Status:
ACTIVE_NOT_RECRUITING
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
The Plastic Surgery Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-75 years
Phase:
PHASE3
Brief Summary
The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when A...
Eligibility Criteria
Inclusion
- Females aged 21-60 years
- Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer
- Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage
- Planning to undergo nipple-sparing or skin-sparing mastectomy
- Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion
- Intraoperative confirmation of prepectoral plane viability by operating physician
Exclusion
- History of radiotherapy to the operative breast
- Current smoker
- Non-English speaking patients
- Planning to undergo direct-to-implant reconstruction
- Prior sternotomy
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT05316324
Start Date
March 23 2022
End Date
March 1 2026
Last Update
February 13 2025
Active Locations (2)
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1
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
2
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States, 11553