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Corticosteroid
Acellular Dermal Matrix for Breast Reconstruction (ADMIRE Trial)
N/A
Recruiting
Research Sponsored by RTI Surgical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing and capable of providing informed consent
Genetic female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year and 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is a study at multiple centers that will involve female participants undergoing a two-stage breast reconstruction using a specific technique.
Who is the study for?
This trial is for genetic females aged 22 or older who are planning to have immediate breast reconstruction using a two-stage, pre-pectoral technique after nipple or skin sparing mastectomy. Participants must be willing and able to give informed consent and follow the study's requirements.
What is being tested?
The study is testing Acellular Dermal Matrix (Cortiva Tissue Matrix) in women undergoing breast reconstruction. It's a prospective, multi-center clinical study with two non-randomized groups comparing outcomes of this specific surgical technique.
What are the potential side effects?
While not explicitly listed here, side effects may include typical risks associated with surgical implantation such as infection, inflammation at the surgery site, pain, possible rejection of the matrix material, and complications related to wound healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing and able to agree to the study's procedures.
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I am genetically female.
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I am having or have had a mastectomy saving the nipple or skin.
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I am 22 years old or older.
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I am having breast reconstruction right after my mastectomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year and 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Health related quality of life
Rate of major adverse events
Secondary study objectives
Change in quality of life
Histopathology assessment
Investigational device related adverse events
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Acellular Dermal MatrixExperimental Treatment1 Intervention
Breast reconstruction with Cortiva Tissue Matrix
Group II: no Acellular Dermal MatrixActive Control1 Intervention
Breast reconstruction only with no ADM
Find a Location
Who is running the clinical trial?
Bright Research PartnersIndustry Sponsor
17 Previous Clinical Trials
2,210 Total Patients Enrolled
RTI SurgicalLead Sponsor
17 Previous Clinical Trials
5,995 Total Patients Enrolled
1 Trials studying Breast Reconstruction
87 Patients Enrolled for Breast Reconstruction
MCRAIndustry Sponsor
36 Previous Clinical Trials
9,580 Total Patients Enrolled