Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12

January 8, 2015 updated by: Kayvan Taghipour-Khiabani, M.D., University of Nevada, Las Vegas

Objective Evaluation of Collagen Deposition in AlloMaxTM Acellular Dermal Matrix in Breast Reconstruction Version 8-15-12

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89102-2227
        • Recruiting
        • University of Nevada School of Medicine
        • Contact:
        • Principal Investigator:
          • Kayvan Taghipour-Khiabani, M.D.
        • Sub-Investigator:
          • William A Zamboni, M.D.
        • Sub-Investigator:
          • Richard C Baynosa, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
<40 years
subjects aged less than 40 years
40-60 years
subjects aged 40-60years
> 60 years
subjects aged greater than 60 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hydroxyproline Concentration
Time Frame: 3-4 months
Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule.
3-4 months
Neoangiogenesis
Time Frame: 3-4 months
Measure new blood vessels in AlloMaxTM and adjacent capsule
3-4 months
Collagen I and III
Time Frame: 3-4 months
Measure collagen I and III in AlloMaxTM and adjacent capsule
3-4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

August 31, 2012

First Submitted That Met QC Criteria

August 31, 2012

First Posted (Estimate)

September 5, 2012

Study Record Updates

Last Update Posted (Estimate)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 8, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 081512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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