Status:
COMPLETED
Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction
Lead Sponsor:
Musculoskeletal Transplant Foundation
Conditions:
Mastectomy
Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Use of a HADM and implant in post-mastectomy breast reconstruction.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02263261
Start Date
March 1 2015
End Date
November 1 2016
Last Update
September 20 2018
Active Locations (2)
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1
Liu Plastic surgery
Mountain View, California, United States, 94040
2
Liu Plastic Surgery
San Jose, California, United States, 95124