Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy

"Comparison of Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy: A Prospective Randomized Controlled Trial"

Breast cancer is one of the most common cancer among women nowadays. There are lots of modality of treatment and one of them is Mastectomy. We found out that seroma is one of the disturbing postoperative complications after mastectomy. In our study we want to compare the outcome between using the conventional electrocautery and the low thermal tissue dissection. We expected that the serum production should be lower in cases using low thermal system electrosurgery system.

Study Overview

• Status: Unknown
• Conditions: Seroma
• Intervention / Treatment: Device: Conventional Electrocautery; Device: Low thermal electrosurgery system

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Faculty of Medicine, Siriraj Hospital
    • Contact: Piratthima Vachiraprakarnsakul; Phone Number: +66830693791
    • Principal Investigator: Piratthima Vachiraprakarnsakul, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female aged >18 years old
• Patients that fulfill the indication of mastectomy
• Medium-sized breast volume (Breast weight < 1500 grams)

Exclusion Criteria:

• Patients who cannot complete the informed consent
• Patients with ASA CLASS > 3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Conventional electrocautery	Device: Conventional Electrocautery; Conventional Electrocautery
EXPERIMENTAL: Low thermal electrosurgery system	Device: Low thermal electrosurgery system; PEAK Plasmablade

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drainage volume after surgery	Drainage volume detected after surgery which is measured in drainage container and measured by syringe gauge aspiration	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative Pain	Post-operative Pain measured using 0-10 Numeric pain scale	Up to 24 weeks
Patient's Hospital costs	Expenses that the patient has to pay while staying in the hospital	up to 1 week
Wound infection	Wound infection after surgery	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2017
• Primary Completion (ANTICIPATED): March 25, 2018
• Study Completion (ANTICIPATED): October 30, 2018

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (ACTUAL): May 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Mastectomy; Seroma
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Seroma
• Other Study ID Numbers: convplas

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes