NCT01587248

Use of Harmonic in Breast Surgery

Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: Female
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL), operating time, drain Volume and drain Days, seroma formation, surgical site infection and postoperative pain in adult females undergoing MRM at a tertiary care hospital. We hypothesized that harmonic yields better outcome than electrocautery dissection.

Detailed description

In this randomized controlled trial, adult females who underwent MRM between April 2010 and July 2011 were randomized to receive either intervention A (harmonic scalpel) or B (electrocautery). The procedure was standardized except elevation of flaps and axillary dissection, that was performed as per randomization. Patients were followed up in clinic for four weeks. The outcomes were estimated blood loss (EBL), operating time, drain Volume and drain Days, complications (seroma, surgical site infection, hematoma and flap necrosis) and postoperative pain.

Conditions

• Breast Cancer
• Modified Radical Mastectomy

Interventions

Type	Name	Description
DEVICE	Harmonic	Dissection with harmonic scalpel
PROCEDURE	electrocautery	Dissection in modified radical mastectomy

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-07-01
• Completion: 2011-08-01
• First posted: 2012-04-30
• Last updated: 2012-04-30

Locations

1 site across 1 country: Pakistan