Immediate Postmastectomy Breast Reconstruction - Full Text View

Sponsored by:	LifeCell
Information provided by:	LifeCell
ClinicalTrials.gov Identifier:	NCT00619762

Purpose

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.

Condition	Intervention
Mastectomy	Device: LTM - a porcine-based surgical mesh

MedlinePlus related topics: Breast Reconstruction Mastectomy

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy

Further study details as provided by LifeCell:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Tissue sample

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

women undergoing two-stage immediate breast reconstruction following a skin sparing mastectomy will be recruited from up to ten (10) participating centers

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619762

Locations

United States, District of Columbia

Washington, District of Columbia, United States
United States, Illinois

Chicago, Illinois, United States
United States, New York

Great Neck, New York, United States
United States, Pennsylvania

Willow Grove, Pennsylvania, United States
United States, Virginia

McLean, Virginia, United States

Sponsors and Collaborators

LifeCell

More Information

Responsible Party:	LifeCell Corporation ( Janice M. Smiell, MD )
Study ID Numbers:	LFC2007.01.01
Study First Received:	January 11, 2008
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00619762
Health Authority:	United States: Institutional Review Board

Keywords provided by LifeCell:

Breast reconstruction

ClinicalTrials.gov processed this record on January 16, 2009