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Tissue Matrix
AlloDerm for Acellular Dermal Matrix
N/A
Waitlist Available
Led By Steven P Davison, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights
Study Summary
This study is evaluating whether a type of tissue expander may be better than another type of tissue expander for breast reconstruction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Drain output
Drain time
Incidence of Infection
+1 moreSecondary outcome measures
Incidence of Device Explantation
Incidence of Hematoma
Incidence of Skin necrosis
Trial Design
2Treatment groups
Active Control
Group I: AlloDermActive Control1 Intervention
AlloDerm will be surgically implanted into each participant (either in their left or right breast) at the time of their breast reconstruction surgery. AlloDERM will be placed in the breast opposite to the breast in which DermACELL is placed, so that the patient has AlloDERM in the right breast and DermACELL in the left breast, or vice versa.
Group II: DermACELLActive Control1 Intervention
DermACELL will be surgically implanted into each participant (either in their left or right breast) at the time of their breast reconstruction surgery. DermACELL will be placed in the breast opposite to the breast in which AlloDERM is placed, so that the patient has AlloDERM in the right breast and DermACELL in the left breast, or vice versa.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,256 Previous Clinical Trials
14,820,021 Total Patients Enrolled
Steven P Davison, MDPrincipal InvestigatorSibley Memorial Hospital
Frequently Asked Questions
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