Cancer
Conditions
Keywords
cancer, reconstruction, free flap, surgery
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.
Interventions
PROCEDUREDiathermy
flap dissection with conventional diathermy
PROCEDUREHarmonic Scalpel
flap dissection using harmonic scalpel (FOCUS)
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* head and neck reconstruction with perforator flap * informed consent from the patient
Exclusion criteria
* coagulation problem * refused to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| flap elevation time: from identification of skin perforator to completion of dissection to main pedicle | 1 hour after completion of flap elevation |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed