Use of Harmonic in Breast Surgery

Breast Cancer Clinical Trial

— HMRM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587248
• Other study ID #: 1519-Sur-ERC-10
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2012
• Last updated: April 26, 2012
• Start date: March 2010
• Est. completion date: August 2011

Study information

• Verified date: April 2012
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Aga Khan University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult females with biopsy proven breast cancer underwent MRM

Exclusion Criteria:

• Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Modified Radical Mastectomy

Intervention

Device:
• Harmonic
Dissection with harmonic scalpel

Procedure:
• electrocautery
Dissection in modified radical mastectomy

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of drains (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.	30 days	No
Secondary	Operative time	Time taken in minutes from incision to skin closure	3-4 hours	No
Secondary	Drain Volume	Daily charting of drain volume at a specified time with regular recording in routine clinic follow ups till the drains were is place.	30 days	No
Secondary	Overall complications	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.	30 days	No
Secondary	Pain	Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours	24 hours	No