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OpenTrials
Completed

NCT Number: NCT01587248

Use of Harmonic in Breast Surgery

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Modified Radical Mastectomy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Aga Khan University

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult females with biopsy proven breast cancer underwent MRM

Exclusion criteria

  • Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)

Treatment and study plan

Harmonic

Device

Dissection with harmonic scalpel

Electrocautery

Procedure

Dissection in modified radical mastectomy

Primary outcomes

  1. Duration of drains (days)

    Time frame: 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 outcomes

  1. Operative time

    Time frame: 3-4 hours

    Time taken in minutes from incision to skin closure

  2. Drain Volume

    Time frame: 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.

  3. Overall complications

    Time frame: 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.

  4. Pain

    Time frame: 24 hours

    Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Acronym: HMRM

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 30, 2012
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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