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Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

F

Federal University of São Paulo

Status and phase

Completed
Phase 3
Phase 2

Conditions

Breast Neoplasms

Treatments

Procedure: argon plasma coagulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02548338
34358414.9.0000.5505

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • operable breast cancer

Exclusion criteria

  • coagulation disturbs

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

electric scalpel (ES)
Other group
Description:
Breast surgery is performed using regular electric scalpel
Treatment:
Procedure: argon plasma coagulation
argon plasma coagulation (APC)
Other group
Description:
Breast surgery is performed using argon plasma coagulation scalpel
Treatment:
Procedure: argon plasma coagulation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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