Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02548338

Enrollment

Registered

2015-09-14

Start date

2014-09-30

Completion date

2015-04-30

Last updated

2015-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Brief 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.

Interventions

PROCEDUREargon 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* operable breast cancer

Exclusion criteria

* coagulation disturbs

Design outcomes

Primary

Measure	Time frame	Description
intra-operative outcomes	surgery duration	evaluate the bleeding during the surgery using weight of the surgical tissues used during the procedure.
post operative outcomes	30 days	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.

Secondary

Measure	Time frame	Description
margin damage	during the surgery	evaluate the thermal damage on the surgical peace margins produced with both scalpels.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026