Patient-specific 3D-printed breast molds for shaping tissue during autologous reconstruction

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

Surgeons will use clinical decision-support algorithms to design patient-specific breast molds that are produced with 3D printing and used intraoperatively during autologous free-flap reconstruction (DIEP or TRAM). Participants will be enrolled into intervention and control groups to compare outcomes with and without the custom mold. The primary outcome focuses on operative efficiency for tissue shaping, while secondary outcomes include number of mold uses, intraoperative shaping time, aesthetic revision rates, and postoperative complications. Results will inform the practical utility of the algorithms and molds for routine reconstructive practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients 18 years of age or older
2. Patients who are willing and able to provide informed consent
3. Patients who are scheduled to undergo breast reconstruction with free flap (Deep Interior Epigastric Artery Perforator (DIEP) flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap)

Exclusion Criteria:

1. Patients whose surgical plan includes the use of stacked flaps (DIEP + other free flap, usually from the thigh or buttock)
2. Patients whose surgical plan includes the use of DIEP flap with vascularized lymph node transfer
3. Patients undergoing neoadjuvant radiation

Where it's running

• The University of Texas M. D. Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Ashleigh M Francis, MD — M.D. Anderson Cancer Center
• Study coordinator: Ashleigh M Francis, MD
• Email: amfrancis@mdanderson.org
• Phone: 713-563-4598

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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.