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

Seroma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03167944
• Other study ID #: convplas
• Status: Recruiting
• Phase: N/A
• First received: May 23, 2017
• Last updated: May 24, 2017
• Start date: March 15, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: May 2017
• Source: Mahidol University
• Contact: Piratthima Vachiraprakarnsakul
• Phone: +66830693791
• Email: piratthima.v[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2018
• Est. primary completion date: March 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Seroma

Intervention

Device:
• Low thermal electrosurgery system
PEAK Plasmablade
• Conventional Electrocautery
Conventional Electrocautery

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

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