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Prospective Trial Comparing the Use of Conventional Electric Scalpel and Harmonic Scalpel in Mastectomy

Phase 3
18 Years
Not Enrolling
Complication, Postoperative

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Trial Information

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

Women with breast cancer candidate to a radical mastectomy during the year of 2008.

Prospective trial with women stratified consecutive.

Inclusion Criteria:

- Breast carcinoma (ductal or lobular)

- Modified radical mastectomy was the surgery to be realized

Exclusion Criteria:

- Not inclusion criteria

- Blood dyscrasia, collagen diseases, known uncontrolled chronic diseases, infections
(mammary or axillary), ulcerated tumors and pregnancy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Differences in operative conditions and first week seroma drainage

Outcome Description:

Time of the surgery and blood loss volume during surgery. Drain volume postoperative in the first week

Outcome Time Frame:

1 week.

Safety Issue:


Principal Investigator

Edmundo C Mauad, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Director from Barretos Cancer Hospital


Brazil: National Committee of Ethics in Research

Study ID:

133/2008 HCB



Start Date:

January 2008

Completion Date:

November 2008

Related Keywords:

  • Complication, Postoperative
  • Postoperative Complications