The Effect of Low and High Vacuum Drainage on the Postoperative Drainage of Breast Cancer: Insights from a Prospective, Non-Inferiority, Randomized Clinical Trial

摘要

Background:Vacuum drains have been extensively applied to prevent seroma formation after breast surgery. However, the usage of negative suction drainage is mainly determined by surgeon's experience and preferences. The aim of this study is to prospectively compare the drain effect after breast surgery between the low and high vacuum drains.Methods:This prospectively randomized trial (from January 2018 to June 2019) involved 188 patients who were subjected to modified radical mastectomy (group A, n=128) or immediate breast reconstruction with implants (group B, n=60). In each group, patients were randomized to receive high vacuum drain (pressure=-98 kPa) or low vacuum drain (pressure=-12 kPa) after surgery. Days of drain permanence, which means the duration of drainage, was the primary endpoint.Results:According to the comparison of days of drain permanence, the effect of a low vacuum drain is not inferior to a high vacuum drain in group A (pectoral drain, P0.001; axillary drain, P0.001) or group B (submuscular drain, P=0.002). The complications frequently occurred on patients with high vacuum drain (11.7%), such as seroma formation. The expense of low vacuum drain was significantly lower than high vacuum drain in both groups (P0.01).Conclusion:The drain effect of the low vacuum drain is not inferior to a high vacuum drain in both group A and group B. The low vacuum drain was effective, relatively cheap, and did not increase the incidence of complications; it is therefore more recommended after breast surgery.? 2020 Lin et al.