Status:

COMPLETED

Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps

Lead Sponsor:

University of Manitoba

Collaborating Sponsors:

Keeping Abreast Charity

Conditions:

DIEP Flap Breast Reconstruction

SIEA Flap Breast Reconstruction

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

The Deep Inferior Epigastric Perforator flap (DIEP) is the current standard of care in breast reconstruction. The newer Superficial Inferior Epigastric Artery flap (SIEA) is felt to be an improvement ...

Detailed Description

A blinded, randomized, prospective clinical trial is being performed involving Manitoban women over 18 years undergoing unilateral or bilateral breast reconstruction. Women were originally randomized ...

Eligibility Criteria

Inclusion

  • female subject older than 18
  • with satisfactory abdominal tissue for DIEP and SIEA flap reconstruction
  • fluent in English

Exclusion

  • reconstruction planned using latissimus dorsi flap, gluteal artery perforator flap or tissue expansion
  • suffer from neurological back problems
  • suffer form inguinal hernias

Key Trial Info

Start Date :

February 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2016

Estimated Enrollment :

91 Patients enrolled

Trial Details

Trial ID

NCT01469494

Start Date

February 1 2012

End Date

December 1 2016

Last Update

November 6 2018

Active Locations (1)

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Health Sciences Centre

Winnipeg, Manitoba, Canada, R3A 149