CancerPhase 2NCT01092468
Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction
A Phase 2 study testing Diathermy and Harmonic Scalpel in people with Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Diathermy and Harmonic Scalpel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- head and neck reconstruction with perforator flap
- informed consent from the patient
Who cannot join
- coagulation problem
- refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- Diathermy, Harmonic Scalpel
- Keywords
- cancer, reconstruction, free flap, surgery
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiathermyProcedure or surgery
flap dissection with conventional diathermy
Harmonic ScalpelProcedure or surgery
flap dissection using harmonic scalpel (FOCUS)
| Study group | Role | What they receive |
|---|---|---|
| Diathermy | Placebo comparator | Perforator flap elevation using conventional diathermy technique Receives: Procedure: Diathermy |
| Harmonic Scalpel | Active comparator | Perforator flap elevation using Harmonic Scalpel Receives: Procedure: Harmonic Scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
flap elevation time: from identification of skin perforator to completion of dissection to main pedicle
Measured: 1 hour after completion of flap elevation
Secondary outcomes (3)
intraoperative complications: bleeding, perforator injury (thermal, mechanical)
Measured: 1 hour after completion of flap elevation
postoperative drainage amount
Measured: 1 week after flap inset
postoperative pain measured by visual analogue scale (VAS)
Measured: 1 week after completion of flap elevation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Man Ki Chung, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092468
- Sponsor's protocol ID
- 2009-08-063
- Status last verified
- Oct 2011
- First submitted
- 8 Mar 2010
- Last updated
- 4 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap
- ClinicalTrials.gov ID
- NCT01092468
- Acronym / sponsor ID
- 2009-08-063
- Conditions
- Cancer
- Keywords
- cancer, reconstruction, free flap, surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diathermy | Placebo comparator | Procedure: DiathermyPerforator flap elevation using conventional diathermy technique |
| Harmonic Scalpel | Active comparator | Procedure: Harmonic ScalpelPerforator flap elevation using Harmonic Scalpel |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- head and neck reconstruction with perforator flap
- informed consent from the patient
Key exclusion criteria (2 listed)
- coagulation problem
- refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diathermyflap dissection with conventional diathermy | Procedure or surgery | Diathermy |
| Harmonic Scalpelflap dissection using harmonic scalpel (FOCUS) | Procedure or surgery | Harmonic Scalpel |
Primary outcome
flap elevation time: from identification of skin perforator to completion of dissection to main pedicle
Time frame: 1 hour after completion of flap elevation
3 secondary outcomes
intraoperative complications: bleeding, perforator injury (thermal, mechanical)
Time frame: 1 hour after completion of flap elevation
postoperative drainage amount
Time frame: 1 week after flap inset
postoperative pain measured by visual analogue scale (VAS)
Time frame: 1 week after completion of flap elevation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diathermy and Harmonic Scalpel in people with Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flap elevation time: from identification of skin perforator to completion of dissection to main pedicle (time frame: 1 hour after completion of flap elevation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2011.