Burak W E, Goodman P S, Young D C, Farrar W B
Department of Surgery, Arthur G. James Cancer Hospital and Research Institute, Ohio State University College of Medicine, Columbus, USA.
J Surg Oncol. 1997 Jan;64(1):27-31. doi: 10.1002/(sici)1096-9098(199701)64:1<27::aid-jso6>3.0.co;2-r.
Seromas of the axillary space following breast surgery can lead to significant morbidity and delay in the initiation of adjuvant therapy. A prospective, randomized study was undertaken to evaluate the effect of bovine spray thrombin on seroma formation following either modified radical mastectomy (MRM) or lumpectomy with axillary dissection (LAD). In addition, risk factors for seroma formation were analyzed and identified.
A total of 101 patients were randomized to receive either bovine thrombin (20,000 units) (treatment group) or no thrombin (control group) applied to their axilla following either MRM or LAD. Drains were left in place until the preceding 24-hour drainage was < 40 milliliters. The number of days the drains were in place and wound complications (including seroma formation) were recorded.
Forty-nine (n = 49) patients were assigned to the treatment gorup and 52 (n = 52) to the control group. MRM was performed on 60 patients (59%) and LAD oN 41 (41%). Eighteen of the 49 patients (37%) in the thrombin group developed a seroma in comparison to 21 of the 52 control patients (40%) (P = 0.71). Significant risk factors for seroma formation included increased age, patient weight, initial 72-hour wound drainage, and LAD. No statistically significant differences were observed between treatment and control groups with respect to time to drain removal, or the incidence of other wound complications.
Although thrombin by itself appears to have no effect on subsequent seroma development following axillary dissection, the identification of predictive variables will be helpful in designing future trials aimed at reducing the incidence of this common complication of breast surgery.
乳腺手术后腋窝间隙的血清肿可导致严重的发病率，并延迟辅助治疗的开始。进行了一项前瞻性随机研究，以评估牛喷雾凝血酶对改良根治性乳房切除术（MRM）或保乳手术加腋窝淋巴结清扫术（LAD）后血清肿形成的影响。此外，分析并确定了血清肿形成的危险因素。
总共101例患者被随机分为两组，在MRM或LAD后，一组在腋窝应用牛凝血酶（20,000单位）（治疗组），另一组不应用凝血酶（对照组）。引流管留置至前24小时引流量<40毫升。记录引流管留置天数和伤口并发症（包括血清肿形成）。
49例（n = 49）患者被分配到治疗组，52例（n = 52）患者被分配到对照组。60例（59%）患者接受了MRM，41例（41%）患者接受了LAD。凝血酶组49例患者中有18例（37%）发生血清肿，而对照组52例患者中有21例（40%）发生血清肿（P = 0.71）。血清肿形成的显著危险因素包括年龄增加、患者体重、最初72小时伤口引流量和LAD。治疗组和对照组在引流管拔除时间或其他伤口并发症发生率方面未观察到统计学显著差异。
尽管凝血酶本身似乎对腋窝淋巴结清扫术后血清肿的后续发展没有影响，但识别预测变量将有助于设计未来旨在降低这种常见乳腺手术并发症发生率的试验。
