Who is eligible for clinical trial NCT05316324?

Participants must meet protocol criteria for Breast Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05316324 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-02-13

A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction (NCT05316324)

🔵 Active, Not Recruiting Phase3 🩺 Clinical Procedure Protocol Sponsor: Memorial Sloan Kettering Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (6 items).

Location: Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗