Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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
Shaista M Khan, FRCS
Study Chair
Aga Khan University
Pakistan: Aga Khan University
1519-Sur-ERC-10
NCT01587248
March 2010
August 2011
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