Acellular Dermal Matrix Investigation in Breast Reconstruction

Purpose

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

Condition

  • Breast Reconstruction

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Acellular Dermal Matrix 		Breast reconstruction with Cortiva Tissue Matrix
  • Device: Acellular Dermal Matrix (Cortiva Tissue Matrix)
    non-crosslinked dermis
No Intervention
no Acellular Dermal Matrix 		Breast reconstruction only with no ADM

Recruiting Locations

University of Kansas
Lawrence, Kansas 66045
Contact:
Jessica Reynolds
619-753-2866
jreynolds11@kumc.edu

More Details

Status
Recruiting
Sponsor
RTI Surgical

Study Contact

Ana Villagomez
202-552-6013
avillagomez@mcra.com