Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction
NCT ID: NCT02263261
Last Updated: 2018-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-03-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Flex HD Pliable Perforated HADM
Single Arm
Flex HD Pliable Perforated HADM
Human Acellular Dermal Matrix
Interventions
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Flex HD Pliable Perforated HADM
Human Acellular Dermal Matrix
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Musculoskeletal Transplant Foundation
OTHER
Responsible Party
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Locations
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Liu Plastic surgery
Mountain View, California, United States
Liu Plastic Surgery
San Jose, California, United States
Countries
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Other Identifiers
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MTF 13-03
Identifier Type: -
Identifier Source: org_study_id
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