Actively Recruiting
Acellular Dermal Matrix Investigation in Breast Reconstruction
Led by RTI Surgical · Updated on 2026-04-30
467
Participants Needed
13
Research Sites
157 weeks
Total Duration
On this page
Sponsors
R
RTI Surgical
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
CONDITIONS
Official Title
Acellular Dermal Matrix Investigation in Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Genetic female
- Age 22 or older at time of consent
- Undergoing immediate breast reconstruction
- Two-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
You will not qualify if you...
- Planned concurrent reconstruction with pedicled flaps or free tissue
- Pregnant or breastfeeding
- Tissue unsuitable for two-stage breast reconstruction as determined by investigator
- History of psychological traits incompatible with surgery and prosthesis
- Serious or unstable medical disorders interfering with safety, consent, or compliance
- Vulnerable subject populations
- Current participation in conflicting clinical trials
- Prior neoadjuvant radiotherapy to reconstruction site or chest wall
- Active abscess or infection at reconstruction site
- Residual gross tumor at reconstruction site
- Active use of tobacco or nicotine products
- Body mass index over 35
- Uncontrolled diabetes with HbA1c ≥7 within 3 months before stage 1 procedure
- Currently taking systemic steroids or similar medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University of Arkansas
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
University of Kansas
Lawrence, Kansas, United States, 66045
Actively Recruiting
5
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
6
Mercy Hospital
St Louis, Missouri, United States, 63141
Actively Recruiting
7
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
8
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
9
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
10
Mercy Hospital
Oklahoma City, Oklahoma, United States, 73120
Not Yet Recruiting
11
Mercy
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
12
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Ana Villagomez
CONTACT
P
Paul Bonvallet, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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