Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction



Status:Completed
Conditions:Breast Cancer, Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery, Oncology
Healthy:No
Age Range:18 - Any
Updated:9/22/2018
Start Date:March 2015
End Date:November 2016

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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

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

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.

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.
We found this trial at
2
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San Jose, California 95124
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San Jose, CA
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Mountain View, California 94040
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Mountain View, CA
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