Axelsson Christen Kirk, Quamme Gro Maria, Lanng Charlotte, Szecsi Pal Bela, Mortensen Minea Brusgaard, Wegeberg Birgitte, Arpi Magnus, Lingskov Marianne, Puglich Mette Stub, Okholm Mette
Department F of Breast Surgery, Herlev Hospital, 2730 Herlev, Denmark.
Dan Med J. 2012 Sep;59(9):A4482.
This study served the following three purposes: To evaluate the prophylactic effect against seroma of a single dose of steroid in the mastectomy cavity, to evaluate the thesis that there is a connection between subclinical bacterial colonization and seroma formation and to evaluate if a simple urine stix test can detect postmastectomy infection.
This was a double-blinded and randomized study of injection of methylprednisolonacetate versus saline in the mastectomy cavity at the time of drain removal. A total of 160 females were enrolled after mastectomy. The study parameters were as follows: seroma volume, number of seroma punctures, frequency of clinical infections, degree and type of subclinical colonization, complications and evaluation of the microbiological results of the stix test with automatically read glucose, ketones, blood, pH, protein, nitrite and leucocytes. The degree of inflammation was monitored by measurement of 15 cytokines in each sample of seroma fluid. The study was initiated in August 2010 and is expected to run for three years.
Some reports have concluded that seroma formation forms part of postsurgical inflammation. Steroids are effective against inflammation and accumulation of fluid at the surgical site after several types of surgery and have also proved valuable in the treatment of seroma formation. In the present study, the prophylactic effect of steroids on seroma formation is investigated.
As the incidence of postmastectomy seroma formation is 80%, there is a need for improvement in the prophylaxis and treatment of this condition.
not relevant.
Medicines Agency The EudraCT number 2009-016650-40 has been issued for your Sponsor's Protocol Code Number 23837. Data protection agency J.no. F.750.75-2. The study is perfomed in collaboration with the GCP Unit, capital Region, Bispebjerg Hospital under the EudraCT number: 2009-016650-40.
本研究旨在实现以下三个目的：评估在乳房切除腔内单次注射类固醇对血清肿的预防效果；评估亚临床细菌定植与血清肿形成之间存在关联这一论点；评估简单的尿试纸检测能否检测出乳房切除术后感染。
这是一项双盲随机研究，在拔除引流管时于乳房切除腔内注射醋酸甲泼尼龙与生理盐水。共有160名女性在乳房切除术后入组。研究参数如下：血清肿体积、血清肿穿刺次数、临床感染频率、亚临床定植的程度和类型、并发症以及对试纸检测微生物结果的评估（自动读取葡萄糖、酮体、血液、pH值、蛋白质、亚硝酸盐和白细胞）。通过测量每份血清肿液样本中的15种细胞因子来监测炎症程度。该研究于2010年8月启动，预计持续三年。
一些报告得出结论，血清肿形成是术后炎症的一部分。类固醇对多种手术后手术部位的炎症和液体蓄积有效，并且在治疗血清肿形成方面也已证明具有价值。在本研究中，对类固醇对血清肿形成的预防效果进行了研究。
由于乳房切除术后血清肿形成的发生率为80%，因此需要改进对此病症的预防和治疗。
无关。
药品管理局已为您的申办者方案代码23837分配了欧盟临床试验编号2009 - 016650 - 40。数据保护机构编号：F.750.75 - 2。该研究是与首都地区比斯佩比约格医院的药物临床试验质量管理规范（GCP）部门合作进行的，欧盟临床试验编号为：2009 - 016650 - 40。
