Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12

Nevada System of Higher Education (NSHE)

Status: Unknown

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01679223

081512

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

60 participants in 3 patient groups

<40 years

Description:

subjects aged less than 40 years

40-60 years

Description:

subjects aged 40-60years

> 60 years

Description:

subjects aged greater than 60 years