NCT01092468CompletedPhase 2
Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- flap elevation time: from identification of skin perforator to completion of dissection to main pedicle
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •head and neck reconstruction with perforator flap
- •informed consent from the patient
Exclusion Criteria
- •coagulation problem
- •refused to participate
Outcomes
Primary Outcomes
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
- intraoperative complications: bleeding, perforator injury (thermal, mechanical)(1 hour after completion of flap elevation)
- postoperative drainage amount(1 week after flap inset)
- postoperative pain measured by visual analogue scale (VAS)(1 week after completion of flap elevation)
Investigators
Man Ki Chung
Assistant professor
Samsung Medical Center
Study Sites (2)
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