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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Reconstruction

Intervention / Treatment
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* Procedure: Harmonic Synergy Dissecting Hook (Harmonic Scalpel)
* Procedure: Electrocautery Diathermy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Procedure: Harmonic Synergy Dissecting Hook (Harmonic Scalpel)<br>* 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.<br>|
| Active Comparator: 2<br> | Procedure: Electrocautery Diathermy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Bleeding complications |  | intra operation and for 6 months post op | 
| 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 | 
| Number of days of hospitalisation |  | post operation for 6 months | 
| Re-operation required |  | post operation for 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Reconstruction, Halmonic Scalpel, diathermy, Free Tissue Transfer