Breast Reconstruction
Conditions
Keywords
Breast Reconstruction, Halmonic Scalpel, diathermy, Free Tissue Transfer
Brief 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.
Interventions
PROCEDUREHarmonic 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.
PROCEDUREElectrocautery 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.
Sponsors
St Andrew's Centre for Plastic Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The speed of flap harvest measured as the time from knife to skin to the flap being removed from the patient. | At surgery |
Secondary
| Measure | Time frame |
|---|---|
| Re-operation required | post operation for 6 months |
| Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire | At surgery |
| 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 |
| Rates of post operative infection | post operation for 6 months |
| Incidence of abdominal (donor site) wound dehiscence | post operation for 6 months |
| Number of days of hospitalisation | post operation for 6 months |
| Return to theatre | post operation for 6 months |
| Incidence of seroma | post operation for 6 months |
| Post operative drainage from the wound | post operation for 6 months |
| Impact on daily activities (SF-36 Questionnaire) at 3, 6, 12 and 24 weeks post operatively | 3, 6, 12, and 24 weeks post operation |
| Bleeding complications | intra operation and for 6 months post op |
Countries
United Kingdom
Outcome results
None listed