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. 2019 Dec 26;4(2):216–224. doi: 10.1002/bjs5.50248

Table 3.

Exploratory subgroup analysis: adjusted primary and secondary outcomes according to administration of tranexamic acid versus placebo, stratified for type of surgery

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.