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OpenTrials
Active, Not Recruiting

NCT Number: NCT05316324

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)

Procedure

Prepectoral Breast Reconstruction with (ADM)

Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)

Procedure

Prepectoral Breast Reconstruction without ADM

Primary outcomes

  1. Percentage of patients who experience major complications

    Time frame: 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 outcomes

  1. Estimate rates of minor complications (specifically seroma)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • The Plastic Surgery Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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