A Clinical Evaluation of a Novel, Single-Use, Negative Pressure Wound Therapy (NPWT) System for the Management of Closed Surgical Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Mean (median) number of days of negative pressure delivered to the incision up to day 7
研究概览
简要总结
A study of the first clinical use in humans of a novel NPWT system (npSIMS) to assess the suitability, safety and efficacy of the system for the management of closed surgical wounds
详细描述
The purpose of this investigation is to test the functionality of a novel, non-electric NPWT device: npSIMS (negative pressure Surgical Incision Management System) from Aatru Medical LLC (Ohio, USA) which uses an exothermic chemical process to extract the oxygen from the air contained within the dressing (air contains 21% O2) and hence bring and maintain the system to between -160 and -80 mmHg below atmospheric pressure (760 mmHg). The dressing and the chemical reaction pump module can be manufactured for significantly less than the cost of electromechanical NPWT systems and can be profitably marketed at a discount to the cost of existing commercial devices. The Aatru Medical NPWT system could transform the economics and increase the availability of this therapy across the world.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Participant is male or female ≥ 18 years of age
- •Participant will undergo an elective sternotomy, thoracotomy, caesarean section (C-section) or skin surgery incision with closure by sutures or staples
- •Participant will undergo a surgical procedure resulting in a closed approximately linear incision between 5 cm and 13 cm in length inclusive so that the npSIMS dressing covers the wound with a minimum of 1 cm overlap at each end
- •Participant is willing and able to take part in the study and provide written informed consent.
排除标准
- •Participants will undergo post-surgical radiotherapy or chemotherapy
- •Participants who, in the opinion of the Investigator, have an existing health condition that would compromise their participation and follow-up in this study
- •Participant will undergo emergency surgery
- •Participant is sensitive to or known to have allergies to silicone/acrylic adhesives
- •Participant has malignancy in the wound bed or margins of the wound
- •Participant has wound with confirmed and untreated osteomyelitis
- •Participant has wound with non-enteric and unexplored fistulas
- •Participant has wound with necrotic tissue with eschar present
- •Participant has exposed arteries, veins, nerves or organs
- •Participant has exposed anastomotic sites
结局指标
主要结局
Mean (median) number of days of negative pressure delivered to the incision up to day 7
时间窗: 7 days
To assess the maintenance and reliability with which negative pressure is delivered for the 7-day NPWT period.
次要结局
- Mean (median) overall observer and participant scores in the POSAS - Patient Observer Scar Assessment Scale on day 14 ±2 clinic follow up.(14 days)
- Mean (median) days wear time of the adhesive dressing up to day 7(7 days)
- Frequency of surgical wound complications according to the ASEPSIS wound score at day 14 ±2 clinic and day 30±2 remote follow up.(30 Days)
- Mean (median) ease of use score from patients on 5-point NRS (numerical rating score) assessed at day 7 ±2. 5 is excellent ease of use; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate(7 days To assess the ease of use by patients assessments)
- Mean (median) clinician assessment of exudate management on 5-point Numerical Rating Score (NRS) at day 7 ±2 and at any npSIMS replacement.(7 Days)
- Mean (median) days longevity of the chemical vacuum source up to day 7(7 Days)
- Presence or absence of blisters on day 7 ±2(7 days)
- Mean (median) wound pain score using a 0 -10 NRS (numerical rating score) by the study participant each day up to day 7±2. 10 is worst imaginable pain; 0 is no pain.(7 days)
- Mean (median) ease of use score from clinicians on 5-point NRS (numerical rating score) assessed at day 7 ±2. 5 is excellent ease of use; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate(7 days)
- Frequency of adverse events (non-device related, and device related) up to day30 ±2(30 Days)
- Mean (median) score of overall clinician acceptability of the NPWT system (pump & dressing) on 5-point NRS assessed at day 14 ±2. 5 is Excellent incision management system; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate(14 days)