Acellular Dermal Matrix Investigation in Breast Reconstruction (ADMIRE)

RTI Surgical

Status: Enrolling

Conditions: Breast Reconstruction

Treatments: Device: Acellular Dermal Matrix (Cortiva Tissue Matrix)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06456554

RTI-CL-5000

Details and patient eligibility

About

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

Enrollment: 467 estimated patients

Sex: Female

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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467 participants in 2 patient groups

Acellular Dermal Matrix

Experimental group

Description:

Breast reconstruction with Cortiva Tissue Matrix

Treatment:

Device: Acellular Dermal Matrix (Cortiva Tissue Matrix)

no Acellular Dermal Matrix

No Intervention group

Description:

Breast reconstruction only with no ADM