← Back to Search

Acellular Dermal Matrix

Mesh Reconstruction for Breast Cancer

N/A
Recruiting
Led By Michael Delong, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders
Be older than 18 years old
Must not have
Direct-to-implant reconstruction
Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the use of surgical mesh in pre-pectoral tissue expander to breast implant reconstruction.

Who is the study for?
This trial is for women aged 22-75 who are undergoing immediate breast reconstruction with tissue expanders after a mastectomy due to cancer or as a preventive measure. It's open to those having the implant placed above the chest muscle and can be for one or both breasts. Women who are pregnant, have poor skin conditions post-mastectomy, or plan on direct-to-implant or mixed reconstruction methods cannot participate.
What is being tested?
The study is testing if using surgical mesh (ADM) helps in breast reconstruction when implants are placed over the chest muscle. This randomized trial will compare outcomes of reconstructions done with ADM assistance against those without it, aiming to provide evidence about their effectiveness and safety.
What are the potential side effects?
Potential side effects may include inflammation around the breast area, infection risks associated with implants and surgery, complications from mesh such as rejection or adverse reactions, but specific side effect profiles will be studied during this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 22-75 planning immediate breast reconstruction with tissue expanders.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am having breast reconstruction with an implant in one surgery.
Select...
My surgery showed that immediate reconstruction in front of the chest muscle isn't suitable due to poor skin condition.
Select...
I plan to have reconstruction surgery at a later time.
Select...
I am having both breasts reconstructed, with one being placed under the muscle.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effectiveness - BREASTQ
Safety - Major Complications
Secondary study objectives
Capsular Contracture
Secondary Effectiveness
Secondary Safety

Side effects data

From 2016 Phase 4 trial • 20 Patients • NCT02450383
70%
Early Wound Dehiscence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Experimental

Awards & 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
Patients will receive ADM during their initial tissue expander placement.
Group II: ControlActive Control1 Intervention
Patients will not receive ADM during their initial tissue expander placement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acellular Dermal Matrix
1999
Completed Phase 4
~230

Find a Location

Who is running the clinical trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterOTHER
104 Previous Clinical Trials
46,463 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,562 Previous Clinical Trials
10,262,241 Total Patients Enrolled
University of MichiganOTHER
1,852 Previous Clinical Trials
6,432,622 Total Patients Enrolled

Media Library

Acellular Dermal Matrix (Acellular Dermal Matrix) Clinical Trial Eligibility Overview. Trial Name: NCT05190978 — N/A
Breast Implant Infection or Inflammation Research Study Groups: Control, Acellular Dermal Matrix
Breast Implant Infection or Inflammation Clinical Trial 2023: Acellular Dermal Matrix Highlights & Side Effects. Trial Name: NCT05190978 — N/A
Acellular Dermal Matrix (Acellular Dermal Matrix) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05190978 — N/A
~20 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top