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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02548338
Other study ID # 34358414.9.0000.5505
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received July 28, 2015
Last updated September 11, 2015
Start date September 2014
Est. completion date April 2015

Study information

Verified date August 2015
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 2015
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- operable breast cancer

Exclusion Criteria:

- coagulation disturbs

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary intra-operative outcomes evaluate the bleeding during the surgery using weight of the surgical tissues used during the procedure. surgery duration No
Primary 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 No
Secondary margin damage evaluate the thermal damage on the surgical peace margins produced with both scalpels. during the surgery No
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