Status:
RECRUITING
BREAST ADM Trial for Alloplastic Breast Reconstruction
Lead Sponsor:
University of British Columbia
Conditions:
Breast Reconstruction
Eligibility:
FEMALE
21-65 years
Phase:
NA
Brief Summary
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 us...
Detailed Description
This study is a randomized control trial and will include all patients who are agreeable and deemed appropriate for alloplastic breast reconstruction involving the use of an ADM with two stage tissue ...
Eligibility Criteria
Inclusion
- 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 by implant tissue expander to implant exchange.
Exclusion
- Patients undergoing autologous reconstruction either at the time of mastectomy or in a delayed fashion.
- Patients with a history of previous breast reconstruction procedures.
- Patients with prior radiation treatment to the breast or with prior mantle radiation
- Any patient with a contraindication to breast reconstruction
- Patients undergoing an axillary node dissection with clearance
- Patients with an allergy to Polysporin or any of its ingredients.
- Patients with contraindications to any of the acellular dermal matrices:
- • DermACELL: Allergy to Gentamicin, Vancomycin\[12\]
- The surgeon performing the breast reconstruction may also deem a patient ineligible if intraoperatively, there is evidence of significant mastectomy flap ischemia prior to the initiation of the breast reconstruction procedure.
Key Trial Info
Start Date :
November 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT04661501
Start Date
November 25 2020
End Date
December 31 2025
Last Update
December 16 2024
Active Locations (4)
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1
Mount Saint Joseph's Hospital
Vancouver, British Columbia, Canada, V5T 3N4
2
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
3
UBC Hospital
Vancouver, British Columbia, Canada, V6T 1Z7
4
Saint Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6