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

A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05316324

Enrollment

353

Registered

2022-04-07

Start date

2022-03-23

Completion date

2027-03-01

Last updated

2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Acellular Dermal Matrix, Breast Reconstruction, Mastectomy, 22-071

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.

Interventions

PROCEDUREPrepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)

Prepectoral Breast Reconstruction with (ADM)

PROCEDUREPrepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)

Prepectoral Breast Reconstruction without ADM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREvan Matros, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026