Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial

Background Topical administration of tranexamic acid (TXA) may be an alternative to intravenous administration to reduce bleeding with a lower risk of systemic adverse events. The aim of this study was to investigate whether moistening a surgical wound with TXA before closure, leaving a thin film of drug only, would reduce postoperative bleeding. Methods This was a two-centre, stratified, parallel-group, placebo-controlled, double-blind RCT. Patients undergoing mastectomy with or without axillary lymph node clearance were randomized 1 : 1 to moistening of wound surface before closure with either 25 mg/ml TXA or 0 center dot 9 per cent sodium chloride (placebo). The primary endpoint was postoperative bleeding as measured by drain production in the first 24 h. Secondary endpoints were early haematoma, total drain production, postoperative complications and late aspirations of seroma within 3 months. Results Between 1 January 2016 and 31 August 2018, 208 patients were randomized. Two patients were converted to a different surgical procedure at surgery, and four did not receive the intervention owing to technical error. Thus, 202 patients were included in the study (101 in the TXA and 101 in the placebo group). TXA reduced mean drain production at 24 h (110 versus 144 ml; mean difference 34 (95 per cent c.i. 8 to 60) ml, P = 0 center dot 011). One patient in the TXA group had early haematoma compared with seven in the placebo group (odds ratio (OR) 0 center dot 13 (95 per cent c.i. 0 center dot 02 to 1 center dot 07); P = 0 center dot 057). There was no significant difference in postoperative complications between TXA and placebo (13 versus 10; OR 1 center dot 11 (0 center dot 45 to 2 center dot 73), P = 0 center dot 824) or need for late seroma aspirations (79 versus 67 per cent; OR 1 center dot 83 (0 center dot 91 to 3 center dot 68), P = 0 center dot 089). Conclusion Moistening the wound with TXA 25 mg/ml before closure reduces postoperative bleeding within the first 24 h in patients undergoing mastectomy. Registration number: NCT02627560 ().