None listed
Conditions
Brief summary
Mastectomy (breast removal) and reconstruction surgery is a common treatment and preventative measure for women who have or are at risk of developing breast cancer. Reconstruction of the breast using artificial implants is common but not without risks. This study aims to investigate the safety of a novel 3D bio-scaffold device that can be implanted together with the patient's own fat tissue for reconstruction of the breast post-mastectomy. Who is it for? You may be eligible for this study if you are an adult woman aged between 22 and 69 years of age who is scheduled to undergo a mastectomy and breast reconstruction surgery either for confirmed breast cancer, or as a precautionary measure for the prevention of breast cancer. Study details All participants who choose to enroll in this study will undergo a mastectomy (breast removal) and reconstruction surgery. During the reconstruction surgery, rather than inserting an implant the surgeon will insert a 3D bio-scaffold that is designed to give shape to the breast. After an initial month of recovery, fat from other regions of the body will be transplanted to the scaffold to create the breast shape. It is anticipated that the bio-scaffold will absorb into the body over the 12-18 months post-surgery. All participants will be asked to complete a series of questionnaires at yearly intervals for up to 5 years post-surgery. These are anticipated to take no more than 20 minutes at each yearly interval. It is hoped this research will contribute to the process development of new interventions to help other women facing breast reconstruction after breast loss. Participants may also benefit from an overall improved self-assessment of their body image as liposuction from areas with excess fat is needed for redistribution to their breast mound.
Interventions
The investigational device is a three-dimensional dome made from poly-4-hydroxybutyrate (P4HB). This 3-D P4HB Scaffold has been developed for use in breast reconstruction. Typical mastectomy and reconstruction surgery takes up to 3 hours per breast with silicone, saline, or tissue expanders. The use of the Scaffold will take less time than it takes to place a silicone implant, saline implant, or tissue expander. Implanting the Scaffold would be significantly shorter than an autologous breast re
The investigational device is a three-dimensional dome made from poly-4-hydroxybutyrate (P4HB). This 3-D P4HB Scaffold has been developed for use in breast reconstruction. Typical mastectomy and reconstruction surgery takes up to 3 hours per breast with silicone, saline, or tissue expanders. The use of the Scaffold will take less time than it takes to place a silicone implant, saline implant, or tissue expander. Implanting the Scaffold would be significantly shorter than an autologous breast reconstruction which may require over 7 hours of surgery. Surgeons will be trained several weeks prior to the first implantation of the Scaffold. The training is not complex compared to typical reconstruction. The operative reports and clinical elements will be monitored to ensure adherence to the appropriate treatment. 100% of the information collected in the study will be monitored. This dome, or Scaffold, is fully absorbable over 12 to 18 months and meant to be implanted immediately following a mastectomy. Autologous fat transfer [AFT] is performed to supplement the volume restoration of the post-mastectomy breast from 1 to 3 times based on the patient's desired outcome.
Sponsors
Becton Dickinson Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
22 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
Participants will be recruited from the existing pool of women seeking surgical breast cancer reconstruction following mastectomy for cancer or cancer prophylaxis by the primary investigator and their colleagues. In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Female (at birth) >21 years and <70 of age 2. Participants with planned immediate breast reconstruction post-skin sparing or nipple sparing mastectomy (unilateral or bilateral) for cancer or cancer prophylaxis 3. Willing and able to provide written informed consent 4. Willing and able to comply with the study procedures and follow-up
Exclusion criteria
1. Participant is unwilling to undergo at least 1 AFT procedure after their reconstruction. 2. Participants with triple-negative, inflammatory breast cancer, HER2+, Paget disease of the breast, node positive disease, or T-3 tumors. 3. Participants requiring pre or post-mastectomy chemotherapy or radiation therapy. 4. Participants with pathology positive margins and any patient scheduled for radiation therapy upon definitive pathology. 5. Known allergy to tetracycline hydrochloride and kanamycin sulfate (when found after production of P4HB, these antibiotic quantities presented as < 0.1ppm for tetracycline and < 0.1ppm for kanamycin. They are not always able to be detected). 6. Has undergone prior chest radiation treatment. 7. Participants that are Nx preoperative and have positive sentinel node on frozen section at mastectomy. 8. Patients undergoing an axillary node dissection. 9. Has received neoadjuvant chemotherapy within the last 12 months. 10. The surgeon performing the breast reconstruction may also deem a patient ineligible if intraoperatively there is evidence of significant mastectomy flap ischemia prior to the initiation of the breast reconstruction procedure as evaluated clinically or with the SPY fluorescence imaging system (Stryker Corporation, Kalamazoo, MI USA) or other perfusion assessment.
Outcome results
None listed