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PräVAC 试验的最终结果:采用表皮负压辅助伤口闭合技术预防阴茎癌患者腹股沟淋巴结清扫术后的伤口并发症。

Final results of the PräVAC trial: prevention of wound complications following inguinal lymph node dissection in patients with penile cancer using epidermal vacuum-assisted wound closure.

机构信息

Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Ismaningerstr. 22, 81375, Munich, Germany.

Department of Urology, Universitätsklinikum Würzburg, Würzburg, Germany.

出版信息

World J Urol. 2021 Feb;39(2):613-620. doi: 10.1007/s00345-020-03221-z. Epub 2020 May 5.

DOI:10.1007/s00345-020-03221-z
PMID:32372159
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7910363/
Abstract

PURPOSE

Inguinal lymphadenectomy in penile cancer is associated with a high rate of wound complications. The aim of this trial was to prospectively analyze the effect of an epidermal vacuum wound dressing on lymphorrhea, complications and reintervention in patients with inguinal lymphadenectomy for penile cancer.

PATIENTS AND METHODS

Prospective, multicenter, randomized, investigator-initiated study in two German university hospitals (2013-2017). Thirty-one patients with penile cancer and indication for bilateral inguinal lymph node dissection were included and randomized to conventional wound care on one side (CONV) versus epidermal vacuum wound dressing (VAC) on the other side.

RESULTS

A smaller cumulative drainage fluid volume until day 14 (CDF) compared to contralateral side was observed in 15 patients (CONV) vs. 16 patients (VAC), with a median CDF 230 ml (CONV) vs. 415 ml (VAC) and a median maximum daily fluid volume (MDFV) of 80 ml (CONV) vs. 110 ml (VAC). Median time of indwelling drainage: 7 days (CONV) vs. 8 days (VAC). All grade surgery-related complications were seen in 74% patients (CONV) vs. 74% patients (VAC); grade 3 complications in 3 patients (CONV) vs. 6 patients (VAC). Prolonged hospital stay occurred in 32% patients (CONV) vs. 48% patients (VAC); median hospital stay was 11.5 days. Reintervention due to complications occurred in 45% patients (CONV) vs. 42% patients (VAC).

CONCLUSIONS

In this prospective, randomized trial we could not observe a significant difference between epidermal vacuum treatment and conventional wound care.

摘要

目的

阴茎癌的腹股沟淋巴结清扫术会导致很高的伤口并发症发生率。本试验旨在前瞻性分析表皮负压伤口敷贴对阴茎癌腹股沟淋巴结清扫术患者淋巴液漏、并发症和再次干预的影响。

患者和方法

这是一项在两家德国大学医院进行的前瞻性、多中心、随机、研究者发起的研究(2013-2017 年)。纳入 31 例有阴茎癌且需要双侧腹股沟淋巴结清扫术的患者,并随机分为一侧采用常规伤口护理(CONV),另一侧采用表皮负压伤口敷贴(VAC)。

结果

15 例患者(CONV)与 16 例患者(VAC)相比,在第 14 天前的累积引流液量(CDF)较小,中位数 CDF 为 230ml(CONV)比 415ml(VAC),中位数最大日流量(MDFV)为 80ml(CONV)比 110ml(VAC)。留置引流时间中位数:7 天(CONV)比 8 天(VAC)。74%的患者(CONV)和 74%的患者(VAC)发生了所有分级手术相关并发症;3 例患者(CONV)和 6 例患者(VAC)发生了 3 级并发症。32%的患者(CONV)和 48%的患者(VAC)需要延长住院时间;中位住院时间为 11.5 天。由于并发症而需要再次干预的患者比例为 45%(CONV)和 42%(VAC)。

结论

在这项前瞻性、随机试验中,我们未观察到表皮负压治疗与常规伤口护理之间存在显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/483f/7910363/74d1bad1c554/345_2020_3221_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/483f/7910363/4af5fb837764/345_2020_3221_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/483f/7910363/f9fb9d45b3ff/345_2020_3221_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/483f/7910363/33efff91d28a/345_2020_3221_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/483f/7910363/74d1bad1c554/345_2020_3221_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/483f/7910363/4af5fb837764/345_2020_3221_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/483f/7910363/f9fb9d45b3ff/345_2020_3221_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/483f/7910363/33efff91d28a/345_2020_3221_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/483f/7910363/74d1bad1c554/345_2020_3221_Fig4_HTML.jpg

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本文引用的文献

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Adherence to the EAU guideline recommendations for systemic chemotherapy in penile cancer: results of the E-PROPS study group survey.遵循 EAU 指南推荐的阴茎癌全身化疗:E-PROPS 研究组调查结果。
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Organ-sparing surgery of penile cancer: higher rate of local recurrence yet no impact on overall survival.阴茎癌的保器官手术:局部复发率较高,但对总体生存率无影响。
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Adherence to EAU guidelines on penile cancer translates into better outcomes: a multicenter international study.
负压伤口治疗用于通过一期缝合愈合的手术伤口。
Cochrane Database Syst Rev. 2020 Jun 15;6(6):CD009261. doi: 10.1002/14651858.CD009261.pub6.
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