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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2018-09-01
2021-05-01
Brief Summary
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Prior to surgery, the registered subject will be randomized to receive the D-ADM without the basement membrane or the comparator, FlexHD Pliable. The surgeon and the patient will be blinded to the product group. The patient will receive the ADM at the time of placement of the tissue expander. After a period of tissue expansion, the patient will have the expander-implant exchange. During this surgery, there will be 3 punch biopsies taken in 3 different locations: native breast tissue, center of the ADM, and the border of the ADM and subject's breast tissue. These specimens will be analyzed to estimate differences in immunologic and inflammatory response for each ADM product.
The patient will follow up with the surgeon at 1-3 weeks, 3 months, 6 months, 9 months, and 12 months post implant exchange. At these visits, the surgeon will assess for any adverse events and this information will be collected for research purposes. The patient will be asked to complete the reconstruction module of the Breast-Q at the baseline visit and 6 and 12 months to assess quality of life and patient satisfaction.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dermacell ADM without basement membrane
Dermacell ADM without a basement membrane
Dermacell ADM without basement membrane
Patient will be implanted with Dermacell ADM.
FlexHD
FDA-approved FlexHD Pliable
FlexHD
Patient will be implanted with FlexHD.
Interventions
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Dermacell ADM without basement membrane
Patient will be implanted with Dermacell ADM.
FlexHD
Patient will be implanted with FlexHD.
Eligibility Criteria
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Inclusion Criteria
* Candidate for and decide to undergo implant-based reconstruction
* Willing and able to provided written informed consent and comply with the study protocol.
Exclusion Criteria
* Women planning to undergo adjuvant chemotherapy.
* Women who have had prior breast cancer treated with breast conservation therapy requiring radiation for the same breast being treated will be excluded.
* Known sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin.
* Women who have the presence of any condition that in the opinion of the investigator places the participant at undue risk or potentially jepordizes the quality of data to be generated.
18 Years
75 Years
FEMALE
No
Sponsors
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LifeNet Health
INDUSTRY
University of Virginia
OTHER
Responsible Party
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Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20295
Identifier Type: -
Identifier Source: org_study_id
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