Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12
Objective Evaluation of Collagen Deposition in AlloMaxTM Acellular Dermal Matrix in Breast Reconstruction Version 8-15-12
1 other identifier
observational
60
1 country
1
Brief Summary
The purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction. The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast capsule at the 3-4 month time point.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2012
CompletedFirst Posted
Study publicly available on registry
September 5, 2012
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJanuary 9, 2015
January 1, 2015
4.8 years
August 31, 2012
January 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Hydroxyproline Concentration
Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule.
3-4 months
Neoangiogenesis
Measure new blood vessels in AlloMaxTM and adjacent capsule
3-4 months
Collagen I and III
Measure collagen I and III in AlloMaxTM and adjacent capsule
3-4 months
Study Arms (3)
<40 years
subjects aged less than 40 years
40-60 years
subjects aged 40-60years
> 60 years
subjects aged greater than 60 years
Eligibility Criteria
Patients (18 - 70 yrs) scheduled for immediate two stage breast reconstruction with AlloMaxTM are potential subjects for this study
You may qualify if:
- Adult patients (18 - 70 yrs) who require reconstructive breast surgery with AlloMaxTM implants and agree to participate will be included in this study.
You may not qualify if:
- Patients who do not agree to be included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nevada School of Medicine
Las Vegas, Nevada, 89102-2227, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kayvan Taghipour-Khiabani, M.D.
University of Nevada School of Medicine
- STUDY CHAIR
William A Zamboni, M.D.
University of Nevada School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Tenured Associate Professor, Head of Hand and Microsurgery
Study Record Dates
First Submitted
August 31, 2012
First Posted
September 5, 2012
Study Start
February 1, 2014
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
January 9, 2015
Record last verified: 2015-01