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OpenTrials
Completed

NCT Number: NCT02263261

Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

Use of a HADM and implant in post-mastectomy breast reconstruction.

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Key information

Conditions

Mastectomy Breast Reconstruction

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Liu Plastic surgery, Mountain View, California, United States

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About this study

This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled to undergo a single or two-stage, tissue-assisted, implant breast reconstruction
  • Mastectomy may be unilateral or bilateral, prophylactic or therapeutic
  • Skin incision may be skin sparing, or nipple-areolar sparing
  • Have signed written, informed consent
  • Be at least 18 years of age

Exclusion criteria

  • Patients undergoing autologous breast reconstruction
  • Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)
  • Patients undergoing reconstruction after previously failed attempts at reconstruction
  • Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)
  • There will be no exclusions based on race or ethnicity
  • BMI > 40
  • Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.

Treatment and study plan

Flex HD Pliable Perforated HADM

Other

Human Acellular Dermal Matrix

Primary outcomes

  1. Types and incidence of complications

    Time frame: 6 months post reconstruction

    Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure

Secondary outcomes

  1. Aesthetic Outcomes

    Time frame: 6 months post reconstruction

    Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise

  2. Patient-Reported Outcomes

    Time frame: 6 months post reconstruction

    Use of the Breast Q survey instrument

Sponsors and collaborators

Lead sponsor

Musculoskeletal Transplant Foundation

Other

Registry information

Official study title

Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2014
Registry last updated
Sep 20, 2018

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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