Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Procedure: argon plasma coagulation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• operable breast cancer

Exclusion Criteria:

• coagulation disturbs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: electric scalpel (ES); Breast surgery is performed using regular electric scalpel	Procedure: argon plasma coagulation; 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.
OTHER: argon plasma coagulation (APC); Breast surgery is performed using argon plasma coagulation scalpel	Procedure: argon plasma coagulation; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (ESTIMATE): September 14, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): September 14, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 34358414.9.0000.5505