Acellular Dermal Matrix Investigation in Breast Reconstruction

Description

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

Conditions

Breast Reconstruction

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Study Overview

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Study Details

Study overview

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

Acellular Dermal Matrix Investigation in Breast Reconstruction

Acellular Dermal Matrix Investigation in Breast Reconstruction

Condition
Breast Reconstruction
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

New York

Columbia University Irving Medical Center/New York Presbyterian Hospital, New York, New York, United States, 10032

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Genetic female
  • * Age 22 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
  • * 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
  • * Is scheduled to undergo post-operative radiation therapy

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

RTI Surgical,

Study Record Dates

2027-12