Prospective Trial Comparing the Use of Conventional Electric Scalpel and Harmonic Scalpel in Mastectomy
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.
Women with breast cancer candidate to a radical mastectomy during the year of 2008.
Prospective trial with women stratified consecutive.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Differences in operative conditions and first week seroma drainage
Time of the surgery and blood loss volume during surgery. Drain volume postoperative in the first week
1 week.
Yes
Edmundo C Mauad, MD, PhD
Study Director
Director from Barretos Cancer Hospital
Brazil: National Committee of Ethics in Research
133/2008 HCB
NCT01391988
January 2008
November 2008
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