Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

Study Overview
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Brief Summary
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The investigators are selecting sixty (60) with breast cancer diagnoses where the surgical treatment is indicated.Furthermore the investigators divided in two groups : 1) surgical treatment using regular electric scalpel ; 2) surgical treatment using argon plasma coagulation scalpel. Our primary goal is to measure the bleeding during the surgery using the weight of the surgical tissues used. Secondary we'll evaluate the immediate post operative outcomes, like infection, hematomas and seromas. All these variables will be evaluated by a doctor using our standard clinical record and it will be measured using reliable parameters, for exemple: if the investigators clinically detect a hematoma then we'll perform an ultrasound to take the real extension; if the investigators clinically pick an infection we'll measure the extension of the hiperemia; and if the investigators clinically pick a seroma we'll drain and quantify it. Secondary the investigators going to evaluate and measure (centimeters) the terminal damage caused on the surgical specimens (samples) using the microscope.

Official Title
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Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: argon plasma coagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: operable breast cancer Exclusion Criteria: coagulation disturbs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: electric scalpel (ES)<br>Breast surgery is performed using regular electric scalpel | Procedure: argon plasma coagulation<br>* On the first group we use the regular electric scalpel to perform the surgery , and on the second group we use the argon plasma coagulation scalpel to perform the procedure.<br>|
| Other: argon plasma coagulation (APC)<br>Breast surgery is performed using argon plasma coagulation scalpel | Procedure: argon plasma coagulation<br>* On the first group we use the regular electric scalpel to perform the surgery , and on the second group we use the argon plasma coagulation scalpel to perform the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-operative outcomes | evaluate the bleeding during the surgery using weight of the surgical tissues used during the procedure. | surgery duration | 
| post operative outcomes | evaluate the occurrence of hematomas, seromas and infection using our clinical record as standard evaluation and measure it when it's possible ( like explained on the brief comments. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| margin damage | evaluate the thermal damage on the surgical peace margins produced with both scalpels. | during the surgery |