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

NCT ID: NCT01092468

Last Updated: 2011-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Diathermy

Perforator flap elevation using conventional diathermy technique

Group Type PLACEBO_COMPARATOR

Diathermy

Intervention Type PROCEDURE

flap dissection with conventional diathermy

Harmonic Scalpel

Perforator flap elevation using Harmonic Scalpel

Group Type ACTIVE_COMPARATOR

Harmonic Scalpel

Intervention Type PROCEDURE

flap dissection using harmonic scalpel (FOCUS)

Interventions

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Diathermy

flap dissection with conventional diathermy

Intervention Type PROCEDURE

Harmonic Scalpel

flap dissection using harmonic scalpel (FOCUS)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* head and neck reconstruction with perforator flap
* informed consent from the patient

Exclusion Criteria

* coagulation problem
* refused to participate
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Man Ki Chung

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2009-08-063

Identifier Type: -

Identifier Source: org_study_id