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Completed

NCT Number: NCT01092468

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Samsung medical center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • coagulation problem
  • refused to participate

Treatment and study plan

Diathermy

Procedure

flap dissection with conventional diathermy

Harmonic scalpel

Procedure

flap dissection using harmonic scalpel (FOCUS)

Primary outcomes

  1. 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

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

    Time frame: 1 hour after completion of flap elevation

  2. postoperative drainage amount

    Time frame: 1 week after flap inset

  3. postoperative pain measured by visual analogue scale (VAS)

    Time frame: 1 week after completion of flap elevation

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 25, 2010
Registry last updated
Oct 4, 2011

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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