Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

NCT02548338 | Completed Phase 2 DMC

• 1 other identifier: 34358414.9.0000.5505
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

• intra-operative outcomes

  evaluate the bleeding during the surgery using weight of the surgical tissues used during the procedure.

  surgery duration

• 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

Secondary Outcomes (1)

• margin damage

  during the surgery

Study Arms (2)

electric scalpel (ES)

OTHER

Breast surgery is performed using regular electric scalpel

Procedure: argon plasma coagulation

argon plasma coagulation (APC)

OTHER

Breast surgery is performed using argon plasma coagulation scalpel

Procedure: argon plasma coagulation

Interventions

argon plasma coagulation PROCEDURE

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.

argon plasma coagulation (APC); electric scalpel (ES)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• operable breast cancer

You may not qualify if:

• coagulation disturbs

Sponsors & Collaborators

• Federal University of São Paulo: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electrocoagulation; Cautery; Therapeutics; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: September 14, 2015
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: April 1, 2015
• Last Updated: September 14, 2015

Record last verified: 2015-08