Mastectomy
Conditions
Brief summary
The goal of this study is to develop clinical decision-support algorithms for designing participants-specific breast molds for tissue shaping. Autologous breast reconstruction is an important part of breast cancer rehabilitation for many participants. Our goal is to increase the efficiency of autologous breast reconstruction by helping the surgeon design participants-specific molds for shaping tissue into an acceptable breast form.
Detailed description
Primary Objective: To evaluate the efficiency of autologous reconstruction performed with 3D-printed participants-specific breast molds designed using our clinical decision-support algorithms. Secondary Objectives: To assess the total number of times the mold was used by the surgeons in the intervention group. To compare the intraoperative time for shaping tissue in control versus intervention group. To collect information on the type of revisions for aesthetic purposes required in control versus intervention group. To assess the number and type of complications experienced in control versus intervention group.
Interventions
PROCEDUREStandard of care reconstruction
Participants will receive standard of care reconstruction
PROCEDURESurgery, Breast Mold
Participants will undergo surgery. The surgeon may utilize the custom breast mold in shaping the autologous tissue flap for particiapnts.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse eEents (AEs) | Through study completion; an average of 1 year. | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTAshleigh M Francis, MD
PRINCIPAL_INVESTIGATORAshleigh M Francis, MD
M.D. Anderson Cancer Center
Outcome results
None listed