Actively Recruiting
BREAST ADM Trial for Alloplastic Breast Reconstruction
Led by University of British Columbia · Updated on 2024-12-16
328
Participants Needed
4
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized single blinded prospective clinical trial comparing the surgical outcomes of four different acellular dermal matrixes (ADMs) after primary breast reconstruction. ADMs are used in conjunction with tissue expanders or breast implants to reinforce the recreated breast pocket. Currently, 4 different ADMS are commercially available: AlloDerm, DermaCell, Allomax and Flex HD. It is unclear which ADM is clinically superior. The objective of the study is to compare the complications and post-op care of 4 different ADMs within a 2 year follow up to elucidate their surgical outcomes.
CONDITIONS
Official Title
BREAST ADM Trial for Alloplastic Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 21 years or older but less than 65
- Undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using acellular dermal matrix (ADM)
- Breast reconstruction must be a two-stage process using tissue expanders and ADM followed by implant exchange
You will not qualify if you...
- Patients undergoing autologous reconstruction at the time of mastectomy or delayed
- History of previous breast reconstruction procedures
- Prior radiation treatment to the breast or mantle radiation
- Any contraindication to breast reconstruction
- Patients undergoing axillary node dissection with clearance
- Allergy to Polysporin or its ingredients
- Allergy to Gentamicin or Vancomycin if receiving DermACELL
- Surgeon deems patient ineligible due to significant mastectomy flap ischemia detected intraoperatively
AI-Screening
AI-Powered Screening
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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
CONTACT
R
Raveena Gowda
CONTACT
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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