Topical tranexamic acid in mastectomies on haematoma formation: prospective cohort study

BACKGROUND: Reports suggest tranexamic acid (TXA) reduces haematoma formation after breast surgery. This study investigated the effects of postoperative retrograde instillation of topical TXA through surgical drains on postoperative haematoma formation requiring surgical intervention and drain output 24 hours after mastectomy procedures.

METHODS: A prospective cohort study was conducted from October 2020 until September 2023, comprising two consecutive periods. In the first period, women underwent mastectomy without receiving TXA (control); in the second, women received retrograde instillation of 20 ml of 50 mg/ml TXA into the drain immediately after cavity closure. This was performed as part of a change in routine practice in April 2023. Primary endpoints collected from patient medical records were haematoma formation requiring surgical intervention, mean drain output 24 hours after the procedure, and thromboembolic events. Type of surgery, age, body mass index, smoking status, the use of blood thinners, neoadjuvant therapy, and the indication for surgery were considered patient variables that could potentially affect primary endpoints. Regression analysis was used to analyse relationships between TXA administration and haematoma occurrence and drain output, adjusting for the specified patient variables. This study was designed in accordance with STROBE guidelines.

RESULTS: Among 297 breasts (271 women) receiving topical TXA and 278 breasts (264 women) in the control group, 4 (1%) and 19 (7%) breasts, respectively, had surgical revisions due to haematoma (P = 0.003). Drain output within the first 24 hours after the procedure was significantly lower in the TXA than control group (mean(standard deviation) 67.6(62.4) versus 103.9(106.6) ml, respectively; P < 0.001). No thromboembolic events were reported. Women in the control group had a higher body mass index and mean age, and a higher proportion underwent axillary clearance and received neoadjuvant therapy compared with the TXA group. A higher proportion of women in the TXA group underwent sentinel node biopsy. After adjusting for these variables, significant differences remained between the two groups in haematoma rate (P = 0.005) and drain output (P = 0.001).

CONCLUSION: Retrograde administration of 20 ml of 50 mg/ml topical TXA into the cavity after mastectomy significantly reduced the incidence of haematoma formation and drain output within the first 24 hours.