Autologous Fat Grafting vs DIEP flap for reconstructed breast after radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this study, researchers compare autologous fat transfer (AFT) with the DIEP flap method for breast reconstruction in irradiated patients post-mastectomy. The trial will look at patient satisfaction, quality of life, complication rates, and cost-effectiveness between the two approaches. Participants can be randomized to receive either AFT or DIEP flap and will be followed to assess non-inferiority in satisfaction at 12 months after final operation, along with safety and oncologic considerations. The investigation aims to determine if AFT offers similar reconstructive outcomes with potentially lower morbidity in this specific population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female, aged \>18 years.
* BMI between \> 22 and \<35 kg/m2
* History of breast cancer treated with mastectomy (minimally 3 months after mastec-tomy) and post mastectomy chest wall radiotherapy (completed ≥6 months before en-rollment).
* May include contralateral/bilateral prophylactic mastectomy if at least one side had cancer and radiation.
* Desires autologous breast reconstruction and accepts randomization between AFT and DIEP.
* Medically fit for surgery (ASA I-III).
* Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature).
* No evidence of active cancer at enrollment; remission confirmed.
* Able to wear the EVE device (if randomized in AFT).
* Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up.

Exclusion Criteria:

* Prior autologous breast reconstruction on the intended side. BMI \<22 or \>35 kg/m2
* Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators).
* Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability).
* Current chemotherapy or completed less than 4 weeks prior to enrollment.
* Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure).
* Active smoker or not abstinent for at least 6 weeks pre-operatively.
* Pregnant at time of enrollment.
* In case low compliance is expected or an inability to comply with study protocol, including unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans).
* Previous enrollment in this trial (patients can only be included once, even if later presenting for contralateral reconstruction).
* Allergy to lidocaine or silicone

Where it's running

• AzM
  Maastricht, Limburg, Netherlands Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.