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

October 2, 2011 updated by: Man Ki Chung, Samsung Medical Center

Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • coagulation problem
  • refused to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Diathermy
Perforator flap elevation using conventional diathermy technique
Procedure: Diathermy
flap dissection with conventional diathermy
Active Comparator: Harmonic Scalpel
Perforator flap elevation using Harmonic Scalpel
Procedure: Harmonic Scalpel
flap dissection using harmonic scalpel (FOCUS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
flap elevation time: from identification of skin perforator to completion of dissection to main pedicle
Time Frame: 1 hour after completion of flap elevation
1 hour after completion of flap elevation

Secondary Outcome Measures

Outcome Measure
Time Frame
intraoperative complications: bleeding, perforator injury (thermal, mechanical)
Time Frame: 1 hour after completion of flap elevation
1 hour after completion of flap elevation
postoperative drainage amount
Time Frame: 1 week after flap inset
1 week after flap inset
postoperative pain measured by visual analogue scale (VAS)
Time Frame: 1 week after completion of flap elevation
1 week after completion of flap elevation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

October 4, 2011

Last Update Submitted That Met QC Criteria

October 2, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-08-063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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