HyperplasiaNCT00819260

Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

A study testing Harmonic Scalpel and Electrocautery in people with Hyperplasia, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery. The three metrics are: 1. the time taken to complete the operation 2. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Hyperplasia
What is being tested?: Harmonic Scalpel and Electrocautery
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Feb 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients are eligible for enrollment if they agree to provide informed consent, can read and speak English, are at least 18 years of age, and are in generally good health.

Who cannot join

under 18 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery

The three metrics are:

the time taken to complete the operation
drainage volume in the days immediately following surgery,
patient pain in the days immediately following surgery.

Conditions: Hyperplasia
Being tested: Harmonic Scalpel, Electrocautery
Keywords: Mammaplasty, Electrocoagulation, Breast
Medical subject headings: Hyperplasia, Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Harmonic ScalpelDevice
harmonic scalpel used to reduce breast on this side
ElectrocauteryDevice
Electrocautery used to reduce breast on this side

Study groups in NCT00819260
Study group	Role	What they receive
Harmonic Reduced Breast	Experimental	harmonic scalpel used to reduce breast on that side Receives: Device: Harmonic Scalpel
Electrocautery Reduced Breast	Active comparator	Electrocautery (current practice = control) used to reduce breast on that side Receives: Device: Electrocautery

What is being measured

The primary outcome is the main question the study is designed to answer.

Time for Operation
Time to complete the breast reduction per breast.
Measured: day of surgery

Secondary outcomes (3)

Volume of Drainage in Surgical Drains
An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour.
Measured: within one week of surgery
Pain Level in Surgical Sites
An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable.
Measured: first week after surgery
Hematoma
A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.
Measured: first day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Feb 2010

First posted8 Jan 2009 (estimated)
Study startMar 2009
Primary completionJan 2010
Study completionFeb 2010

Why it stopped: Significant result achieved after enrollment of 31 of planned 50 subjects.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HyperplasiaStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00819260
Sponsor's protocol ID: 1182DF9
Status last verified: May 2013
First submitted: 6 Jan 2009
Last updated: 20 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery
ClinicalTrials.gov ID: NCT00819260
Acronym / sponsor ID: 1182DF9
Conditions: Hyperplasia
Keywords: Mammaplasty, Electrocoagulation, Breast
Study type: Interventional
Recruitment status: TerminatedReason stopped: Significant result achieved after enrollment of 31 of planned 50 subjects.
Enrolment: 31 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: Ethicon Endo-Surgery
Study start: Mar 2009
Primary completion: Jan 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 8 Jan 2009 (estimated)
Results: Posted 20 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The three metrics are:

the time taken to complete the operation
drainage volume in the days immediately following surgery,
patient pain in the days immediately following surgery.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Harmonic Reduced Breast	Experimental	Device: Harmonic Scalpelharmonic scalpel used to reduce breast on that side
Electrocautery Reduced Breast	Active comparator	Device: ElectrocauteryElectrocautery (current practice = control) used to reduce breast on that side

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients are eligible for enrollment if they agree to provide informed consent, can read and speak English, are at least 18 years of age, and are in generally good health.

Key exclusion criteria (1 listed)

under 18 years of age

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
Harmonic Scalpelharmonic scalpel used to reduce breast on this side	Device	Harmonic Reduced Breast
ElectrocauteryElectrocautery used to reduce breast on this side	Device	Electrocautery Reduced Breast

Primary outcome

Time for Operation
Time frame: day of surgery
Time to complete the breast reduction per breast.

3 secondary outcomes

Volume of Drainage in Surgical Drains
Time frame: within one week of surgery
Pain Level in Surgical Sites
Time frame: first week after surgery
Hematoma
Time frame: first day after surgery

Results and safety

Results posted to the registry on 20 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	31	31

Primary outcome: Time for Operation

Time frame: day of surgery. Median (Standard Deviation). Unit: minutes

Measure	Harmonic Reduced Breast n = 31	Electrocautery Reduced Breast n = 31
Value	32.9 (14.7)	31 (8.1)

Population analysed: Women over the age of 18 who are not pregnant with symptomatic breast hypertrophy who underwent breast reduction surgery.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Harmonic Reduced Breast	1 of 31 (3.2%)	0 of 31 (0%)	Not reported
Electrocautery Reduced Breast	0 of 31 (0%)	0 of 31 (0%)	Not reported

Limitations and caveats (from the sponsor): We made a first analysis after 26 (intended enrollment 50) patients were enrolled and a result was strongly suggested. While the analysis was refined, 5 more patients enrolled. The study was then stopped after 31 patients enrolled.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hyperplasia

Active, not recruitingPhase 1/2
RT-310 Safety and Feasibility BPH Study
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RecruitingPhase 2
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Urinary Urge Incontinence, Stress Urinary Incontinence
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
Lymphoproliferative Disorder, HHV-8
Not yet recruiting
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
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Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
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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.

Carolyn L Kerrigan, MD principal investigator

DHMC

Todd E Burdette, MD study director

DHMC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Harmonic Scalpel and Electrocautery in people with Hyperplasia, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 20 May 2013. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time for Operation (time frame: day of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00819260.

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 20 May 2013.