NCT03167944

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"

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Seroma

Interventions

Type	Name	Description
DEVICE	Low thermal electrosurgery system	PEAK Plasmablade
DEVICE	Conventional Electrocautery	Conventional Electrocautery

Timeline

• Start date: 2017-03-15
• Primary completion: 2018-03-25
• Completion: 2018-10-30
• First posted: 2017-05-30
• Last updated: 2017-05-30

Locations

1 site across 1 country: Thailand

Regulatory

• FDA-regulated device study