NPWT Pre-registration Study: A Prospective, Multicentre Trial to Assess Performance, Safety and Efficacy of a Single-use NPWT Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 8
- 主要终点
- Negative Pressure Maintenance at Nominal 80 mmHg
研究概览
简要总结
Smith & Nephew are assessing a new investigational single use NPWT system.
详细描述
Smith & Nephew are assessing a new investigational single use NPWT system. There is a significant amount of clinical evidence to show that NPWT may reduce oedema, increase healing and reduce chance of infection, through maintenance of pressure therapy, in closed incisions. Subjects with abdominal incisions and knee incisions following knee surgery will be recruited to the study and receive NPWT for 7 days. The performance of the system will be logged by the device and acceptability of the device will be assessed by patient and clinician. Safety will be assessed with a 30 day follow up to assess complications and device related events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must provide written informed consent.
- •Subjects eighteen (18) years of age or older.
- •Willing and able to make all required study visits.
- •Able to follow instructions.
- •Subject is suitable to participate in the study in the opinion of the Investigator
- •In Orthopaedic surgery: subject is scheduled for an elective primary knee replacement arthroplasty and American Society of Anesthesiologists (ASA) score of 2-3 (Phase 1 only)
- •In Abdominal surgery: subject is scheduled for an elective open or laparoscopic gastrointestinal and/or gynaecological surgery with incision ≥5 cm and has an ASA score of 2-
- •Immediately after the surgery, subject will have one suitable closed abdominal or knee surgery incision (if there is more than one incision, then the clinician should choose the one which, in their opinion, is most suited for Negative Pressure Wound Therapy) that fits under the absorbent dressing area of the appropriate Negative Pressure dressing sizes .
排除标准
- •Contraindications (per the Investigator Brochure) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives [direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the dressing).
- •Subjects with extremely fragile skin who require the use of SECURA™ non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes
- •Participation in the treatment period of another similar clinical trial (wound care related) within thirty (30) days of operative visit or during the study.
- •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.
- •Subjects attending for an operation at the same surgery site (anatomical location) within the last 3 months
- •Subjects undergoing a procedure as part of palliative care (to be confirmed during surgery).
- •Subjects where the area of the device would be placed on a load-bearing anatomical location (i.e. areas vulnerable to pressure damage).
- •Subjects with incisions that are actively bleeding unless haemostasis has been achieved (to be confirmed during surgery).
- •Subjects with infected skin lesions or incisions at the time of surgery (any area of the body).
- •Subjects who have participated previously in this clinical trial
- •Subjects with a history of poor compliance with medical treatment.
- •Subjects with a BMI ≥
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
研究组 & 干预措施
Abdominal
Abdominal surgery type with investigational single use NPWT dressing
干预措施: Negative-Pressure Wound Therapy (NPWT) (Device)
Knee
Knee surgery type with investigational single use NPWT dressing
干预措施: Negative-Pressure Wound Therapy (NPWT) (Device)
结局指标
主要结局
Negative Pressure Maintenance at Nominal 80 mmHg
时间窗: 30 days post-op
Negative pressure maintenance at nominal 80 mmHg assessed as the average of the negative pressure values recorded by the device for Abdominal and Knee surgery types. This data was summarized to show an average negative pressure provided over the treatment duration.
Dressing Wear Time
时间窗: 7 days
Dressing wear time in days as assessed of any unplanned dressing change by Abdominal and Knee surgery type.
Exudate Management (Occurrence of Exudate Leaks)
时间窗: 7 days
Number of participants with occurrence of exudate leaks. Leakage classified as 'Any Leak' (Yes/No) by Abdominal and Knee surgery type.
次要结局
- Incidence of Surgical Site Infection (SSI)(30 days)
- Incidence of Surgical Site Complications (SSC)(30 days)
- Condition of Peri-Wound Skin Assessed Through Visual Inspection(Baseline, 7 days, 14 days, and 30 days)
- Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection(Baseline, 7 days, 14 days, and 30 days)
- Wound and Skin Visual Analog Scale (VAS) Score Assessment(7 days, 14 days, and 30 days)
- Range of Motion Assessment (ROM) for the Knee(30 days)
- Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score(4 days and 7 days)
- Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score(7 days)