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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Man Ki Chung, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01092468
First received: March 8, 2010
Last updated: October 2, 2011
Last verified: October 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intraoperative complications: bleeding, perforator injury (thermal, mechanical) [ Time Frame: 1 hour after completion of flap elevation ] [ Designated as safety issue: Yes ]
  • postoperative drainage amount [ Time Frame: 1 week after flap inset ] [ Designated as safety issue: No ]
  • postoperative pain measured by visual analogue scale (VAS) [ Time Frame: 1 week after completion of flap elevation ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092468

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

No publications provided

Responsible Party: Man Ki Chung, Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01092468     History of Changes
Other Study ID Numbers: 2009-08-063
Study First Received: March 8, 2010
Last Updated: October 2, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
cancer
reconstruction
free flap
surgery

ClinicalTrials.gov processed this record on April 17, 2014