NCT01092468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 cancer

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 4, 2011

Status Verified

October 1, 2011

Enrollment Period

1.6 years

First QC Date

March 8, 2010

Last Update Submit

October 2, 2011

Conditions

Cancer

Keywords

cancerreconstructionfree flapsurgery

Outcome Measures

Primary Outcomes (1)

  • flap elevation time: from identification of skin perforator to completion of dissection to main pedicle

    1 hour after completion of flap elevation

Secondary Outcomes (3)

  • 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

Study Arms (2)

Diathermy

PLACEBO COMPARATOR

Perforator flap elevation using conventional diathermy technique

Procedure: Diathermy

Harmonic Scalpel

ACTIVE COMPARATOR

Perforator flap elevation using Harmonic Scalpel

Procedure: Harmonic Scalpel

Interventions

DiathermyPROCEDURE

flap dissection with conventional diathermy

Diathermy
Harmonic ScalpelPROCEDURE

flap dissection using harmonic scalpel (FOCUS)

Harmonic Scalpel

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • coagulation problem
  • refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Diathermy

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 25, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 4, 2011

Record last verified: 2011-10

Locations

KR(1)