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Acellular Dermal Matrix Investigation in Breast Reconstruction

RecruitingHealthy volunteers welcome

Who can join

Ages 22 and older · Women · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the study

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

What is being tested

Sponsor: RTI Surgical · Participants: 467 · Started: Nov 22, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06456554

Locations in the U.S.

ArkansasUniversity of Arkansas, Little Rock
CaliforniaCity of Hope National Medical Center, Duarte
ColoradoUniversity of Colorado, Aurora
KansasUniversity of Kansas, Lawrence
MissouriMercy Hospital, St Louis
Washington University, St Louis
New YorkNYU Langone Health, New York
New York Presbyterian Hospital/Columbia University Irving Medical Center, New York
OhioCleveland Clinic, Cleveland
OklahomaMercy, Oklahoma City
Mercy Hospital, Oklahoma City (Not yet recruiting)
PennsylvaniaUniversity of Pennsylvania, Philadelphia
TexasMD Anderson, Houston

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.