Use of Harmonic in Breast Surgery (HMRM)

Aga Khan University

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Modified Radical Mastectomy

Treatments: Procedure: electrocautery; Device: Harmonic

Study type: Interventional

Funder types: Other

Identifiers

NCT01587248

1519-Sur-ERC-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: Female

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult females with biopsy proven breast cancer underwent MRM

Exclusion criteria

• Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 2 patient groups

Electrocautery

Active Comparator group

Description:

Raising of the flaps with electrocautery

Treatment:

Procedure: electrocautery

Harmonic

Experimental group

Description:

Dissection with harmonic scalpel in modified radical mastectomy

Treatment:

Device: Harmonic