Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap
Phase 2
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap
Inclusion Criteria:
- head and neck reconstruction with perforator flap
- informed consent from the patient
Exclusion Criteria:
- coagulation problem
- refused to participate
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
flap elevation time: from identification of skin perforator to completion of dissection to main pedicle
Outcome Time Frame:
1 hour after completion of flap elevation
Safety Issue:
No
Authority:
Korea: Food and Drug Administration
Study ID:
2009-08-063
NCT ID:
NCT01092468
Start Date:
January 2010
Completion Date:
August 2011
Related Keywords:
- Cancer
- cancer
- reconstruction
- free flap
- surgery
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