AFT: Introduction of a Full Breast Reconstructive Method

Last updated: July 22, 2021
Sponsor: Maastricht University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Breast Reconstruction

Cancer

Treatment

N/A

Clinical Study ID

NCT04261829
NL72808.068.20
  • Ages > 18
  • Female

Study Summary

A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female gender
  • Age of 18 years and older
  • History or in candidate for a mastectomy procedure in the near future
  • Patients undergoing preventive mastectomy
  • Patients' choice to undergo a breast reconstruction
  • Wanting to participate in this study
  • Patient is able to wear the external expansion device

Exclusion

Exclusion Criteria:

  • Active smoker or a history of smoking 4 weeks prior to surgery
  • Current substance abuse
  • History of lidocaine allergy
  • History of silicone allergy
  • 4 weeks or less after chemotherapy
  • History of radiation therapy in the breast region
  • Oncological treatment includes radiotherapy after mastectomy
  • Kidney disease
  • Steroid dependent asthma (daily or weekly) or other diseases
  • Immune-suppressed or compromised disease
  • Uncontrolled diabetes
  • BMI>30
  • Large breast size (i.e. larger than cup C), unless the patient prefers reduction ofthe contralateral side towards Cup C
  • Extra-capsular silicone leaking from the encapsulated implant from a previous breastreconstruction
  • The treating plastic surgeon has strong doubts on the patient's treatment compliance

Study Design

Total Participants: 350
Study Start date:
December 09, 2020
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Maastricht University Medical Center+

    Maastricht, Limburg 6229 HX
    Netherlands

    Site Not Available

  • Viecuri Venlo

    Venlo, Limburg
    Netherlands

    Active - Recruiting

  • Amsterdam University Medical Center (VUMC)

    Amsterdam,
    Netherlands

    Site Not Available

  • Rijnstate

    Arnhem,
    Netherlands

    Site Not Available

  • Alexander Monro, Bilthoven

    Bilthoven,
    Netherlands

    Site Not Available

  • Amphia

    Breda,
    Netherlands

    Site Not Available

  • Ziekenhuis groep Twente (ZGT)

    Hengelo,
    Netherlands

    Active - Recruiting

  • Medical Center Leeuwarden

    Leeuwarden,
    Netherlands

    Active - Recruiting

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