An interventional study of Harmonic Synergy Dissecting Hook (Harmonic Scalpel) and Electrocautery Diathermy in Breast Reconstruction, sponsored by St Andrew's Centre for Plastic Surgery. Withdrawn at 1 site in United Kingdom. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-17.
Sponsored by St Andrew's Centre for Plastic Surgery · Not applicable, Interventional, and Supportive care
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.
478 studies on the registry are indexed under Hyperthermia; 92 are open to participants now.
Browse Hyperthermia studies →This is the only study on the registry with St Andrew's Centre for Plastic Surgery as lead sponsor.
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Exclusion Criteria:
Procedure: Harmonic Synergy Dissecting Hook (Harmonic Scalpel)
Procedure: Electrocautery Diathermy
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.
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.
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
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
Time frame: post operation for 6 months
Incidence of abdominal (donor site) wound dehiscence
Time frame: post operation for 6 months
Bleeding complications
Time frame: intra operation and for 6 months post op
Return to theatre
Time frame: post operation for 6 months
Incidence of seroma
Time frame: post operation for 6 months
Post operative drainage from the wound
Time frame: post operation for 6 months
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
Number of days of hospitalisation
Time frame: post operation for 6 months
Re-operation required
Time frame: post operation for 6 months
This study is withdrawn, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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