Actively Recruiting
The BREAST Trial: Comparing Complications of Four Acellular Dermal Matrices in Alloplastic Breast Reconstruction
Led by University of British Columbia · Updated on 2024-12-16
328
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating four different acellular dermal matrices (ADMs) used in breast reconstruction after mastectomy. ADMs help support the recreated breast pocket during two-stage tissue expander breast reconstruction. The study aims to compare the surgical outcomes and complications of AlloDerm, DermACELL, AlloMax, and Flex HD over a two-year follow-up to determine which ADM may lead to fewer post-operative issues such as seromas. Participants will be randomly assigned to receive one of the four ADM products during their breast reconstruction surgery. Each group will use the assigned ADM along with tissue expanders followed by implant exchange. For bilateral reconstruction, the same ADM will be used on both sides. This randomized controlled trial will assess differences in complications like seroma formation and other post-operative care measures, initially recruiting 40 patients as a pilot to establish study feasibility. During the study, participants will be monitored for outcomes including incidence of seromas, drain duration and output, hematoma, infections, implant loss, and aesthetic satisfaction. Follow-up will include evaluations up to two years after the second surgical stage. Researchers will collect data through clinical assessments and patient questionnaires to measure surgical results, safety, and satisfaction over this period.
CONDITIONS
Brief Title
BREAST ADM Trial for Alloplastic Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 21 years or older but less than 65
- Undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using acellular dermal matrix
- Breast reconstruction performed via a two-stage process with tissue expanders followed by implant exchange
You will not qualify if you...
- Undergoing autologous breast reconstruction at mastectomy or delayed
- History of previous breast reconstruction procedures
- Prior radiation treatment to the breast or mantle radiation
- Contraindications to breast reconstruction
- Undergoing axillary node dissection with clearance
- Allergy to Polysporin or any of its ingredients
- Allergy to Gentamicin or Vancomycin if receiving DermACELL
- Significant mastectomy flap ischemia detected during surgery as deemed by the surgeon
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo alloplastic breast reconstruction using one of four randomly assigned acellular dermal matrices during a two-stage tissue expander reconstruction.
Surgery and follow-up visits within 6 months after each stage
Duration - Up to 2 years
Participants are monitored for complications and outcomes including seroma incidence, drain duration, infections, and aesthetic assessments after reconstruction.
Follow-up visits over 2 years after the second stage surgery
Trial Site Locations
Total: 4 locations
1
Mount Saint Joseph's Hospital
Vancouver, British Columbia, Canada, V5T 3N4
Actively Recruiting
2
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
3
UBC Hospital
Vancouver, British Columbia, Canada, V6T 1Z7
Actively Recruiting
4
Saint Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
Research Team
D
Dr. Nancy Van Laeken
R
Raveena Gowda
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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