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

NCT00778947 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-05-17

No results posted yet for this study

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.

Conditions

  • Breast Reconstruction

Interventions

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.

Sponsors & Collaborators

  • St Andrew's Centre for Plastic Surgery

    lead OTHER

Principal Investigators

  • V Ramakrishnan · St Andrew's Centre for Plastic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00778947 on ClinicalTrials.gov