Al-Masri Mahmoud, Alawneh Fade, Daoud Faiez, Ebous Ali, Hamdan Basem, Al-Najjar Hani, Al-Masri Rama, Abufara Marwan
Department of Surgery, King Hussein Cancer Center, Amman, Jordan.
School of Medicine, University of Jordan, Amman, Jordan.
Front Oncol. 2021 Jan 25;10:580861. doi: 10.3389/fonc.2020.580861. eCollection 2020.
BACKGROUND/PURPOSE: Seroma is a common complication after axillary dissection in women with node-positive breast cancer. We aim to determine the effect of Cyanoacrylate on reducing seroma formation in patients undergoing axillary dissection. This a randomized clinical trial.
This is a single-center, randomized, single-blinded, and two-arm parallel study. Women with node-positive breast cancer eligible for axillary dissection were enrolled. Patients with a Body Mass Index (BMI) greater than 35 kg/m, those who underwent immediate breast reconstruction, and/or received neoadjuvant chemotherapy were excluded. Patients were randomized in a 1:1 ratio, and were stratified according to their age, BMI, tumor size, and operation type. The primary endpoint was the total seroma volume (the total drained volume and the total aspirated volume after drain removal). Data presented as mean and range when applicable.
111 patients were randomized (Cyanoacrylate 57; control 54). 105 patients were analyzed. Sixty-nine patients underwent breast conserving surgery, and 36 underwent modified radical mastectomy. There was no difference in the total seroma volume between the Cyanoacrylate vs. control arms (1,304 (60-4,950) vs. 1,446 (100-5,223) ml, =0.458). Wound infection, flap necrosis, number of manual aspirates, and hematoma formation were not statistically different between the two groups. Time to drain removal was shorter in the Cyanoacrylate arm (11.04(3-23) vs. 13.84(3-37) days, =0.015). The use of Cyanoacrylate was not cost effective ($586.93 (550-748) vs. $29.63 (0-198), <0.001). Higher seroma volume was correlated with modified radical mastectomy, older age, and BMI more than 30 kg/m.
Cyanoacrylate did not reduce seroma formation and its use was not cost effective.
clinicaltrials.gov, identifier NCT02141373.
背景/目的：血清肿是淋巴结阳性乳腺癌女性患者腋窝清扫术后的常见并发症。我们旨在确定氰基丙烯酸酯对减少接受腋窝清扫术患者血清肿形成的效果。这是一项随机临床试验。
这是一项单中心、随机、单盲、双臂平行研究。纳入符合腋窝清扫术条件的淋巴结阳性乳腺癌女性患者。排除体重指数（BMI）大于35kg/m²、接受即刻乳房重建和/或接受新辅助化疗的患者。患者按1:1比例随机分组，并根据年龄、BMI、肿瘤大小和手术类型进行分层。主要终点是血清肿总体积（引流总量和拔除引流管后抽吸总量）。数据在适用时以均值和范围表示。
111例患者被随机分组（氰基丙烯酸酯组57例；对照组54例）。对105例患者进行了分析。69例患者接受了保乳手术，36例接受了改良根治性乳房切除术。氰基丙烯酸酯组与对照组之间的血清肿总体积无差异（1304（60 - 4950）ml对1446（100 - 5223）ml，P = 0.458）。两组之间伤口感染、皮瓣坏死、手动抽吸次数和血肿形成在统计学上无差异。氰基丙烯酸酯组拔除引流管的时间更短（11.04（3 - 23）天对13.84（3 - 37）天，P = 0.015）。使用氰基丙烯酸酯不具有成本效益（586.93（550 - 748）美元对29.63（0 - 198）美元，P < 0.001）。更高的血清肿体积与改良根治性乳房切除术、年龄较大和BMI大于30kg/m²相关。
氰基丙烯酸酯并未减少血清肿形成，且其使用不具有成本效益。
clinicaltrials.gov，标识符NCT02141373。
