RecruitingBreast Reconstruction

Acellular Dermal Matrix Investigation in Breast Reconstruction

Eligible age

22+ yrs

Accepts

Women

Locations

10 states

Healthy volunteers

Yes

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About this study

Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.

Sponsor: RTI Surgical

You may qualify if…

✓ Genetic female
✓ Age 22 or older at time of consent
✓ Undergoing immediate breast reconstruction
✓ 2 stage breast reconstruction using pre pectoral technique
✓ Nipple or skin sparing mastectomy
✓ Willing and capable of providing informed consent
✓ Able to comply with study requirements

You may not qualify if…

✕ Planned concurrent reconstruction with pedicled flaps or free tissue
✕ Pregnant or breast feeding
✕ Investigator has determined tissue is unsuitable for two-stage breast reconstruction
✕ History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis
✕ Any serious and/or unstable pre-existing medical disorder or other conditions that could interfere with the subject's safety, the informed consent process, or compliance with the study protocol, in the opinion of the investigator
✕ Vulnerable subject populations
✕ Currently participating in another clinical trial that would have the potential to interfere or conflict with the treatment, follow-up, or objectives of this study
✕ Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall