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

Abstract

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 0·9 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 = 0·011). One patient in the TXA group had early haematoma compared with seven in the placebo group (odds ratio (OR) 0·13 (95 per cent c.i. 0·02 to 1·07); P = 0·057). There was no significant difference in postoperative complications between TXA and placebo (13 versus 10; OR 1·11 (0·45 to 2·73), P = 0·824) or need for late seroma aspirations (79 versus 67 per cent; OR 1·83 (0·91 to 3·68), P = 0·089). 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 (https://clinicaltrials.gov).

Tranexamic acid in plastic surgery: routes of administration and dosage considerations

“…Notably, TXA was also found to be superior to steroids use in the prevention of bleeding [56]. Regarding studies on topical/local use of TXA, Ausen et al reported that topical application of TXA in mastectomy procedures was associated with a reduction in postoperative bleeding as measured by drain output in the first 24 h after surgery [49,58]. However, in the same study, the rate of seroma trended towards being higher in the TXA group, although not reaching statistical significance.…”

“…Tranexamic acid is the most popular anti-fibrinolytic used in aesthetic surgery [48]. In our review, 23 studies assessed the use of TXA in various aesthetic or breast-related procedures [48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63][64]. [57,59,60], and one was a case series [52].…”

“…Regarding oral administration, Eftekharian HR et al reported use of a single preoperative dose of 1 g orally, while Sakallioğlu Ö et al used a preoperative dose of 1 g, followed by an eight-hourly dose regimen of 1 g orally for 5 days. For topical/local administration, four studies reported topical administration either using soaked pledgets (undefined dosage) [52], soaked sponge tampons (undefined dosage) [57], or wound moistening with a 25 mg/ml TXA-saline solution [49,58]. In addition, three studies reported adding TXA to tumescent solution or local anesthetic solution [50,59,62].…”

“…However, in the same study, the rate of seroma trended towards being higher in the TXA group, although not reaching statistical significance. In addition, subgroup analysis showed that patients having lymph node clearance had a significantly increased odds of needing seroma aspiration (OR 5.71; p = 0.032), and of having a cumulative aspirated seroma volume of 500 ml or more (OR 5.72;p = 0.011), but not an increased risk of developing a chronic seroma (OR 1.50; p = 0.671), compared with the placebo group [49]. Butz et al reported use of topical TXA (soaked pledgets), in a case series of patients undergoing full face and neck rhytidectomy, to be safe and effective in reducing hematoma-related complications [52].…”

A Systematic Review of Tranexamic Acid in Plastic Surgery: What’s New?

“…The same author 33 published a similar 2-center, double-blinded, randomized clinical trial to investigate the effect of this moistening method but in 202 patients who underwent either simple mastectomy or mastectomy with sentinel node biopsy, or mastectomy with axillary lymph node clearance. The method of administration and doses was identical to those of the previous study.…”