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Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

NCT02548338 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-09-14

No results posted yet for this study

Summary

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.

Conditions

  • Breast Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-11-30
Completion
2015-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02548338 on ClinicalTrials.gov