Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.
Institute for Medical Statistics, Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.
Int Wound J. 2023 Apr;20(4):925-934. doi: 10.1111/iwj.13939. Epub 2022 Nov 29.
Postoperative wound-site bleeding, tissue inflammation and seroma formation are well-known complications in the field of breast surgery. Hemostatic agents consisting of polysaccharides may be used intra-operatively to minimise postoperative complications. We conducted a prospective randomised-controlled, single-centre study including 136 patients undergoing breast-conserving surgery for invasive or intraductal breast cancer. Of these, 68 patients were randomised to receive an absorbable polysaccharide hemostatic agent into the wound site during surgery, while 68 patients were randomised to the control group and did not receive any hemostatic agent. Primary outcome was the total volume of postoperative drained fluid from the surgical site. Secondary outcomes were the number of days until drain removal and rate of immediate postoperative surgical site infection Patients in the intervention group had significantly higher drainage output volumes compared with the control group 85 mL (IQR 46.25-110) versus 50 mL (IQR 30-75), respectively; (P = .003). Univariable linear regression analyses showed a significant association between the surgical specimen and the primary outcome (P < .001). After multivariable analysis, the use of absorbable polysaccharide hemostatic product was no longer significantly associated with a higher drainage output and only the size of the surgical specimen remained a significant predictor. The number of days until drainage removal and the postoperative seroma formation were higher in the intervention group (P = .004) and (P = .003), respectively. In our study, intraoperative application of polysaccharide hemostatic agent during breast-conserving surgery did not decrease postoperative fluid production. Only the size of the surgical specimen was significantly associated with postoperative drainage volume.
术后伤口部位出血、组织炎症和血清肿形成是乳腺外科领域众所周知的并发症。含有多糖的止血剂可在手术中使用,以尽量减少术后并发症。我们进行了一项前瞻性随机对照、单中心研究,纳入了 136 名接受保乳手术治疗浸润性或导管内乳腺癌的患者。其中,68 名患者被随机分配在手术中于伤口部位使用可吸收多糖止血剂,而 68 名患者被随机分配至对照组,不使用任何止血剂。主要结局是手术部位术后引流的总液体量。次要结局是引流管拔除的天数和即时术后手术部位感染的发生率。干预组患者的引流量明显高于对照组,分别为 85ml(IQR 46.25-110)和 50ml(IQR 30-75)(P=0.003)。单变量线性回归分析显示,手术标本与主要结局之间存在显著关联(P<0.001)。多变量分析后,可吸收多糖止血产品的使用与更高的引流量之间不再显著相关,只有手术标本的大小仍然是一个显著的预测因素。干预组患者的引流管拔除天数和术后血清肿形成的发生率更高(P=0.004)和(P=0.003)。在我们的研究中,保乳手术中术中应用多糖止血剂并没有减少术后液体生成。只有手术标本的大小与术后引流量显著相关。