NCT00778947

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

May 17, 2016

Status Verified

October 1, 2008

Enrollment Period

10 months

First QC Date

October 22, 2008

Last Update Submit

May 16, 2016

Conditions

Breast Reconstruction

Keywords

Breast ReconstructionHalmonic ScalpeldiathermyFree Tissue Transfer

Outcome Measures

Primary Outcomes (1)

  • The speed of flap harvest measured as the time from "knife to skin" to the flap being removed from the patient.

    At surgery

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR
Procedure: Harmonic Synergy Dissecting Hook (Harmonic Scalpel)

2

ACTIVE COMPARATOR
Procedure: Electrocautery Diathermy

Interventions

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.

1
Electrocautery DiathermyPROCEDURE

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.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Andrew's Centre for Plastic Surgery, Broomfield Hospital,

Chelmsford, United Kingdom

Location

MeSH Terms

Conditions

Fever

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CauteryTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • V Ramakrishnan

    St Andrew's Centre for Plastic Surgery

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 24, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2009

Last Updated

May 17, 2016

Record last verified: 2008-10

Locations

GB(1)