Acellular Dermal Matrix Investigation in Breast Reconstruction (ADMIRE)

April 29, 2026 updated by: RTI Surgical
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

467

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center
        • Contact:
          • Shalini Shah
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Principal Investigator:
          • Christodoulos Kaoutzanis, MD
        • Contact:
    • Kansas
      • Lawrence, Kansas, United States, 66045
        • Recruiting
        • University of Kansas
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
        • Principal Investigator:
          • Trina Ebersole, MD
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Michael Curtis, MD
    • New York
      • New York, New York, United States, 10032
      • New York, New York, United States, 10016
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Risal Djohan, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Not yet recruiting
        • Mercy Hospital
        • Contact:
          • Maryann Martinovic, MD
      • Oklahoma City, Oklahoma, United States, 73120
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI Surgical

Collaborators

MCRA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • RTI-CL-5000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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