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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer

Treatments: Procedure: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM); Procedure: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)

Study type: Interventional

Funder types: Other

Identifiers

NCT05316324

22-071

Details and patient eligibility

About

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.

Enrollment: 352 estimated patients

Sex: Female

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

352 participants in 2 patient groups

Prepectoral Breast Reconstruction with ADM

Experimental group

Treatment:

Procedure: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)

Prepectoral Breast Reconstruction without ADM

Experimental group

Treatment:

Procedure: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)