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

Running, not enrolling · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT05316324

Run by

Memorial Sloan Kettering Cancer Center

People needed

353

Starts

2022-03-23

Expected to finish

2027-03-01

Last updated by the study team

2026-02-17

Who can join

Age: 21 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of radiotherapy to the operative breast
• Current smoker
• Non-English speaking patients
• Planning to undergo direct-to-implant reconstruction
• Prior sternotomy

Where it is running

• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Rockville Centre, New York, United States

Full record on ClinicalTrials.gov

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