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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Human Acellular Dermal Matrix
Liu Plastic surgery
Mountain View, California, United States
Liu Plastic Surgery
San Jose, California, United States
Types and incidence of complications
Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure
Time frame: 6 months post reconstruction
Aesthetic Outcomes
Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise
Time frame: 6 months post reconstruction
Patient-Reported Outcomes
Use of the Breast Q survey instrument
Time frame: 6 months post reconstruction
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