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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effectiveness - BREASTQ

Safety - Major Complications

Secondary outcome measures

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%

Study treatment Arm

Control

Experimental

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterOTHER

101 Previous Clinical Trials

46,181 Total Patients Enrolled

University of California, Los AngelesLead Sponsor

1,528 Previous Clinical Trials

10,276,731 Total Patients Enrolled

8 Trials studying Breast Cancer

1,552 Patients Enrolled for Breast Cancer

University of MichiganOTHER

1,795 Previous Clinical Trials

6,373,816 Total Patients Enrolled

26 Trials studying Breast Cancer

17,219 Patients Enrolled for Breast Cancer

Media Library

Acellular Dermal Matrix (Acellular Dermal Matrix) Clinical Trial Eligibility Overview. Trial Name: NCT05190978 — N/A

Breast Cancer Research Study Groups: Control, Acellular Dermal Matrix

Breast Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I join this research endeavor?

"This ongoing medical trial is searching for 120 breast cancer patients between the ages of 22 and 75."

Answered by AI

Are there any vacancies remaining for those wishing to enroll in this trial?

"Affirmative, clinicaltrials.gov conveys that this trial is recruiting participants. The original post was on October 1st 2022 and the study has been updated more recently as of September 13th 2022. There are 120 open spots at one location for this medical experiment."

Answered by AI

What is the upper threshold of participants in this trial?

"Affirmative. According to clinicaltrials.gov, this research project is still recruiting participants. The trial was initially published on October 1st 2022 and most recently updated on September 13th 2022. 120 individuals are being sought from a single medical site for the study's purposes."

Answered by AI

Is eligibility restricted to individuals aged 50 or younger for this trial?

"This trial requires participants between the ages of 22 to 75. If your age falls outside this range, there are 79 trials for young adults and 1598 studies suitable for seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Michael R. Delong 2022. "Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05190978.

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