局部硬化剂对乳房切除术后血清瘤最小化的评价:一项安慰剂对照、双盲、随机试验。

Ashraf Khater, Ahmed Hassan, Omar Farouk, Ahmed Sinbel, Saleh Saleh, Mahmoud Abdelaziz, Osama Eldamshety
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引用次数: 0

摘要

目的:乳房切除术后血清肿是一个困扰患者的问题。局部硬化剂是减少血肿的一种方法。本研究的目的是评估在乳房全切除术后用强力霉素或博来霉素封闭前喷洒皮瓣是否可以预防血清肿。材料和方法:经机构审查委员会批准,采用计算机随机化程序,于2017年8月1日至2018年8月1日进行前瞻性、双盲、安慰剂对照的随机优势研究。IRB提案代码为MS/17.08.66,试验于2017年8月15日获得批准。该试验可在http://www.eulc.edu.eg/eulc_v5/Libraries/Thesis/BrowseThesisPages.aspx?fn=PublicDrawThesis&BibID=12553049上公开获取。该研究的主要结果是评估全乳切除术后血清肿的发生率,干预包括用多西环素或博来霉素喷洒皮瓣与安慰剂。选择全乳切除术的患者随机分为对照组、强力霉素组和博来霉素组。术后数据包括住院时间、三组疼痛评分、术后引流液量、术后引流天数、感染、皮瓣坏死、血肿等并发症发生率、血肿发生率、抽吸血肿量、术后总就诊次数。结果:125例患者中,90例适合全乳切除术。对这90例的分析表明,血清肿的发生率相似;对照组、强力霉素组和博来霉素组分别为43.4%、40%和40% (p = 0.99)。此外,所有组的伤口并发症发生率相似。结论:尽管对危险因素的认识和管理有所改善,血清瘤仍然是全乳切除术后临床常见的问题。这些结果表明,硬化剂,特别是博来霉素和强力霉素,对预防乳房切除术后血清肿没有作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of Topical Sclerosant Agents for Minimization of Postmastectomy Seroma: A Placebo-Controlled, Double-Blind, Randomized Trial.

Objective: Seroma after mastectomy is a bothersome problem. Topical sclerosants are one method used to reduce seroma. The aim of this study was to evaluate if spraying flaps before closure with doxycycline or bleomycin after total mastectomy can prevent seroma.

Materials and methods: After institutional review board approval, using a computer-based randomization program, a prospective, double-blind, placebo-controlled randomized, superiority study was conducted during the period from the first of August 2017 to the first of August 2018. IRB proposal code was MS/17.08.66 and the trial was approved at 15/8/2017. The trial is available publicly at http://www.eulc.edu.eg/eulc_v5/Libraries/Thesis/BrowseThesisPages.aspx?fn=PublicDrawThesis&BibID=12553049. The primary outcome of the study was to assess the incidence of seroma following total mastectomy after intervention comprising spraying of skin flaps with doxycycline or bleomycin versus placebo. Patients who were candidates for total mastectomy were randomized into control, doxycycline, and bleomycin groups. The postoperative data included length of the hospital stay, pain score among the three groups, post-operative drained fluid volume, post-operative day of drain removal, complication rates including infection, flap necrosis and hematoma, the incidence of seroma and aspirated seroma volume, and total number of postoperative visits.

Results: Of 125 patients, 90 were candidates for total mastectomy. Analysis of these 90 showed that the incidence of seroma was similar; 43.4%, 40% and 40% in the control, doxycycline, and bleomycin groups, respectively (p = 0.99). Furthermore, wound complication rates were similar among all groups.

Conclusion: Despite improved recognition and management of risk factors, seromas remain a common clinical concern in the postoperative setting of total mastectomy. These results suggest that sclerosant agents, specifically bleomycin and doxycycline, have no utility for prevention of post mastectomy seroma.

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