Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial

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.

Development of Experimental Animal Model and Methodology for Evaluation of a Seroma Prevention Approach

“…NBCAs are now used not only for external use but also for various indications such as hernia mesh fixation [49], bone adhesion [50], arterial embolization [51,52] or ablation of varicose veins [53]. As for seroma prevention, NBCAs appear to be effective without significant toxicity according to some recent studies [54,55]. In our case, VENASEAL ® was very effective in significantly preventing seroma production, but appeared to be prone to inflammatory reactions over the entire surface of the skin flap, despite being applied in very small quantities and in a dispersed manner.…”

Efficacy of perioperative systemic tranexamic acid along with topical hemocoagulase in decreasing axillary drain output in breast cancer patients undergoing axillary lymph node dissection: A randomized, double‐blind, placebo‐controlled, superiority trial

“…No consensus exists on the single best method to reduce the amount and duration of drainage consistently and reliably. 1 Closure of axillary space with suction drains remains the conventional method after ALND. 2 However, suction drains act as a foreign body creating a certain degree of discomfort, requiring regular maintenance, and limiting physical activity.…”

“…This can delay wound healing, cause skin flap necrosis, may lead to wound infection, prolong the hospital stay/lead to frequent outpatient visits, and delay adjuvant therapies. No consensus exists on the single best method to reduce the amount and duration of drainage consistently and reliably 1 . Closure of axillary space with suction drains remains the conventional method after ALND 2 .…”