Trial Comparing Electric and Harmonic Scalpel in Mastectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Complication, Postoperative

Intervention / Treatment
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* Procedure: Electric scalpel
* Procedure: Harmonic scalpel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electric Scalpel Mastectomy<br>Radical mastectomy with electric scalpel | Procedure: Electric scalpel<br>* Radical mastectomy with electric scalpel. Electric scalpels were calibrated at 40 watts of cutting and coagulation power.<br>|
| Experimental: Harmonic scalpel mastectomy<br>Radical Mastectomy with harmonic scalpel | Procedure: Harmonic scalpel<br>* Radical mastectomy with harmonic scalpel. Harmonic GEN04 generator calibrated at power leve 3 and 5, using the HP054 handpiece and HF 105 curved blade<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in local complication | Number of participants with adverse events as seroma, hematoma, skin necrosis and infection | day 7 and day 14 |