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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diathermy | Placebo Comparator | Perforator flap elevation using conventional diathermy technique |
|
| Harmonic Scalpel | Active Comparator | Perforator flap elevation using Harmonic Scalpel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diathermy | Procedure | flap dissection with conventional diathermy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| flap elevation time: from identification of skin perforator to completion of dissection to main pedicle | 1 hour after completion of flap elevation |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative complications: bleeding, perforator injury (thermal, mechanical) | 1 hour after completion of flap elevation | |
| postoperative drainage amount | 1 week after flap inset | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung medical center | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| Harmonic Scalpel |
| Procedure |
flap dissection using harmonic scalpel (FOCUS) |
|
| postoperative pain measured by visual analogue scale (VAS) |
| 1 week after completion of flap elevation |