Clinical trial NCT01391988: Trial Comparing Electric and Harmonic Scalpel in Mastectomy
Official title: Prospective Trial Comparing the Use of Conventional Electric Scalpel and Harmonic Scalpel in Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complication, Postoperative
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective trial comparing post-operative complications and seroma formation after mastectomy in patients with breast cancer, using conventional electric scalpel and harmonic scalpel.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in operative conditions and first week seroma drainage
timeFrame: 1 week.
Secondary outcomes:
measure: Differences in local complication
timeFrame: day 7 and day 14
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Hospital de Câncer de Barretos.
state: São Paulo
Study officials:
affiliation: Director from Barretos Cancer Hospital
name: Edmundo C Mauad, MD, PhD
role: STUDY_DIRECTOR
References:
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citation: Lumachi F, Burelli P, Basso SM, Iacobone M, Ermani M. Usefulness of ultrasound scissors in reducing serous drainage after axillary dissection for breast cancer: a prospective randomized clinical study. Am Surg. 2004 Jan;70(1):80-4.
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citation: Ribeiro GH, Kerr LM, Haikel RL, Peres SV, Matthes AG, Depieri Michelli RA, Bailao A Jr, Fregnani JH, Vieira RA. Modified radical mastectomy: a pilot clinical trial comparing the use of conventional electric scalpel and harmonic scalpel. Int J Surg. 2013;11(6):496-500. doi: 10.1016/j.ijsu.2013.03.013. Epub 2013 Apr 8.