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

St Andrew's Centre for Plastic Surgery

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Conditions

Breast Reconstruction

Interventions

Harmonic Synergy Dissecting Hook (Harmonic Scalpel)PROCEDURE

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 DiathermyPROCEDURE

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

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Chelmsford, United Kingdom

Outcomes

Primary Outcomes

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 Outcomes

Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire

Time frame: 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

Rates of post operative infection