Use of Harmonic in Breast Surgery

Phase 3

Completed

• Conditions: Modified Radical Mastectomy; Breast Cancer
• Interventions: Procedure: electrocautery; Device: Harmonic

• Registration Number: NCT01587248
• Lead Sponsor: Aga Khan University

Brief 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.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Status Verified: 2012-04
• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-26
• Last Update Submitted: 2012-04-26
• Study First Posted: 2012-04-30
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 152

Inclusion Criteria

• Adult females with biopsy proven breast cancer underwent MRM

Exclusion Criteria

• Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrocautery	electrocautery	Raising of the flaps with electrocautery
Harmonic	Harmonic	Dissection with harmonic scalpel in modified radical mastectomy

Primary Outcome Measures

Name	Time	Method
Duration of drains (days)	30 days	Durations of drains in place after MRM: Patients were followed in clinic every 3rd day and drains were removed once the volume was \<30ml a day.

Secondary Outcome Measures

Name	Time	Method
Pain	24 hours	Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours
Drain Volume	30 days	Daily charting of drain volume at a specified time with regular recording in routine clinic follow ups till the drains were is place.
Overall complications	30 days	Patients were followed up till 3o days. If any of the following were found, the patient was labelled to have complication: Seroma- fluctuant swelling under the flaps; SSI- as per CDC criteria; Hematoma- swelling under flaps with characteristic bruising; Flap necrosis- partial or complete necrosis of flaps.
Operative time	3-4 hours	Time taken in minutes from incision to skin closure

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sind, Pakistan