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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 month of stage ii procedure
Awards & highlights
Breast_ADM Trial 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.Check my eligibility
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.See study design
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.
Breast_ADM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 21-65 planning to have breast reconstruction with synthetic materials.
Breast_ADM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1 month of stage i surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 month of stage i surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Seroma incidence
Secondary outcome measures
ADM integration assessment
Capsular contracture incidence
Hematoma incidence
+11 moreBreast_ADM 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
1,417 Previous Clinical Trials
2,466,750 Total Patients Enrolled
2 Trials studying Breast Reconstruction
752 Patients Enrolled for Breast Reconstruction
Dr. Nancy Van LaekenPrincipal InvestigatorUniversity of British Columbia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgeon might consider me ineligible for breast reconstruction if they find poor blood flow in the breast area during surgery.I am a woman aged 21-65 planning to have breast reconstruction with synthetic materials.I have had radiation treatment to my breast or upper chest before.My breast reconstruction will be in two stages, starting with tissue expanders.I am having surgery to remove lymph nodes under my arm.I have had breast reconstruction surgery before.You are allergic to Polysporin or any of its ingredients.I am planning or have had breast reconstruction using my own tissue.I cannot have breast reconstruction due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Flex HD group
- Group 2: DermACELL group
- Group 3: AlloDerm group
- Group 4: AlloMax group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could adults aged 20+ partake in the research program?
"For eligibility, applicants must be aged between 21 and 65."
Answered by AI
Are additional participants accepted for this investigation?
"The clinical trial is currently recruiting participants, as noted on the information hosted at clinicaltrials.gov - this study was first posted November 25th 2020 and has been updated most recently May 27th 2023."
Answered by AI
Could I be considered a candidate for this medical experiment?
"Qualifying individuals for this medical trial must have undergone breast reconstruction, and be between 21 to 65 years old. Approximately 328 patients are being taken on board."
Answered by AI
How many individuals have signed up to participate in this experiment?
"Yes, the clinicaltrials.gov website reveals that this research endeavour is still in need of participants. This trial was posted on November 25th 2020 and last edited May 27th 2023; it aims to enroll 328 patients across 4 different sites."
Answered by AI
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