A Prospective Follow up Study to Assess Performance, Safety and Efficacy of the PICO 7 NPWT System for Surgically Closed Incision Sites and Skin Grafts.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 15
- 主要终点
- Functional clinical performance of the PICO 7 NPWT system through delivery of negative pressure
研究概览
简要总结
The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the purpose of continuing CE (Conformité Européene) Mark approval in accordance with MEDDEV 2.12-2
详细描述
Although evidence exists which supports the positive effects of NPWT on take of skin grafts and flaps, there is limited evidence in relation to single-use systems such as PICO. Most previous studies have used traditional NPWT systems as part of their design. Though the technical applications of the traditional and newer single-use systems are comparable it is possible that some of the features of the latter may influence clinical outcomes. In addition to the limitations highlighted above, the cited studies have seldom assessed the ease of management and acceptability of NPWT systems. Although clinical outcomes may be considered paramount, these usability factors could also play a key role in ensuring compliance with negative pressure protocols.
Although evidence exists which supports the positive effects of NPWT on take of skin grafts and flaps, there is limited evidence in relation to single-use systems such as PICO. Most previous studies have used traditional NPWT systems as part of their design. Though the technical applications of the traditional and newer single-use systems are comparable it is possible that some of the features of the latter may influence clinical outcomes. In addition to the limitations highlighted above, the cited studies have seldom assessed the ease of management and acceptability of NPWT systems. Although clinical outcomes may be considered paramount, these usability factors could also play a key role in ensuring compliance with negative pressure protocols.
The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the purpose of continuing CE (Conformité Européene) Mark approval in accordance with MEDDEV 2.12-2.
The PICO system has recently been updated with minor modifications that make the system silent during wear. S & N also wish to collect PMCF data in the indications of knee and abdominal incisions in order to make retrospective comparisons with data previously collected for these indications.
The aim of this study is therefore to assess whether the PICO 7 system is a safe and effective therapy for surgically closed incisions, skin grafts and flaps. Effectiveness will be defined by the ability of the system to deliver negative pressure and handle exudate and by percentage of successful skin graft or flap survival at Day 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Open
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
- •Subject has a suitable, closed abdominal or knee surgery incision skin flap or skin graft (STSG, meshed or non-meshed) (if there is more than one incision then the clinician should choose the one which in their opinion is most suited to PICO therapy), that fits under the absorbent dressing area of the appropriate PICO 7 dressing supplied.
排除标准
- •Contraindications (per the PICO 7 IFU) 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 clinical trial 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.
- •Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).
- •Subjects with incisions or skin grafts that are actively bleeding unless haemostasis has been achieved (to be confirmed during surgery).
- •Subjects with infected skin grafts or incisions at the time of surgery (except for those with perforated bowel or peritonitis).
- •Subjects who have participated previously in this clinical trial
- •Subjects with a history of poor compliance with medical treatment.
- •Subjects with skin grafts to correct pressure ulcers where compression therapy is needed for healing (based on clinicians expertise).
- •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
Single prospective intervention
干预措施: Negative Pressure Wound Therapy (Device)
结局指标
主要结局
Functional clinical performance of the PICO 7 NPWT system through delivery of negative pressure
时间窗: 7 Days
Negative pressure maintenance at nominal 80 mmHg as assessed as the average of the negative pressure values recorded by the device microchip
Functional clinical performance of the PICO 7 NPWT system through wound exudate management
时间窗: 7 Days
Number of NPWT systems with no occurrence of exudate leaks as assessed through a combination of leakage alert data from device microchip and/or clinical data on any leakage observed during the dressing wearing period resulting or not, in an unplanned dressing change
Composite Clinical Success
时间窗: 7 Days
Composite Clinical Success (CCS) defined as a binary variable (1/0) (1 if both of the following are true and 0 if at least one of the two is false): A. Nominal pressure is in the interval 80mmHg ± 7mmHg B. No leakage
次要结局
- Visual inspection of peri-wound skin condition(30 Days)
- Visual Analog Scale (VAS) - pain(30 Days)
- Number of participants with incidence of Surgical Site Complications (SSC) - dehiscence (superficial/deep etc.), seroma, necrosis, hematoma, suture abscess(30 Days)
- Percentage of successful skin graft take or flap survival at Days 7, 14 and 30(30 Days)
- Dressing wear time in days(30 Days)
- Number of participants with incidence of Surgical Site Infection (SSI) - Superficial, deep. [CDC criteria](30 Days)