Breast Cancer Clinical Trial

Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

Summary

This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with the use of LTM in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.

View Full Description

Full Description

nothing to add

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

A candidate for immediate, two-stage breast reconstruction using LTM following a skin sparing mastectomy
An ASA Physical Status Classification5 of 1 or 2 (see App I)
Estimated life expectancy > 1 year

Exclusion Criteria:

Clinically significant systemic disease
Received inductive chemo-therapy within 2 months prior to mastectomy or radiation therapy to the region at any time
Predicted excised breast mass of >750 gms
Co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, smoking, chronic steroid use, malnourishment, or co-existent infection
Need for tissue flap in addition to expander
History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
Enrollment or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial
Any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate

Study is for people with:

Breast Cancer

Estimated Enrollment:

17

Study ID:

NCT00619762

Recruitment Status:

Completed

Sponsor:

LifeCell

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You


Washington District of Columbia, , United States

Chicago Illinois, , United States

Great Neck New York, , United States

Willow Grove Pennsylvania, , United States

McLean Virginia, , United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

17

Study ID:

NCT00619762

Recruitment Status:

Completed

Sponsor:


LifeCell

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider