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Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy

NCT00619762•LifeCell

View on ClinicalTrials.gov

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.

Detailed Description

nothing to add

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (5)

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

Chicago, Illinois, United States

Great Neck, New York, United States

Willow Grove, Pennsylvania, United States

McLean, Virginia, United States

Key Dates

Start Date

October 1, 2007

Primary Completion Date

October 1, 2009

Completion Date

December 1, 2009

Last Updated

November 8, 2016

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

LTM - a porcine-based surgical mesh

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer