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NCT Number: NCT05744414

Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries

This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix.

AlloMend® Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen will be studied.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Implant; Complications, Infection or Inflammation Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Janiga MDs Plastic Surgery and Cosmetic Center

Reno, Nevada, 89521, United States

About this study

The purpose of this study is to evaluate the incorporation of AlloMend® Acellular Dermal Matrix with native surrounding tissue by obtaining up to three, 1 cm diameter biopsies per breast. The samples will then be transported to AlloSource Research and Development Labs for slide preparation and histologic analysis.

This study will be performed at one (1) clinical center in the United States.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ≥18 years of age;
  • AlloMend® Acellular Dermal Matrix used during the initial prepectoral placement of tissue expanders for breast reconstruction;
  • Is scheduled or will be scheduled for a procedure to exchange the tissue expander for permanent breast implant;
  • Can understand the requirements of the study, has provided written, informed consent, and to comply with the study protocol.

Exclusion criteria

  • Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to consent to participate in the clinical study;
  • Subjects who, in the opinion of the investigator, would not be able or willing to comply with the protocol.

Treatment and study plan

Primary outcomes

  1. AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application

    Time frame: At expander/implant exchange surgery; typically 1-3 months post expander placement

    The primary endpoint being evaluated in this study is AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application. The endpoint will be analyzed from biopsied tissue samples taken during the exchange of expander to permanent breast implant using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen.

Secondary outcomes

  1. Infection rates

    Time frame: Up to 6 months post expander/implant exchange

    Information collected through clinical standard of care

  2. Seroma rates

    Time frame: Up to 6 months post expander/implant exchange

    Information collected through clinical standard of care

  3. Hematoma rates

    Time frame: Up to 6 months post expander/implant exchange

    Information collected through clinical standard of care

  4. Drain outputs and timing of drain removal

    Time frame: Up to 6 months post expander/implant exchange

    Information collected through clinical standard of care

  5. Revision surgeries

    Time frame: Up to 6 months post expander/implant exchange

    Information collected through clinical standard of care

Sponsors and collaborators

Lead sponsor

AlloSource

Industry

Registry information

Official study title

Histological Analysis of AlloMend® Acellular Dermal Matrix Used During the Initial Pre Pectoral Placement of Tissue Expanders for Breast Reconstruction and Evaluated at Time of Permanent Breast Implantation

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2023
Registry last updated
Nov 21, 2025

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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