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

• 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 ]

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.

• 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.
• 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.

• Active Comparator: 1
  Intervention: Procedure: Harmonic Synergy Dissecting Hook (Harmonic Scalpel)
• Active Comparator: 2
  Intervention: Procedure: Electrocautery Diathermy

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.