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Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by University of Nevada, Las Vegas
Information provided by (Responsible Party):
Kayvan Taghipour-Khiabani, M.D., University of Nevada, Las Vegas Identifier:
First received: August 31, 2012
Last updated: January 8, 2015
Last verified: January 2015
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.

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:

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

Primary Outcome Measures:
  • Hydroxyproline Concentration [ Time Frame: 3-4 months ]
    Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule.

  • Neoangiogenesis [ Time Frame: 3-4 months ]
    Measure new blood vessels in AlloMaxTM and adjacent capsule

  • Collagen I and III [ Time Frame: 3-4 months ]
    Measure collagen I and III in AlloMaxTM and adjacent capsule

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
<40 years
subjects aged less than 40 years
40-60 years
subjects aged 40-60years
> 60 years
subjects aged greater than 60 years


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01679223

Contact: Kayvan Taghipour-Khiabani, M.D. 702-671-2267
Contact: Shelley J Williams, M.S. 702-895-1445

United States, Nevada
University of Nevada School of Medicine Recruiting
Las Vegas, Nevada, United States, 89102-2227
Contact: Sherree Mounts, LPN    702-671-5117   
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
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

Responsible Party: Kayvan Taghipour-Khiabani, M.D., Tenured Associate Professor, Head of Hand and Microsurgery, University of Nevada, Las Vegas Identifier: NCT01679223     History of Changes
Other Study ID Numbers: 081512
Study First Received: August 31, 2012
Last Updated: January 8, 2015

Keywords provided by University of Nevada, Las Vegas:
Breast reconstruction
Hydroxyproline concentration
collagen deposition processed this record on May 25, 2017