MedDataX Logo

Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

NCT ID: NCT00619762

Last Updated: 2016-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

nothing to add

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Breast reconstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LTM - a porcine-based surgical mesh

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

LifeCell

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Franz, MD

Role: STUDY_DIRECTOR

LifeCell

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington D.C., District of Columbia, United States

Site Status

Chicago, Illinois, United States

Site Status

Great Neck, New York, United States

Site Status

Willow Grove, Pennsylvania, United States

Site Status

McLean, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LFC2007.01.01

Identifier Type: -

Identifier Source: org_study_id