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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by St Andrew's Centre for Plastic Surgery.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
St Andrew's Centre for Plastic Surgery
ClinicalTrials.gov Identifier:
NCT00778947
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Reconstruction
 Procedure: Harmonic Synergy Dissecting Hook (Harmonic Scalpel)
Procedure: Electrocautery Diathermy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Comparison of Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer for Breast Reconstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St Andrew's Centre for Plastic Surgery:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire [ Time Frame: At surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Rates of post operative infection [ Time Frame: post operation for 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of abdominal (donor site) wound dehiscence [ Time Frame: post operation for 6 months ] [ Designated as safety issue: Yes ]
  • Bleeding complications [ Time Frame: intra operation and for 6 months post op ] [ Designated as safety issue: Yes ]
  • Return to theatre [ Time Frame: post operation for 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of seroma [ Time Frame: post operation for 6 months ] [ Designated as safety issue: Yes ]
  • Post operative drainage from the wound [ Time Frame: post operation for 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Number of days of hospitalisation [ Time Frame: post operation for 6 months ] [ Designated as safety issue: Yes ]
  • Re-operation required [ Time Frame: post operation for 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778947

Contacts
Contact: Ceri McKenna 07941271635 ceri.appledown@virgin.net
Contact: Wendy Patterson 07769710136 wendypatterson1@hotmail.com

Locations
United Kingdom
St. Andrew's Centre for Plastic Surgery, Broomfield Hospital, Not yet recruiting
Chelmsford, United Kingdom
Principal Investigator: V Ramakrishnan            
Sponsors and Collaborators
St Andrew's Centre for Plastic Surgery
Investigators
Principal Investigator: V Ramakrishnan St Andrew's Centre for Plastic Surgery
  More Information

No publications provided

Responsible Party: Mr V Ramakrishnan, Consultant Plastic Surgeon, St. Andrew's Centre for Plastic Surgery, Broomfield Hospital, Chelmsford
ClinicalTrials.gov Identifier: NCT00778947     History of Changes
Other Study ID Numbers: Harmonic Scalpel HARMONIC 001
Study First Received: October 22, 2008
Last Updated: October 22, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by St Andrew's Centre for Plastic Surgery:
Breast Reconstruction
Halmonic Scalpel
diathermy
Free Tissue Transfer

ClinicalTrials.gov processed this record on May 19, 2013