Acellular Dermal Matrix Investigation in Breast Reconstruction

Not Applicable

Recruiting

• Conditions: Breast Reconstruction

• Registration Number: NCT06456554
• Lead Sponsor: RTI Surgical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-13
• Study Start: 2024-11-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 467

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health related quality of life	12 months	Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being
Rate of major adverse events	12 months	Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study

Secondary Outcome Measures

Name	Time	Method
Histopathology assessment	stage 2 procedure	Histopathology assessment at stage 2 procedure
Investigational device related adverse events	3 months, 1 year and 2 years	Rate of investigational device-related adverse events requiring additional treatment
Change in quality of life	1 year and 2 years	Change from baseline in quality of life as measured by the BREAST-Q
Procedure related adverse events	3 months, 1 year and 2 years	Rate of procedure-related adverse events requiring additional treatment

Trial Locations

Locations (6)

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center/New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States