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

Phase 2

Completed

• Conditions: Cancer
• Interventions: Procedure: Diathermy; Procedure: Harmonic Scalpel

• Registration Number: NCT01092468
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-02
• Last Update Posted: 2011-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• head and neck reconstruction with perforator flap
• informed consent from the patient

Exclusion Criteria

• coagulation problem
• refused to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diathermy	Diathermy	Perforator flap elevation using conventional diathermy technique
Harmonic Scalpel	Harmonic Scalpel	Perforator flap elevation using Harmonic Scalpel

Primary Outcome Measures

Name	Time	Method
flap elevation time: from identification of skin perforator to completion of dissection to main pedicle	1 hour after completion of flap elevation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of