Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Nevada, Las Vegas
Sponsor:
Information provided by (Responsible Party):
Kayvan Taghipour-Khiabani, M.D., University of Nevada, Las Vegas
ClinicalTrials.gov Identifier:
NCT01679223
First received: August 31, 2012
Last updated: May 1, 2014
Last verified: May 2014
  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:


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 2014
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (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
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 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 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, Las Vegas
ClinicalTrials.gov Identifier: NCT01679223     History of Changes
Other Study ID Numbers: 081512
Study First Received: August 31, 2012
Last Updated: May 1, 2014
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 October 19, 2014