A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LifeCell
- 入组人数
- 17
- 主要终点
- Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix
研究概览
简要总结
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.
详细描述
nothing to add
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix
时间窗: At the time of expander/implant exchange (Stage II),
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 %.
次要结局
- Severity of Local Inflammation at and Around the Surgical Site(Postoperative Day 7, 14, 21, 30 days)