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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| V Ramakrishnan | St Andrew's Centre for Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Andrew's Centre for Plastic Surgery, Broomfield Hospital, | Chelmsford | United Kingdom |
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| Electrocautery Diathermy | Procedure | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| ID | Term |
|---|---|
| D002425 | Cautery |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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