Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction (HARMONIC001)

May 16, 2016 updated by: St Andrew's Centre for Plastic Surgery

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Chelmsford, United Kingdom
        • St. Andrew's Centre for Plastic Surgery, Broomfield Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female patients aged between 18 and 80 years old
  2. Able to comprehend, follow, and provide written informed consent.
  3. Willingness to comply with study requirements including follow-up visits

Exclusion Criteria:

  1. Patients who have a pacemaker
  2. Pregnant or breast feeding females.
  3. General contraindication for surgery as deemed by the PI (e.g. physically unfit)
  4. Patients who smoke
  5. Diabetic patients
  6. Patients who are receiving permanent analgesics
  7. Patients receiving anti-coagulation therapy.
  8. Patients with a physical or psychological condition which would impair participation in the study.
  9. Participation in any other device or drug study within 90 days prior to enrollment.
  10. Planned participation in any other medical device study during the timeframe of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Procedure: Electrocautery Diathermy
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.
Active Comparator: 1
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire
Time Frame: At surgery
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
3, 6, 12 and 24 weeks post operation
Rates of post operative infection
Time Frame: post operation for 6 months
post operation for 6 months
Incidence of abdominal (donor site) wound dehiscence
Time Frame: post operation for 6 months
post operation for 6 months
Bleeding complications
Time Frame: intra operation and for 6 months post op
intra operation and for 6 months post op
Return to theatre
Time Frame: post operation for 6 months
post operation for 6 months
Incidence of seroma
Time Frame: post operation for 6 months
post operation for 6 months
Post operative drainage from the wound
Time Frame: post operation for 6 months
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
3, 6, 12, and 24 weeks post operation
Number of days of hospitalisation
Time Frame: post operation for 6 months
post operation for 6 months
Re-operation required
Time Frame: post operation for 6 months
post operation for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Andrew's Centre for Plastic Surgery

Investigators

  • Principal Investigator: V Ramakrishnan, St Andrew's Centre for Plastic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

October 22, 2008

First Submitted That Met QC Criteria

October 22, 2008

First Posted (Estimate)

October 24, 2008

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 16, 2016

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Harmonic Scalpel HARMONIC 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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