Breast ReconstructionHARMONIC001NCT00778947
Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction
A study testing Harmonic Synergy Dissecting Hook (Harmonic Scalpel) and Electrocautery Diathermy in people with Breast Reconstruction, run by St Andrew's Centre for Plastic Surgery at 1 site in United Kingdom.
Trial summary
The purpose of this single centre study is to evaluate whether the use of Harmonic Synergy Dissecting Hook (Harmonic Scalpel) in breast reconstruction surgery is superior to conventional diathermy in terms of improving ease and speed of perforator dissection, reducing postoperative pain, days of hospital stay and time… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Harmonic Synergy Dissecting Hook (Harmonic Scalpel) and Electrocautery Diathermy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2008to Sep 2009
- Phase
- Interventional
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged between 18 and 80 years old
- Able to comprehend, follow, and provide written informed consent.
- Willingness to comply with study requirements including follow-up visits
Who cannot join
- Patients who have a pacemaker
- Pregnant or breast feeding females.
- General contraindication for surgery as deemed by the PI (e.g. physically unfit)
- Patients who smoke
- Diabetic patients
- Patients who are receiving permanent analgesics
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- Patients receiving anti-coagulation therapy.
- Patients with a physical or psychological condition which would impair participation in the study.
- Participation in any other device or drug study within 90 days prior to enrollment.
- Planned participation in any other medical device study during the timeframe of this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St. Andrew's Centre for Plastic Surgery, Broomfield Hospital,
Chelmsford
About this study
Official title: Comparison of Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer for Breast Reconstruction
The purpose of this single centre study is to evaluate whether the use of Harmonic Synergy Dissecting Hook (Harmonic Scalpel) in breast reconstruction surgery is superior to conventional diathermy in terms of improving ease and speed of perforator dissection, reducing postoperative pain, days of hospital stay and time taken to return to daily activities.
- Conditions
- Breast Reconstruction
- Being tested
- Harmonic Synergy Dissecting Hook (Harmonic Scalpel), Electrocautery Diathermy
- Keywords
- Breast Reconstruction, Halmonic Scalpel, diathermy, Free Tissue Transfer
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic Synergy Dissecting Hook (Harmonic Scalpel)Procedure or surgery
Harmonic Synergy Dissecting Hook (Harmonic Scalpel) uses ultrasound waves to coagulate and cut in surgery. It is available on the market, holds a CE mark and is coded as a Class IIb medical device.
Electrocautery DiathermyProcedure or surgery
Electrosurgery uses high temperatures (150-400oC) and causes obliterative coagulation. Diathermy is the use of high frequency electric current to produce heat. In surgery it is used to cut or destroy tissue and/or to produce coagulation. The electrical frequency produced in diathermy is in the range of 300kHz to 3MHz.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: Harmonic Synergy Dissecting Hook (Harmonic Scalpel) |
| 2 | Active comparator | Not described Receives: Procedure: Electrocautery Diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The speed of flap harvest measured as the time from "knife to skin" to the flap being removed from the patient.
Measured: At surgery
Secondary outcomes (11)
Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire
Measured: At surgery
Post operative pain, based on the visual analogue scale at 3, 6, 12 and 24 weeks post operatively.
Measured: 3, 6, 12 and 24 weeks post operation
Rates of post operative infection
Measured: post operation for 6 months
Incidence of abdominal (donor site) wound dehiscence
Measured: post operation for 6 months
Bleeding complications
Measured: intra operation and for 6 months post op
Return to theatre
Measured: post operation for 6 months
Incidence of seroma
Measured: post operation for 6 months
Post operative drainage from the wound
Measured: post operation for 6 months
Impact on daily activities (SF-36 Questionnaire) at 3, 6, 12 and 24 weeks post operatively
Measured: 3, 6, 12, and 24 weeks post operation
Number of days of hospitalisation
Measured: post operation for 6 months
Re-operation required
Measured: post operation for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2009 (estimated)
Why it stopped: Study abandoned and was never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Andrew's Centre for Plastic Surgery
- Sponsor type
- University, hospital or other
- Investigators
- V Ramakrishnan, Principal investigator, St Andrew's Centre for Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778947
- Sponsor's protocol ID
- Harmonic Scalpel HARMONIC 001
- Acronym
- HARMONIC001
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 17 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer for Breast Reconstruction
- ClinicalTrials.gov ID
- NCT00778947
- Acronym / sponsor ID
- HARMONIC001 / Harmonic Scalpel HARMONIC 001
- Conditions
- Breast Reconstruction
- Keywords
- Breast Reconstruction, Halmonic Scalpel, diathermy, Free Tissue Transfer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study abandoned and was never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St Andrew's Centre for Plastic SurgeryUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (estimated)
- First posted
- 24 Oct 2008 (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.
The purpose of this single centre study is to evaluate whether the use of Harmonic Synergy Dissecting Hook (Harmonic Scalpel) in breast reconstruction surgery is superior to conventional diathermy in terms of improving ease and speed of perforator dissection, reducing postoperative pain, days of hospital stay and time taken to return to daily activities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Harmonic Synergy Dissecting Hook (Harmonic Scalpel) |
| 2 | Active comparator | Procedure: Electrocautery Diathermy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged between 18 and 80 years old
- Able to comprehend, follow, and provide written informed consent.
- Willingness to comply with study requirements including follow-up visits
Key exclusion criteria (10 listed)
- Patients who have a pacemaker
- Pregnant or breast feeding females.
- General contraindication for surgery as deemed by the PI (e.g. physically unfit)
- Patients who smoke
- Diabetic patients
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 Synergy Dissecting Hook (Harmonic Scalpel)Harmonic Synergy Dissecting Hook (Harmonic Scalpel) uses ultrasound waves to coagulate and cut in surgery. It is available on the market, holds a CE mark and is coded as a Class IIb medical device. | Procedure or surgery | 1 |
| Electrocautery DiathermyElectrosurgery uses high temperatures (150-400oC) and causes obliterative coagulation. Diathermy is the use of high frequency electric current to produce heat. In surgery it is used to cut or destroy tissue and/or to produce coagulation. The electrical frequency produced in diathermy is in the range of 300kHz to 3MHz. | Procedure or surgery | 2 |
Primary outcome
The speed of flap harvest measured as the time from "knife to skin" to the flap being removed from the patient.
Time frame: At surgery
11 secondary outcomes
Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire
Time frame: At surgery
Post operative pain, based on the visual analogue scale at 3, 6, 12 and 24 weeks post operatively.
Time frame: 3, 6, 12 and 24 weeks post operation
Rates of post operative infection
Time frame: post operation for 6 months
Incidence of abdominal (donor site) wound dehiscence
Time frame: post operation for 6 months
Bleeding complications
Time frame: intra operation and for 6 months post op
Return to theatre
Time frame: post operation for 6 months
Incidence of seroma
Time frame: post operation for 6 months
Post operative drainage from the wound
Time frame: post operation for 6 months
Impact on daily activities (SF-36 Questionnaire) at 3, 6, 12 and 24 weeks post operatively
Time frame: 3, 6, 12, and 24 weeks post operation
Number of days of hospitalisation
Time frame: post operation for 6 months
Re-operation required
Time frame: post operation for 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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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.
V Ramakrishnan principal investigator
St Andrew's Centre for Plastic Surgery
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 Synergy Dissecting Hook (Harmonic Scalpel) and Electrocautery Diathermy in people with Breast Reconstruction, run by St Andrew's Centre for Plastic Surgery at 1 site in United Kingdom.
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 3 inclusion and 10 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: withdrawn, as of the sponsor's last update on 17 May 2016. 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 Kingdom. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The speed of flap harvest measured as the time from "knife to skin" to the flap being removed from the patient. (time frame: At surgery). 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 17 May 2016.