BREAST ADM Trial for Alloplastic Breast Reconstruction
Recruiting
N/A
Interventional Study
Breast Reconstruction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 21 – 65
- Sex
- Female
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 328 (estimated)
- Sponsor
- University of British Columbia · Other
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About This Trial
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. I…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* All woman aged 21 years or older but less that 65 undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using ADM.
* Breast reconstruction must be done by means of a two staged process using tissue expanders and ADM based reconstruction followed …
Contacts