Complication, Postoperative Clinical Trial
Official title:
Prospective Trial Comparing the Use of Conventional Electric Scalpel and Harmonic Scalpel in Mastectomy
Prospective trial comparing post-operative complications and seroma formation after mastectomy in patients with breast cancer, using conventional electric scalpel and harmonic scalpel.
The population of this study was formed by women aged older than 18 years old, with breast
carcinoma (ductal ou lobular) at any stage, form whom modified radical mastectomy is
proposed. Patients were excluded if the present blood dyscrasia, collagen diseases, known
uncontrolled chronic disease, infections (mammary or axillary, ulcerated tumors and
pregnancy. The women were submitted to modified radical mastectomy consecutive allocated in
electric scalpel group and the other group with harmonic scalpel.
Electric scalpels were calibrated at 40 watts of cutting and coagulation power and harmonic
scalpel with a GEN04 generator calibrated at power levels 3 and 5, using the HP054 handpiece
and HF105 curved blade.
Local postoperative complications analysed were seroma, hematoma, skin necrosis and
infection.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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