Table 2.
Variable | Treatment group | Reduction | p | |
---|---|---|---|---|
Device (n = 298) | Control (n = 298) | |||
Positive margins after initial surgery | ||||
All patients | 92/298 (30.9 %) | 124/298 (41.6 %) | 26 % | 0.008 |
At skin or fascia | 15/298 (5.0 %) | 18/298 (6.0 %) | 0.72 | |
Candidates for reexcision | 77/298 (25.8 %) | 106/298 (35.9 %) | 27 % | 0.013 |
Due to positive margin on main specimens | 47/298 (15.8 %) | 97/298 (32.9 %) | 52 % | <0.001 |
Due to positive margin on shavings | 30/298 (10.1 %) | 9/298 (3.0 %) | <0.001 | |
Reexcision lumpectomy procedures | 59/298 (19.8 %) | 77/298 (25.8 %) | 23 % | 0.097; 0.018a |
Due to positive margin on main specimens | 33/298 (10.0 %) | 62/298 (20.8 %) | 47 % | 0.002 |
Due to positive margin on shavings | 19/298 (7.4 %) | 4/298 (1.3 %) | 0.002 | |
Due to close margins or other considerations | 7/298 (2.3 %) | 11/298 (3.7 %) | 0.47 |
aAccounting for the difference between arms in the number of main lumpectomy specimens with positive margins (Fig. 2, phase I)