Abstract
Background/PurposeSeroma 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.MethodsThis 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/m2, 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.Results111 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, p=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, p=0.015). The use of Cyanoacrylate was not cost effective ($586.93 (550–748) vs. $29.63 (0–198), p<0.001). Higher seroma volume was correlated with modified radical mastectomy, older age, and BMI more than 30 kg/m2.ConclusionCyanoacrylate did not reduce seroma formation and its use was not cost effective.Clinical Trial Registrationclinicaltrials.gov, identifier NCT02141373.
Highlights
Axillary dissection is still considered an essential procedure in the treatment of node positive breast cancer patients
Higher seroma volume was correlated with modified radical mastectomy, older age, and Body Mass Index (BMI) more than 30 kg/m2
The aim of this study is to investigate whether the use of Cyanoacrylate in axillary dissection reduces postoperative seroma formation
Summary
Axillary dissection is still considered an essential procedure in the treatment of node positive breast cancer patients. Seroma formation remains the most common complication after axillary dissection with reported incidence of 15%–90% [1,2,3,4,5,6]. Most seromas resolve within few weeks of surgery, seroma formation and its aspiration result in significant postoperative morbidity in terms of pain, discomfort, delayed wound healing, skin flap necrosis, and infection [7,8,9]. These complications may delay adjuvant treatment and affect patient recovery along with increased financial burden on health care system. No consensus exists despite numerous suggested strategies to reduce seroma formation including drains, buttress sutures, fibrin glue or patches, tetracycline sclerosing agents, methylprednisolone, somatostatin, and shoulder exercises [13, 15,16,17,18,19,20,21,22,23,24]
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