Table 2.
Outcome data
| TXA | Placebo | TXA versus placebo* | ||||
|---|---|---|---|---|---|---|
| Effect size | Adjusted difference## | |||||
| OR† | P ‡‡ | OR† | P *** | |||
| Primary outcome | n = 101 | n = 101 | ||||
| Mean drain production in first 24 h (ml)* | 110 (97, 123) | 144 (122, 167) | −34 (−60, −8)‡ | 0·011§§ | −32·4 (−51·4, −15·8)¶ | < 0·001††† |
| Secondary outcomes # | n = 100 | n = 94 | ||||
| Early haematoma** | 1 (1·0) | 7 (7) | 0·13 (0·02, 1·11) | 0·065¶¶ | 0·13 (0·02, 1·07) | 0·057 |
| Mean total drain production (ml)* | 189 (145, 234) | 214 (165, 264) | −25 (−91, 41)‡ | 0·461§§ | −33·0 (−60·0, −10·4)¶ | 0·003††† |
| Mean time with drain (days)* | 1·7 (1·4, 1·9) | 1·8 (1·6, 2·1) | −0·1 (−0·7, 0·2)§ | 0·341§§ | −15·6 (−30·2, −2·6)¶ | 0·017††† |
| Drain removed at 24 h | 65 (65·0) | 47 (50) | 1·86 (1·04, 3·31) | 0·035 | 3·00 (1·44, 6·22) | 0·003 |
| Mean drain production in 24 h before removal (ml)* | 93 (82, 105) | 91 (80, 102) | 2 (−13, 18)‡ | 0·783§§ | −6·4 (−22·3, 8·10)¶ | 0·083††† |
| Late haematoma, postoperative infection or wound rupture | 13 (13·0) | 10 (11) | 1·26 (0·52, 3·02) | 0·721 | 1·11 (0·45, 2·73) | 0·824 |
| Thromboembolic event | 0 (0) | 0 (0) | ||||
| Seroma †† | n = 87 | n = 84 | ||||
| Aspiration required | 69 (79) | 56 (67) | 1·92 (0·96, 3·82) | 0·062 | 1·83 (0·91, 3·68) | 0·089 |
| ≥ 5 aspirations | 19 (22) | 17 (20) | 1·10 (0·53, 2·30) | 0·797 | 0·87 (0·38, 2·00) | 0·740 |
| Cumulative seroma ≥ 500 ml | 34 (39) | 20 (24) | 2·05 (1·06, 3·98) | 0·033 | 1·99 (0·94, 4·23) | 0·073 |
| Chronic seroma | 6 (7) | 11 (13) | 0·49 (0·17, 1·40) | 0·182 | 0·41 (0·14, 1·21) | 0·107 |
Values in parentheses are percentages unless indicated otherwise;
values in parentheses are 95 per cent confidence intervals.
Odds ratio (OR) unless indicated otherwise; values are
millilitres,
days and
percentages.
Number of patients with early haematoma calculated from all patients;
patients with early haematoma excluded from other secondary postoperative outcome registrations;
patients with early or late haematoma, infection or wound rupture excluded from seroma registrations. TXA, tranexamic acid.
χ2 test, except
independent‐samples Student's t test and
Fisher's exact test.
Regression analyses, adjusted according to axillary clearance, study centre, wound surface area and surgeon seniority:
logistic regression model, except
general linear model (ratio between logarithmic mean as percentage difference).