Status:

COMPLETED

Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction

Lead Sponsor:

Anglia Ruskin University

Collaborating Sponsors:

Mid Essex Hospital NHS Trust

Medtronic

Conditions:

Breast Reconstruction

Breast Cancer

Eligibility:

FEMALE

18-80 years

Phase:

NA

Brief Summary

Electrosurgery allows for dissection with simultaneous haemostasis. One of its disadvantages is that the heat production can cause injury to the surrounding tissue which may result in wound healing pr...

Detailed Description

The study was conducted between November 2016 and May 2018 in a single centre, St. Andrew's Centre for Plastic Surgery and Burns in Broomfield Hospital, in Chelmsford United Kingdom, including all imm...

Eligibility Criteria

Inclusion

  • Adults between 18-80 years, able to consent
  • Unilateral immediate or delayed DIEP/ MS-TRAM breast reconstruction
  • BMI \>20

Exclusion

  • Children (\<18 years) and adults older than 80 years
  • Bilateral or bi-pedicled DIEP/MS-TRAM breast reconstruction
  • BMI \<20
  • Diabetic
  • Immune-suppression
  • Clotting disorders
  • On steroid medication
  • Pregnancy
  • Active smoking

Key Trial Info

Start Date :

October 31 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2018

Estimated Enrollment :

108 Patients enrolled

Trial Details

Trial ID

NCT04350411

Start Date

October 31 2016

End Date

May 31 2018

Last Update

April 17 2020

Active Locations (1)

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Mid Essex NHS trust

Chelmsford, Essex, United Kingdom, CM17ET