Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction

Samsung Medical Center20 enrolled

Overview

This study is to compare the efficacy of Harmonic Scalpel with conventional diathermy technique in terms of reducing elevation time and perioperative complications of perforator flaps for head and neck reconstruction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cancer

Interventions

DiathermyPROCEDURE

flap dissection with conventional diathermy

Harmonic ScalpelPROCEDURE

flap dissection using harmonic scalpel (FOCUS)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * head and neck reconstruction with perforator flap * informed consent from the patient Exclusion Criteria: * coagulation problem * refused to participate

Locations (1)

Samsung medical center

Seoul, South Korea

Outcomes

Primary Outcomes

flap elevation time: from identification of skin perforator to completion of dissection to main pedicle

Time frame: 1 hour after completion of flap elevation

Secondary Outcomes

intraoperative complications: bleeding, perforator injury (thermal, mechanical)

Time frame: 1 hour after completion of flap elevation

postoperative drainage amount

Time frame: 1 week after flap inset

postoperative pain measured by visual analogue scale (VAS)

Time frame: 1 week after completion of flap elevation

Data from ClinicalTrials.gov

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