Covidien Summary: Clinical Study

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RESULTS:
• 150 SLNBs were conducted in 136 patients; of the 14 duplicate patients, 1 underwent a second SLNB for local recurrence and 13
underwent bilateral axillary or inguinal SLNB for melanoma on the trunk
• The 150 SLNBs were conducted as follows: 70 clips, 37 with Harmonic™* scalpel, 43 with LigaSure™
• Of the 150 SLNBs, 101 (67%) involved the axilla and 49 (33%) involved the groin; there was an overall lymphocele rate of 15%: 9.9% in
axilla and 26.5% in groin
• Lymphoceles occurred in 14 cases (20%) in clips, 7 cases (18.9%) in Harmonic™*scalpel and 2 cases (4.7%) in LigaSure™
• Statistically significant rates were found between LigaSure™ and clip groups (P=.023) and for Harmonic™* scalpel and LigaSure™ groups
(p=0.044), but not between the clips and Harmonic™* scalpel groups.
• 16 (70%) of lymphoceles required aspiration; 11 in the clip group, 3 in Harmonic™* scalpel group, and 2 in LigaSure™ group; aspiration was
more likely in groin SLNB than axilla SLNB (P = 0.001)

CONCLUSION:
• In heavily studied breast procedures, post-operative fluid collection, such as lymphoceles, may result in symptoms of pain and restricted
range of motion and can be complicated by infection, wound dehiscence, flap necrosis, and prolonged hospital stay and readmission.
• The author sites previous studies that have shown electrocatuery to increase risk of post-op fluid collections compared to cold knife
dissections and inability for clips to control microscopic vascular or lymphatic vessels. This was the first known study examining the
potential lymphostatic benefit of these instruments for lymph node operations in melanoma.
• Authors concluded that risk of lymphocele was significantly reduced when the LigaSure™ was used compared to Harmonic™* scalpel
and clip group; the results from this study have led the authors to routinely use LigaSure™ for SLNB in their melanoma programs and are
studying LigaSure™ in groin and axillary dissections for melanoma.
**This concludes the clinical synopsis of this publication**