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

Phase 3

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM); Procedure: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)

• Registration Number: NCT05316324
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-23
• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 353

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prepectoral Breast Reconstruction without ADM	Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)	-
Prepectoral Breast Reconstruction with ADM	Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients who experience major complications	90 days	Listed below are definitions for 90-day major complications for TEs (i.e., infection, explantation, and reoperation for any cause, including mastectomy flap necrosis): * Infection defined as: * Any event requiring the restart of antibiotics (oral or intravenous) after completion of initial perioperative antibiotics; * Admission to the hospital for signs and symptoms of cellulitis (redness on breast mound) requiring antibiotics; * Purulent drainage from the surgical site or incision; * Explantation defined as the need for removal of a TE for any cause; * Reoperation defined as skin excision performed in either the clinic or the operating room for mastectomy skin flap necrosis, surgical incision dehiscence, pending skin breakdown or another surgical complication

Secondary Outcome Measures

Name	Time	Method
Estimate rates of minor complications (specifically seroma)	90 days	Minor complication for (Tissue Expanders) TEs are defined as: o Seroma: Clinically significant noninfected fluid collection requiring either needle aspiration or drain replacement

Trial Locations

Locations (2)

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