NL-OMON48115已完成不适用
An Observational, Prospective Multicentre Clinical Study to assess the safety and clinical performance of a New Single-use Negative Pressure Wound Therapy System (PICO 7Y) for the Simultaneous Management of Bilateral Closed Incisions in Oncoplastic Breast Surgery Patients - PICO7Y
Smith&Nephew, Inc0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. The subject must have understood and provided written informed consent
- •2. Female subjects who must be at least eighteen (18) years of age.
- •3. Willing and able to make all required study visits.
- •4. Able to follow instructions.
- •5. Subjects must be undergoing, at the same time, both an oncoplastic breast
- •surgery and a symmetrising breast reduction on the contralateral breast and
- •have closed incisions that would benefit from NPWT.
- •6. Subjects whose incisions will fit comfortably within the area of the pad of
- •the dressing sizes provided.
排除标准
- •1. Contraindications (per the PICO 7Y IFU) or hypersensitivity to the use of
- •the investigational product or their components (i.e., silicone adhesives and
- •polyurethane films [direct contact with wound], acrylic adhesives [direct
- •contact with skin], polyethylene fabrics and super-absorbent powders
- •[polyacrylates]) within the dressing.
- •2. Subjects with skin features (e.g. tattoos, skin colour, pre-existing
- •scarring) which in the opinion of the Investigator, will interfere with the
- •study assessments.
- •3. Suspected or confirmed allergy to any of the components of the ancillary
- •products should they be deemed required, e.g. in the case of SECURA No-sting
- •barrier skin wipes for patients with fragile skin.
- •4. Subjects with a local infection, close or at the site of the incision, at
- •the time of surgery
- •5. Subjects with incisions that are actively bleeding unless haemostasis has
- •been achieved.
- •6. Subjects with a genetic or acquired disease capable of negatively impact the
- •closed incision healing.
- •7. Subjects with a history of poor compliance with medical treatment.
- •8. Subjects who have participated previously in this clinical trial.
- •9. Subjects with a medical or physical condition that, in the opinion of
- •the Investigator, would preclude safe subject participation in the study.
- •10. Individuals from vulnerable populations including pregnant women and adult
- •females over 75 years.
- •11. Subjects who have received neo adjuvant chemotherapy within the last 30
- •days prior to surgery.
- •12. Patients who at the end of the surgery have only one breast operated.
研究者
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