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Completed

NCT Number: NCT04710537

Comparing AlloDerm and DermACELL in Breast Reconstruction

This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator.

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Key information

Conditions

Acellular Dermal Matrix in Breast Reconstruction

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DAVinci Plastic Surgery, Washington D.C., District of Columbia, United States

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About this study

The investigators' study aims to determine if there is a significant difference in postoperative outcomes when using DermACELL or AlloDerm, two acellular dermal matrix products, in breast reconstruction. Patients who are undergoing bilateral mastectomies with tissue expanders and acellular dermal matrix (ADM) with one of the investigators' two surgeons, Dr. Steven Davison or Dr. Ximena Pinell, are eligible to be enrolled. Patients' breasts will be randomized to receive either AlloDerm or DermACELL so that each patient had AlloDerm placed in one breast and DermACELL placed in the other on the day of surgery. Then, the following data for each breast will be recorded: time until drain removal, total drain output, time until first expander fill, and occurrences of infection and seroma.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients over the age of 18
  • May be undergoing either therapeutic or prophylactic mastectomy
  • Must be undergoing bilateral mastectomy and breast reconstruction with tissue expanders

Exclusion criteria

  • Patients who wish to avoid the use of ADM in their reconstruction
  • History of radiation of the breast
  • Unilateral mastectomies
  • Direct to implant breast reconstruction (not utilizing a tissue expander)

Treatment and study plan

AlloDerm

Other

Enrolled patients will have one of their breasts reconstructed with AlloDerm at the time of their breast reconstruction surgery.

DermACELL

Other

Enrolled patients will have one of their breasts reconstructed with DermACELL at the time of their breast reconstruction surgery.

Primary outcomes

  1. Drain time

    Time frame: Up to 90 days

    Number of days between surgical placement of drains and time until drains are removed.

  2. Drain output

    Time frame: Up to 90 days

    Total amount of fluid collected by the drains until their removal (measured in cc).

  3. Incidence of Seroma

    Time frame: Up to 90 days

    Each patient will be evaluated for incidence of seroma in either breast at postoperative visits.

  4. Incidence of Infection

    Time frame: Up to 90 days

    Each patient will be evaluated for incidence of infection in either breast at postoperative visits.

Secondary outcomes

  1. Incidence of Skin necrosis

    Time frame: Up to 90 days

    Each patient will be evaluated for skin necrosis of either breast at postoperative visits.

  2. Incidence of Hematoma

    Time frame: Up to 90 days

    Each patient will be evaluated for incidence of hematoma in either breast at postoperative visits.

  3. Incidence of Device Explantation

    Time frame: Up to 90 days

    If patients require device explantation in one breast due to complications (e.g. infection).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2021
Registry last updated
Aug 4, 2022

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.