Randomized and Blinded Clinical Evaluation of Dermacell Without Basement Membrane in Breast Reconstruction.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Seroma Formation
研究概览
简要总结
DermACELL acellular dermal matrix (D-ADM) is the trade name of LifeNet Health's acellular dermal matrix (ADM). LifeNet Health will remove the basement membrane from the D-ADM and this product will be compared to FlexHD® Pliable, which does not include a basement membrane in order to demonstrate that D-ADM without a basement membrane is not inferior to FlexHD in the frequency of significant side effects that result from breast implants. This is a post market trial that is comparing two ADM products with a known safety profile. The D-ADM without a basement membrane is being prepared specifically for this UVA evaluation. Removal of the basement membrane by the manufacturer is considered minimal manipulation. D-ADM without a basement membrane will be considered a human cell, tissue, and cellular and tissue-based product (HCT/P) and is eligible for marketing immediately within the US, if desired by LifeNet Health (LNH). Additionally, the applications of the products are indicated. Therefore, the trial is not in support of an Investigational Device Exemption (IDE).
Prior to surgery, the registered subject will be randomized to receive the D-ADM without the basement membrane or the comparator, FlexHD Pliable. The surgeon and the patient will be blinded to the product group. The patient will receive the ADM at the time of placement of the tissue expander. After a period of tissue expansion, the patient will have the expander-implant exchange. During this surgery, there will be 3 punch biopsies taken in 3 different locations: native breast tissue, center of the ADM, and the border of the ADM and subject's breast tissue. These specimens will be analyzed to estimate differences in immunologic and inflammatory response for each ADM product.
The patient will follow up with the surgeon at 1-3 weeks, 3 months, 6 months, 9 months, and 12 months post implant exchange. At these visits, the surgeon will assess for any adverse events and this information will be collected for research purposes. The patient will be asked to complete the reconstruction module of the Breast-Q at the baseline visit and 6 and 12 months to assess quality of life and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of breast cancer
- •Candidate for and decide to undergo implant-based reconstruction
- •Willing and able to provided written informed consent and comply with the study protocol.
排除标准
- •Women planning to undergo radiation treatment or whose tumor characteristics of the mastectomy specimen dictate that post-op radiation will be required.
- •Women planning to undergo adjuvant chemotherapy.
- •Women who have had prior breast cancer treated with breast conservation therapy requiring radiation for the same breast being treated will be excluded.
- •Known sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin.
- •Women who have the presence of any condition that in the opinion of the investigator places the participant at undue risk or potentially jepordizes the quality of data to be generated.
研究组 & 干预措施
Dermacell ADM without basement membrane
Dermacell ADM without a basement membrane
干预措施: Dermacell ADM without basement membrane (Procedure)
FlexHD
FDA-approved FlexHD Pliable
干预措施: FlexHD (Procedure)
结局指标
主要结局
Seroma Formation
时间窗: 12 months
Determine severity of seroma formation with each arm by observing drainage output and if seroma requires significant surgical intervention.
次要结局
- Red breast syndrome(12 months)
- Infection(12 months)
- Capsular Contracture(12 months)
- QOL(12 months)
- Histological Assessment(Day 1)