

Trial Registration: ClinicalTrials.gov Identifier: NCT05625373.

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万古霉素粉剂对腹股沟淋巴结清扫手术部位感染的影响：一项随机对照试验

腹股沟淋巴结清扫术是一种病态的手术，术后伤口感染的发生率很高。本初步研究的主要目的是评估实施一项随机对照试验的可行性，以评估万古霉素粉末对外阴癌患者腹股沟淋巴结清扫术后并发症的影响。次要目标包括：1)术后30天的综合并发症发生率；2)不良反应。方法采用单点、非盲随机对照试验。计划行腹股沟淋巴结清扫术的外阴癌患者被随机分为1:1组，分别在手术时接受万古霉素粉和不接受万古霉素粉的标准治疗。采用描述性统计和卡方分析。结果在2022年10月至2024年5月期间，31例患者符合入选标准，30例患者入组，招募率为97%。3例患者未行手术（保留率90%）。所有患者均接受了正确分配的手臂，所有患者均完成了术后随访（100%依从率）。万古霉素组1例患者出现复合术后并发症（血肿），对照组3例患者出现并发症（3例腹股沟手术部位感染）[8%比21%，p = 0.32]。术后使用万古霉素粉剂的患者无术后感染。应用万古霉素无不良事件发生。结论本初步研究表明，这是一项可行的试验，具有较高的招募率、保留率和依从率。这些数据支持进行更大规模的试验，以进一步阐明这种低成本干预措施的影响。试验注册：ClinicalTrials.gov标识符：NCT05625373。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Gynecologic Oncology Reports OBSTETRICS & GYNECOLOGY-

CiteScore

2.00

自引率

0.00%

发文量

183

审稿时长

41 days

期刊介绍： Gynecologic Oncology Reports is an online-only, open access journal devoted to the rapid publication of narrative review articles, survey articles, case reports, case series, letters to the editor regarding previously published manuscripts and other short communications in the field of gynecologic oncology. The journal will consider papers that concern tumors of the female reproductive tract, with originality, quality, and clarity the chief criteria of acceptance.