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

18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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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

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix

Outcome Description:

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 %.

Outcome Time Frame:

At the time of expander/implant exchange (Stage II),

Safety Issue:


Principal Investigator

Michael Franz, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • Breast reconstruction
  • Breast Neoplasms



Hinsdale, Illinois  60521
Albany, New York  12208
Philadelphia, Pennsylvania  19104
McLean, Virginia  22101
Washington, District of Columbia