Porcine Acellular Dermal Matrix (PADM)-Assisted Implant-based Breast Reconstruction: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 10
- 主要终点
- Rate of adverse events. Main complications of interest: infection, cellulitis, seroma, hematoma, skin flap-nipple necrosis, delayed wound healing, wound dehiscence, red breast syndrome, capsular contracture, implant related
研究概览
简要总结
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Breast membranes used in breast reconstruction and to identify emerging risks in comparison to clinical data related to other treatment modalities.
The present study will be a prospective, multicentric, non-randomized and non-controlled trial involving 112 patients followed for 24 months. The study will be conducted in France in 7 investigational centres.
详细描述
The study will be prospective, multicentric, single-arm observational (non-interventional) to evaluate the safety and performance of the CELLIS Breast membranes used in breast reconstruction following mastectomy.
All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.
The study will be conducted in France in 7 investigational centres including 112 patients scheduled for a breast reconstruction following mastectomy.
Each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period.
Patients will return for ambulatory visits on day 10 (+/- 5 days) and/or on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient aged ≥18 years,
- •Patient with an indication of breast reconstruction after mastectomy (therapeutic or prophylactic),
- •Patient being informed of her participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
- •Patient being informed of the porcine origin of the device in advance of the procedure.
排除标准
- •Patient with known hypersensitivity to porcine materials,
- •Patient with an existing infection at the site of implantation,
- •Patient having refused to participate to the study,
- •Patient refusing to return for the follow-up visits,
- •Patient who is pregnant.
结局指标
主要结局
Rate of adverse events. Main complications of interest: infection, cellulitis, seroma, hematoma, skin flap-nipple necrosis, delayed wound healing, wound dehiscence, red breast syndrome, capsular contracture, implant related
时间窗: From the surgical procedure throughout the entire 24-month follow-up period
Percentage
次要结局
- Surgeon aesthetic evaluation: satisfaction related to the quality of the reconstruction (very good, good, fair, bad), suppleness (Visual Analog Scale score from 1 to 10 with 10=excellent suppleness) and symmetry (very good, good, fair, bad).(At the 3, 12 and 24-month follow-up visits)
- Patient-reported pain using a visual analogue scale (VAS) scored from 0 to 10 (0=no pain; 10=worse pain).(At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits)
- Quality of life (QoL) by the use of the SF-36 questionnaire.(At baseline and at 24 month)
- Patient aesthetic evaluation evaluated by Visual Analog Scale (VAS). The suppleness of the reconstruction will be evaluated (natural-hard): VAS score from 1 to 10 (1=very bad suppleness, breast hard; 10=excellent suppleness-natural breast).(At the 3, 12 and 24-month follow-up visits)
- Patient analgesics consumption(At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits)
- Description of device deficiency: inadequacy of a medical device with respects to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.(During the surgical procedure)