Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

Study Overview
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Brief Summary
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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
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nothing to add

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: LTM - a porcine-based surgical mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: LTM - a porcine-based surgical mesh|Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast reconstruction