Immediate Postmastectomy Breast Reconstruction
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy|
- Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix [ Time Frame: At the time of expander/implant exchange (Stage II), ] [ Designated as safety issue: No ]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 %.
- Severity of Local Inflammation at and Around the Surgical Site [ Time Frame: Postoperative Day 7, 14, 21, 30 days ] [ Designated as safety issue: Yes ]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).
Biospecimen Retention: Samples Without DNA
|Study Start Date:||October 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Device: LTM - a porcine-based surgical mesh
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|United States, District of Columbia|
|Washington, District of Columbia, United States|
|United States, Illinois|
|Chicago, Illinois, United States|
|United States, New York|
|Great Neck, New York, United States|
|United States, Pennsylvania|
|Willow Grove, Pennsylvania, United States|
|United States, Virginia|
|McLean, Virginia, United States|
|Study Director:||Michael Franz, MD||LifeCell|