Back to resultsComparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction
Primary Purpose
Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Diathermy
Harmonic Scalpel
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring cancer, reconstruction, free flap, surgery
Eligibility Criteria
Inclusion Criteria:
- head and neck reconstruction with perforator flap
- informed consent from the patient
Exclusion Criteria:
- coagulation problem
- refused to participate
Sites / Locations
- Samsung medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Diathermy
Harmonic Scalpel
Arm Description
Perforator flap elevation using conventional diathermy technique
Perforator flap elevation using Harmonic Scalpel
Outcomes
Primary Outcome Measures
flap elevation time: from identification of skin perforator to completion of dissection to main pedicle
Secondary Outcome Measures
intraoperative complications: bleeding, perforator injury (thermal, mechanical)
postoperative drainage amount
postoperative pain measured by visual analogue scale (VAS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01092468
Brief Title
Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction
Official Title
Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
cancer, reconstruction, free flap, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diathermy
Arm Type
Placebo Comparator
Arm Description
Perforator flap elevation using conventional diathermy technique
Arm Title
Harmonic Scalpel
Arm Type
Active Comparator
Arm Description
Perforator flap elevation using Harmonic Scalpel
Intervention Type
Procedure
Intervention Name(s)
Diathermy
Intervention Description
flap dissection with conventional diathermy
Intervention Type
Procedure
Intervention Name(s)
Harmonic Scalpel
Intervention Description
flap dissection using harmonic scalpel (FOCUS)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
intraoperative complications: bleeding, perforator injury (thermal, mechanical)
Time Frame
1 hour after completion of flap elevation
Title
postoperative drainage amount
Time Frame
1 week after flap inset
Title
postoperative pain measured by visual analogue scale (VAS)
Time Frame
1 week after completion of flap elevation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
head and neck reconstruction with perforator flap
informed consent from the patient
Exclusion Criteria:
coagulation problem
refused to participate
Facility Information:
Facility Name
Samsung medical center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction
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