Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548338
• Other study ID #: 34358414.9.0000.5505
• 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

• Breast Neoplasms

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