Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction - Full Text View

Sponsored by:	St Andrew's Centre for Plastic Surgery
Information provided by:	St Andrew's Centre for Plastic Surgery
ClinicalTrials.gov Identifier:	NCT00778947

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

MedlinePlus related topics: Breast Reconstruction

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer for Breast Reconstruction

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
1: Active Comparator	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.
2: Active Comparator	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:

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.

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,
Chelmsford, United Kingdom

Sponsors and Collaborators

St Andrew's Centre for Plastic Surgery

Investigators

Principal Investigator:

V Ramakrishnan

St Andrew's Centre for Plastic Surgery

More Information

Responsible Party:	St. Andrew's Centre for Plastic Surgery, Broomfield Hospital, Chelmsford ( Mr V Ramakrishnan, Consultant Plastic Surgeon )
Study ID Numbers:	Harmonic Scalpel HARMONIC 001
Study First Received:	October 22, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00778947
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 January 14, 2009