A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy
18 Years
N/A
Female
Breast Cancer
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
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
Type of Study:
Observational
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:
No
Principal Investigator
Michael Franz, MD
Investigator Role:
Study Director
Investigator Affiliation:
LifeCell
Authority:
United States: Institutional Review Board
Study ID:
LFC2007.01.01
NCT ID:
NCT00619762
Start Date:
October 2007
Completion Date:
December 2009
Related Keywords:
- Breast Cancer
- Breast reconstruction
- Breast Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Albany, New York 12208 | |
| Philadelphia, Pennsylvania 19104 | |
| McLean, Virginia 22101 | |
| Washington, District of Columbia |
