Breast Cancer Clinical Trial

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

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 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

History of radiotherapy
Current smoker
Non-English speaking patients
Planning to undergo direct-to-implant reconstruction
BMI >35
Prior sternotomy

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

352

Study ID:

NCT05316324

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York New York, 10065, United States More Info
Evan Matros, MD
Contact
646-608-8044
Jonas Nelson, MD
Contact
646-608-8040

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

352

Study ID:

NCT05316324

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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