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Clinical Trials/NCT01092468
NCT01092468CompletedPhase 2

Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap

Samsung Medical Center2 sites in 1 country20 target enrollmentStarted: January 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
flap elevation time: from identification of skin perforator to completion of dissection to main pedicle
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •coagulation problem
  • •refused to participate

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Man Ki Chung

Assistant professor

Samsung Medical Center

Study Sites (2)

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