Acellular Dermal Matrix Investigation in Breast Reconstruction

Launched by RTI SURGICAL · Jun 12, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a specific method for breast reconstruction using a special material called acellular dermal matrix. This study involves women who are having a two-stage breast reconstruction, which means they will have surgery in two parts. The goal is to see how well this technique works when the reconstruction is done in front of the chest muscle, which is known as the pre-pectoral technique.

To be eligible for this study, participants must be women over the age of 22 who are planning to have immediate breast reconstruction after a mastectomy, specifically with nipple or skin-sparing surgery. They should also be able to give informed consent and follow the study rules. Women who are pregnant, have certain health issues, or are involved in other clinical trials may not be able to participate. If someone joins the study, they can expect to receive care and support throughout the process while contributing to important research that could help improve breast reconstruction techniques in the future.

Gender

FEMALE

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
• • Is scheduled to undergo post-operative radiation therapy