Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07641985
NA

Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following mastectomy. It will also evaluate patient satisfaction, quality of life, complication rates, and cost-effectiveness of both reconstruction techniques. The main questions it aims to answer are: Does AFT result in non-inferior patient satisfaction with the reconstructed breast compared to DIEP flap reconstruction 12 months after the final operation? Does AFT result in fewer major complications and improved cost-effectiveness compared to DIEP flap reconstruction? Are quality of life outcomes and oncologic safety comparable between AFT and DIEP flap reconstruction in irradiated patients? Researchers will compare AFT to DIEP flap reconstruction to see if AFT can provide similar reconstructive outcomes with lower morbidity and fewer complications in irradiated breast cancer patients. Participants will: Undergo breast reconstruction using either AFT or DIEP flap reconstruction Attend follow-up visits for clinical examinations, imaging, and assessment of complications Complete questionnaires about breast satisfaction, quality of life, and recovery during follow-up Be monitored for oncologic safety and reconstructive outcomes for 12 months after the final operation

Official title: Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Patients

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2026-07-01

Completion Date

2032-07-01

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

PROCEDURE

Autologous fat transfer

Autologous fat transfer as total breast reconstruction

PROCEDURE

Deep inferior epigastric perforator flap

Deep inferior epigastric perforator flap as breast reconstruction

Locations (1)

AzM

Maastricht, Limburg, Netherlands