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

Mahidol University

Status: Unknown

Conditions: Seroma

Treatments: Device: Conventional Electrocautery; Device: Low thermal electrosurgery system

Study type: Interventional

Funder types: Other

Identifiers

NCT03167944

convplas

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Conventional electrocautery

Experimental group

Treatment:

Device: Conventional Electrocautery

Low thermal electrosurgery system

Experimental group

Treatment:

Device: Low thermal electrosurgery system