RecruitingNot ApplicableNCT06456554

Acellular Dermal Matrix Investigation in Breast Reconstruction

Sponsor

RTI Surgical

Enrollment

467 participants

Start Date

Nov 22, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Reconstruction

Summary

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

Eligibility

Sex: FEMALEMin Age: 22 Years

Inclusion Criteria7

Genetic female
Age 22 or older at time of consent
Undergoing immediate breast reconstruction
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

Exclusion Criteria14

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
Active abscess or infection in the intended reconstruction site
Residual gross tumor at the intended reconstruction site
Active use of any tobacco/nicotine products
Has body mass index (BMI) \>35
Uncontrolled diabetes defined as HbA1c ≥7 within 3 months prior to stage 1 procedure
Is currently taking medications including systemic steroids