Table 3.
TXA versus placebo | ||||
---|---|---|---|---|
Simple mastectomy/SNB (n = 137)* | P | Axillary clearance (n = 65)† | P | |
Primary outcome | ||||
Drain production in first 24 h‡§ | −33·4 (−58·1, −12·6) | 0·001 | −27 (−56, −3) | 0·026 |
Secondary outcomes ¶ | ||||
Early haematoma | TXA 1 versus placebo 3†† | 0·620 | TXA 0 versus placebo 4†† | 0·046 |
Total drain production‡§ | −32·3 (−62·4, −9·4) | 0·005 | −27 (−92, 18) | 0·244 |
Time with drain‡ | −11·6 (−24·9, −0·2) | 0·054 | −23 (−65, 9) | 0·166 |
Drain removed at 24 h# | 2·41 (1·02, 5·68) | 0·044 | 5·70 (1·27, 25·6) | 0·023 |
Drain volume in 24 h before removal‡ | −11·3 (−30·3, 5·3) | 0·185 | 5·2 (−40, 26) | 0·721 |
Late haematoma, postoperative infection or wound rupture# | 1·01 (0·33, 3·06) | 0·985 | 1·27 (0·24, 6·62) | 0·778 |
Seroma ** | ||||
Aspiration required# | 1·32 (0·59, 2·97) | 0·500 | 5·71 (1·16, 28·2) | 0·032 |
≥ 5 aspirations# | 0·47 (0·15, 1·50) | 0·203 | 1·88 (0·54, 6·49) | 0·320 |
Cumulative seroma ≥ 500 ml# | 1·08 (0·41, 2·81) | 0·880 | 5·72 (1·50, 21·9) | 0·011 |
Chronic seroma# | 0·18 (0·04, 0·89) | 0·035 | 1·50 (0·23, 9·73) | 0·671 |
Values in parentheses are 95 per cent confidence intervals.
Tranexamic acid (TXA) (67 patients) versus placebo (70);
TXA (34) versus placebo (31).
Ratio between logarithmic mean as percentage difference; univariable general linear model adjusted for study centre and wound surface area; §additionally adjusted for surgeon seniority.
Number of patients with early haematoma calculated from all patients; patients with early haematoma excluded from other secondary postoperative outcome registrations.
Odds ratio: logistic regression model adjusted for study centre and wound surface area.
Patients with early or late haematoma, infection or wound rupture excluded from seroma registrations. SNB, sentinel node biopsy;
Fisher's exact test owing to number of patients being too low for logistic regression analysis.