Preliminary investigation of the safety of volumetric bioabsorable scaffold with delayed vital autologous fat graft for post-mastectomy patients

Becton Dickinson Pty Ltd0 个研究点目标入组 20 人开始时间: 2022年5月27日最近更新: 2022年6月6日

试验速览

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•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

•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.

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