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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: LTM - a porcine-based surgical mesh

Detailed Description

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• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Illinois
    • Chicago, Illinois, United States
  • New York
    • Great Neck, New York, United States
  • Pennsylvania
    • Willow Grove, Pennsylvania, United States
  • Virginia
    • McLean, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix	Evaluation of 3 histology parameters, fibroblast infiltration, immune cell response & revascularization, expressed as frequency distributions. Samples evaluated for presence of fibroblasts (cellularity), neovascularization & immune cell response using 4 pt scale. Fibroblast Infiltration: 1=None,2=Few,sparse,3=Moderate,4=Dense. Revascularization:1=None,2=Few randomly dispersed capillaries,3=Moderate; mostly homogenous distribution of new vessels,4=Significant,uniformly distributed vessels; both capillaries and arterioles. Immune Cell response: 1= None,2=Few,normal healing response,3=Moderate,4=Significant;above expected presence for healing. 4 high power(HP)fields reviewed & if uniform in appearance/cellular distribution, 4 considered representative of sample as a whole. If non-uniform distribution observed, 3 HP fields of "sparse or light" distribution & 3 HP fields of dense distribution counted & results averaged. Tissue sample then assessed for overall acellularity & expressed as %.	At the time of expander/implant exchange (Stage II),

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Local Inflammation at and Around the Surgical Site	The Inflammatory response was evaluated by each of the four cardinal signs: erythema, edema, pain and heat, using standard scales for the evaluation of each sign and inflammation as a whole was assessed using a model (AIR Score) which took into account the scores assigned to each of the four signs. A mean score is provided at each timepoint.The minimum total possible score is 4 (less inflamation) and the maximum total possible score is 8 (more inflammation).	Postoperative Day 7, 14, 21, 30 days

Collaborators and Investigators

• Sponsor: LifeCell
• Investigators: Study Director: Michael Franz, MD, LifeCell

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: January 11, 2008
• First Submitted That Met QC Criteria: February 11, 2008
• First Posted (Estimate): February 21, 2008

Study Record Updates

• Last Update Posted (Estimate): November 8, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Breast reconstruction
• Other Study ID Numbers: LFC2007.01.01