Acellular Dermal Matrix Investigation in Breast Reconstruction

Breast Reconstruction Clinical Trial

— ADMIRE  

Official title:

Acellular Dermal Matrix Investigation in Breast Reconstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456554
• Other study ID #: RTI-CL-5000
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: RTI Surgical
• Contact: Leah Johnson
• Phone: 952-393-2831
• Email: leah.johnson[@]brightresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 467
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years and older

Eligibility

Inclusion 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

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

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Device:
• Acellular Dermal Matrix (Cortiva Tissue Matrix)
non-crosslinked dermis

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
RTI Surgical	Bright Research Partners, MCRA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of major adverse events	Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study	12 months
Primary	Health related quality of life	Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being	12 months
Secondary	Change in quality of life	Change from baseline in quality of life as measured by the BREAST-Q	1 year and 2 years
Secondary	Procedure related adverse events	Rate of procedure-related adverse events requiring additional treatment	3 months, 1 year and 2 years
Secondary	Investigational device related adverse events	Rate of investigational device-related adverse events requiring additional treatment	3 months, 1 year and 2 years
Secondary	Histopathology assessment	Histopathology assessment at stage 2 procedure	stage 2 procedure