Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12

• Conditions: Breast Cancer

• Registration Number: NCT01679223
• Lead Sponsor: University of Nevada, Las Vegas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-08-31
• Study First Posted: 2012-09-05
• Study Start: 2014-02
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-08
• Last Update Posted: 2015-01-09
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Nevada School of Medicine; 🇺🇸 Las Vegas, Nevada, United States