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Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12

This study is not yet open for participant recruitment.
Verified September 2012 by University of Nevada, Las Vegas
Sponsor:
Information provided by (Responsible Party):
Kayvan Taghipour-Khiabani, M.D., University of Nevada
ClinicalTrials.gov Identifier:
NCT01679223
First received: August 31, 2012
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Objective Evaluation of Collagen Deposition in AlloMaxTM Acellular Dermal Matrix in Breast Reconstruction Version 8-15-12

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nevada, Las Vegas:

Primary Outcome Measures:
  • Hydroxyproline Concentration [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
    Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule.

  • Neoangiogenesis [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
    Measure new blood vessels in AlloMaxTM and adjacent capsule

  • Collagen I and III [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
    Measure collagen I and III in AlloMaxTM and adjacent capsule


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
<40 years
subjects aged less than 40 years
40-60 years
subjects aged 40-60years
> 60 years
subjects aged greater than 60 years

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients (18 - 70 yrs) scheduled for immediate two stage breast reconstruction with AlloMaxTM are potential subjects for this study

Criteria

Inclusion Criteria:

  • Adult patients (18 - 70 yrs) who require reconstructive breast surgery with AlloMaxTM implants and agree to participate will be included in this study.

Exclusion Criteria:

  • Patients who do not agree to be included in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679223

Contacts
Contact: Kayvan Taghipour-Khiabani, M.D. 702-671-2267 kkhiabani@medicine.nevada.edu
Contact: Linda L Stephenson, BS MT(ASCP) 702-895-3315 lstephenson@medicine.nevada.edu

Locations
United States, Nevada
University of Nevada School of Medicine Not yet recruiting
Las Vegas, Nevada, United States, 89102-2227
Contact: Sherree Mounts, LPN     702-671-5117     smounts@medicine.nevada.edu    
Principal Investigator: Kayvan Taghipour-Khiabani, M.D.            
Sub-Investigator: William A Zamboni, M.D.            
Sub-Investigator: Richard C Baynosa, M.D.            
Sponsors and Collaborators
University of Nevada, Las Vegas
Investigators
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
  More Information

No publications provided

Responsible Party: Kayvan Taghipour-Khiabani, M.D., Tenured Associate Professor, Head of Hand and Microsurgery, University of Nevada
ClinicalTrials.gov Identifier: NCT01679223     History of Changes
Other Study ID Numbers: 081512
Study First Received: August 31, 2012
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nevada, Las Vegas:
Breast reconstruction
Hydroxyproline concentration
neoangiogenesis
collagen deposition

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013