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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01092468
First Posted: March 25, 2010
Last Update Posted: October 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Man Ki Chung, Samsung Medical Center
  Purpose
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.

Condition Intervention Phase
Cancer Procedure: Diathermy Procedure: Harmonic Scalpel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap

Further study details as provided by Man Ki Chung, Samsung Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • coagulation problem
  • refused to participate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092468


Locations
Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Man Ki Chung, Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01092468     History of Changes
Other Study ID Numbers: 2009-08-063
First Submitted: March 8, 2010
First Posted: March 25, 2010
Last Update Posted: October 4, 2011
Last Verified: October 2011

Keywords provided by Man Ki Chung, Samsung Medical Center:
cancer
reconstruction
free flap
surgery