- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01092468
Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction
October 2, 2011 updated by: Man Ki Chung, Samsung Medical Center
Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- head and neck reconstruction with perforator flap
- informed consent from the patient
Exclusion Criteria:
- coagulation problem
- refused to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Diathermy
Perforator flap elevation using conventional diathermy technique
|
flap dissection with conventional diathermy
|
Active Comparator: Harmonic Scalpel
Perforator flap elevation using Harmonic Scalpel
|
flap dissection using harmonic scalpel (FOCUS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
flap elevation time: from identification of skin perforator to completion of dissection to main pedicle
Time Frame: 1 hour after completion of flap elevation
|
1 hour after completion of flap elevation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
intraoperative complications: bleeding, perforator injury (thermal, mechanical)
Time Frame: 1 hour after completion of flap elevation
|
1 hour after completion of flap elevation
|
postoperative drainage amount
Time Frame: 1 week after flap inset
|
1 week after flap inset
|
postoperative pain measured by visual analogue scale (VAS)
Time Frame: 1 week after completion of flap elevation
|
1 week after completion of flap elevation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
March 8, 2010
First Submitted That Met QC Criteria
March 24, 2010
First Posted (Estimate)
March 25, 2010
Study Record Updates
Last Update Posted (Estimate)
October 4, 2011
Last Update Submitted That Met QC Criteria
October 2, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-08-063
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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