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A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction

StatusActive, Not Recruiting
PhasePhase 3
Started2022-03-23
View on ClinicalTrials.gov ↗

Amendment history

2026-02-13
Study Status v8
Primary completion date2026-03→2027-03
Completion date2026-03→2027-03
2025-02-12
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 352→confirmed 353
Study sitesdetails revised at 2 of 2 sites
2024-04-01
Study Status v6
Primary completion date2024-03→2026-03
Completion date2024-03→2026-03
2023-07-26
Study Status v5
Re-verified, no change to tracked fields
2023-04-26
Study Status, Eligibility v4
Eligibility criteria-8 characters
[...] tients Planning to undergo direct-to-implant reconstruction BMI >35 Prior sternotomy
Show 3 earlier versions
2023-02-22
Study Status, Contacts/Locations v3
Study sites1→2
2022-11-30
Study Status, Eligibility v2
Eligibility criteria+24 characters
[...] rating physician Exclusion Criteria: History of radiotherapy to the operative breast Current smoker Non-English speaking patients Planning to un [...]
2022-07-06
Study Status, Eligibility v1
Eligibility criteria-108 characters
[...] anning to undergo nipple-sparing or skin-sparing mastectomy Mastectomy weight <800 g per breast/side Adequate mastectomy skin perfusion or adequate perfusion but [...] cm) at the defect margins with otherwise adequate perfusion Intraoperative confirmation of prepectoral plane viability by operating physician Exclusion Criteria: Receipt of neoadjuvant chemotherapy Planned adjuvant radiation therapy Presence of preoperative axillary lymph node metastasis Presence of intraoperative sentinel node positivity History of radiotherapy Current smoker Non-English speaking patients Planning to undergo direct-to [...]
2022-03-30
Original filing
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 ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.
Trial Details
NCT Number NCT05316324
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: The Plastic Surgery Foundation
Conditions Breast Cancer
Enrollment 353 participants
Start Date 2022-03-23
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-17