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

Primary Purpose

Breast Reconstruction

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Harmonic Synergy Dissecting Hook (Harmonic Scalpel)
Electrocautery Diathermy
Sponsored by
St Andrew's Centre for Plastic Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Reconstruction focused on measuring Breast Reconstruction, Halmonic Scalpel, diathermy, Free Tissue Transfer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The speed of flap harvest measured as the time from "knife to skin" to the flap being removed from the patient.

Secondary Outcome Measures

Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire
Post operative pain, based on the visual analogue scale at 3, 6, 12 and 24 weeks post operatively.
Rates of post operative infection
Incidence of abdominal (donor site) wound dehiscence
Bleeding complications
Return to theatre
Incidence of seroma
Post operative drainage from the wound
Impact on daily activities (SF-36 Questionnaire) at 3, 6, 12 and 24 weeks post operatively
Number of days of hospitalisation
Re-operation required

Full Information

First Posted
October 22, 2008
Last Updated
May 16, 2016
Sponsor
St Andrew's Centre for Plastic Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT00778947
Brief Title
Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction
Acronym
HARMONIC001
Official Title
Comparison of Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer for Breast Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Withdrawn
Why Stopped
Study abandoned and was never started
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
St Andrew's Centre for Plastic Surgery

4. Oversight

5. Study Description

Brief 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 taken to return to daily activities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Reconstruction
Keywords
Breast Reconstruction, Halmonic Scalpel, diathermy, Free Tissue Transfer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Harmonic Synergy Dissecting Hook (Harmonic Scalpel)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electrocautery Diathermy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire
Time Frame
At surgery
Title
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
Title
Rates of post operative infection
Time Frame
post operation for 6 months
Title
Incidence of abdominal (donor site) wound dehiscence
Time Frame
post operation for 6 months
Title
Bleeding complications
Time Frame
intra operation and for 6 months post op
Title
Return to theatre
Time Frame
post operation for 6 months
Title
Incidence of seroma
Time Frame
post operation for 6 months
Title
Post operative drainage from the wound
Time Frame
post operation for 6 months
Title
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
Title
Number of days of hospitalisation
Time Frame
post operation for 6 months
Title
Re-operation required
Time Frame
post operation for 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
V Ramakrishnan
Organizational Affiliation
St Andrew's Centre for Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Andrew's Centre for Plastic Surgery, Broomfield Hospital,
City
Chelmsford
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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