Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01679223

Enrollment

Registered

2012-09-05

Start date

2014-02-28

Completion date

2018-11-30

Last updated

2015-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast reconstruction, Hydroxyproline concentration, neoangiogenesis, collagen deposition

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactKayvan Taghipour-Khiabani, M.D.

kkhiabani@medicine.nevada.edu702-671-2267

Backup ContactShelley J Williams, M.S.

sjwilliams@medicine.nevada.edu702-895-1445

Outcome results