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

Samsung Medical Center logo

Samsung Medical Center

Status and phase

Completed
Phase 2

Conditions

Cancer

Treatments

Procedure: Diathermy
Procedure: Harmonic Scalpel

Study type

Interventional

Funder types

Other

Identifiers

NCT01092468
2009-08-063

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • coagulation problem
  • refused to participate

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups, including a placebo group

Diathermy
Placebo Comparator group
Description:
Perforator flap elevation using conventional diathermy technique
Treatment:
Procedure: Diathermy
Harmonic Scalpel
Active Comparator group
Description:
Perforator flap elevation using Harmonic Scalpel
Treatment:
Procedure: Harmonic Scalpel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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