AFT: Introduction of a Full Breast Reconstructive Method

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-09

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Reconstructive Surgery Breast Reconstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Autologous Fat Transfer

Intervention Type PROCEDURE

Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.

Interventions

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Autologous Fat Transfer

Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.

Intervention Type PROCEDURE

Other Intervention Names

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Lipofilling

Eligibility Criteria

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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 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 of the contralateral side towards Cup C
* Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction
* The treating plastic surgeon has strong doubts on the patient's treatment compliance

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrzej Piatkowski de Grzymala, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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