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Alloplastic Implant

ADMs for Breast Reconstruction (Breast_ADM Trial)

N/A
Recruiting
Led By Dr. Nancy Van Laeken
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All woman aged 21 years or older but less that 65 undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using ADM
Be older than 18 years old
Must not have
Patients with prior radiation treatment to the breast or with prior mantle radiation
Patients undergoing an axillary node dissection with clearance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 month of stage ii procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the surgical outcomes of 4 different acellular dermal matrices (ADMs) for primary breast reconstruction over 2 years. It will compare the complications and post-op care of the different ADMs.

Who is the study for?
Women aged 21-65 who are undergoing breast reconstruction with tissue expanders and ADMs after a mastectomy can join. They must be having the procedure in two stages and have not had previous breast reconstructions, radiation to the chest, or axillary node dissection. Those allergic to certain antibiotics (Gentamicin, Vancomycin) or Polysporin's ingredients cannot participate.
What is being tested?
The trial is testing four different acellular dermal matrices (ADMs): AlloDerm, DermaCell, Allomax, and Flex HD used during breast reconstruction surgery. It aims to find out which one has fewer complications by tracking patients' recovery over two years.
What are the potential side effects?
Potential side effects from using ADMs may include infection at the surgery site, inflammation of the reconstructed area, reaction to materials in the ADMs like skin irritation or allergy symptoms if sensitive to components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 21-65 planning to have breast reconstruction with synthetic materials.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had radiation treatment to my breast or upper chest before.
Select...
I am having surgery to remove lymph nodes under my arm.
Select...
I have had breast reconstruction surgery before.
Select...
I cannot have breast reconstruction due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 month of stage i surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 month of stage i surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Seroma incidence
Secondary study objectives
ADM integration assessment
Capsular contracture incidence
Hematoma incidence
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: Flex HD groupActive Control1 Intervention
Device for immediate implant based breast reconstruction.
Group II: DermACELL groupActive Control1 Intervention
Device for immediate implant based breast reconstruction.
Group III: AlloDerm groupActive Control1 Intervention
Device for immediate implant based breast reconstruction.
Group IV: AlloMax groupActive Control1 Intervention
Device for immediate implant based breast reconstruction.

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,481 Previous Clinical Trials
2,494,588 Total Patients Enrolled
2 Trials studying Breast Reconstruction
752 Patients Enrolled for Breast Reconstruction
Dr. Nancy Van LaekenPrincipal InvestigatorUniversity of British Columbia

Media Library

AlloDerm (Alloplastic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04661501 — N/A
Breast Reconstruction Research Study Groups: Flex HD group, DermACELL group, AlloDerm group, AlloMax group
Breast Reconstruction Clinical Trial 2023: AlloDerm Highlights & Side Effects. Trial Name: NCT04661501 — N/A
AlloDerm (Alloplastic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04661501 — N/A
~59 spots leftby Dec 2025
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