Evaluation of the BREAST-II Trial for Total Breast Reconstruction Solely Using Autologous Fat Transfer: 1-Year Follow-Up.
Wessel B W van der Venne, Kyrah S Goeree, Jamilla L M Wederfoort...
https://pubmed.ncbi.nlm.nih.gov/41568954Actively Recruiting
Age: 18Years +
FEMALE
ID04261829
Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method
Led by Maastricht University Medical Center · Updated on 2021-07-29
350
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are monitoring the effectiveness and safety of Autologous Fat Transfer (AFT) with pre-expansion as a method for full breast reconstruction in female breast cancer patients. This multicenter, prospective cohort study follows the BREAST trial and aims to evaluate quality of life, aesthetic outcomes, complications, oncological safety, and cost-effectiveness of AFT. All participants will receive AFT in this observational study. Participants will undergo breast reconstruction using Autologous Fat Transfer combined with an external expansion device. This procedure is offered to women who have had or will have a mastectomy, including preventive mastectomy. The study focuses on assessing various outcomes over several years, with particular attention to quality of life and aesthetic results at two years, and oncological safety up to five years after treatment. During the study, participants will be monitored for breast-related quality of life, aesthetic results, any complications, oncological safety, and the cost-effectiveness of the procedure. These outcomes will be assessed through regular follow-ups and evaluations over a period of two to five years. The study is led by Maastricht University Medical Center and aims to provide comprehensive information on this breast reconstruction method.
CONDITIONS
Brief Title
AFT: Introduction of a Full Breast Reconstructive Method
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female gender
- Age of 18 years and older
- History or candidate for a mastectomy procedure in the near future
- Patients undergoing preventive mastectomy
- Patients choosing to have breast reconstruction
- Willing to participate in this study
- Able to wear the external expansion device
You will not qualify if you...
- Active smoker or history of smoking within 4 weeks before surgery
- Current substance abuse
- Allergy to lidocaine
- Allergy to silicone
- Less than 4 weeks since chemotherapy
- History of radiation therapy to the breast area
- Planned radiotherapy after mastectomy
- Kidney disease
- Steroid-dependent asthma or other related diseases
- Immune-suppressed or compromised condition
- Uncontrolled diabetes
- Body mass index over 30
- Large breast size (larger than cup C), unless preferring reduction of the other breast to cup C
- Silicone leakage from previous breast implant
- Strong doubts from plastic surgeon about treatment compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Duration varies depending on reconstruction process
Participants who choose to have breast reconstruction undergo Autologous Fat Transfer combined with external expansion.
Multiple visits as required for fat transfer and external expansion procedures
Long-term Monitoring
Duration - Up to 5 years
Participants are observed for breast-related quality of life, aesthetic results, complications, oncological safety, and cost-effectiveness.
Follow-up visits scheduled over 2 to 5 years depending on outcomes monitored
Trial Site Locations
Total: 8 locations
1
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6229 HX
Enrolling by Invitation
2
Viecuri Venlo
Venlo, Limburg, Netherlands
Actively Recruiting
3
Amsterdam University Medical Center (VUMC)
Amsterdam, Netherlands
Enrolling by Invitation
4
Rijnstate
Arnhem, Netherlands
Enrolling by Invitation
5
Alexander Monro, Bilthoven
Bilthoven, Netherlands
Enrolling by Invitation
6
Amphia
Breda, Netherlands
Enrolling by Invitation
7
Ziekenhuis groep Twente (ZGT)
Hengelo, Netherlands
Actively Recruiting
8
Medical Center Leeuwarden
Leeuwarden, Netherlands
Actively Recruiting
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Research Team
J
Jamilla Wederfoort, MD, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
The Learning Curve of Total Breast Reconstruction With Autologous Fat Transfer.
Maud Rijkx, Alexander Saelmans, Juliette Hommes...
https://pubmed.ncbi.nlm.nih.gov/39016317