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

Breast Reconstruction Clinical Trial

— HARMONIC001  

Official title:

Comparison of Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer for Breast Reconstruction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00778947
• Other study ID #: Harmonic Scalpel HARMONIC 001
• Status: Withdrawn
• Phase: N/A
• First received: October 22, 2008
• Last updated: May 16, 2016
• Start date: November 2008

Study information

• Verified date: October 2008
• Source: St Andrew's Centre for Plastic Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 taken to return to daily activities.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	St. Andrew's Centre for Plastic Surgery, Broomfield Hospital,	Chelmsford

Sponsors (1)

Lead Sponsor	Collaborator
St Andrew's Centre for Plastic Surgery

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The speed of flap harvest measured as the time from "knife to skin" to the flap being removed from the patient.		At surgery	No
Secondary	Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire		At surgery	No
Secondary	Post operative pain, based on the visual analogue scale at 3, 6, 12 and 24 weeks post operatively.		3, 6, 12 and 24 weeks post operation	Yes
Secondary	Rates of post operative infection		post operation for 6 months	Yes
Secondary	Incidence of abdominal (donor site) wound dehiscence		post operation for 6 months	Yes
Secondary	Bleeding complications		intra operation and for 6 months post op	Yes
Secondary	Return to theatre		post operation for 6 months	Yes
Secondary	Incidence of seroma		post operation for 6 months	Yes
Secondary	Post operative drainage from the wound		post operation for 6 months	Yes
Secondary	Impact on daily activities (SF-36 Questionnaire) at 3, 6, 12 and 24 weeks post operatively		3, 6, 12, and 24 weeks post operation	Yes
Secondary	Number of days of hospitalisation		post operation for 6 months	Yes
Secondary	Re-operation required		post operation for 6 months	Yes