NCT05234632终止不适用
A Prospective Study to Evaluate the Safety and Performance of PICO 14 in the Management of Acute and Chronic Wounds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Delivery of Nominal -80mmHg Negative Pressure
研究概览
简要总结
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot ulcers), dehisced surgical wounds and closed surgical incisions. The study comprises the Post Market Clinical Follow-up (PMCF) for a new variant of an established product. PICO 14 is based on another dressing called PICO.
The primary objective is to evaluate functional performance of PICO 14 through verification of delivery of negative pressure and wound exudate management.
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
- 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.
- •Closed Incisions ONLY:
- •Subject has a suitable, closed surgical incision which the clinician considers is suitable for PICO therapy, where it is expected that the therapy will be applied for up to 14 days.
- •Any closed surgical incision in a patient in which the patient is deemed high risk of developing surgical site infection (SSI) in the opinion of the investigator.
- •Chronic wounds ONLY:
- •Patients with any chronic wound* which the treating clinician deems is suitable for management with single-use disposable NPWT where it is expected that the therapy will applied for up to 28 days.
- •*Chronic wound in this study is defined as any wound of less than three months duration that is not healing after 4 weeks of standard care and having addressed the underlying cause.
- •Dehisced surgical wounds ONLY:
- •Patients with dehisced wounds in which the clinician believes is suitable for PICO therapy where therapy is expected to be applied for up to 28 days.
- •*Wound dehiscence is a surgical complication in which two sides of a surgical incision separate and rupture along the incision, dehiscence typically is diagnosed after 2-3 days postsurgery and up to a month with more complicated surgeries
排除标准
- •Contraindications (per the PICO 14 Instructions for use [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 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, preexisting 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 who have participated previously in this clinical trial
- •Subjects with a history of poor compliance with medical treatment.
- •Malignant wounds, open abdomen, wounds which have been previously managed with NPWT in the previous four weeks.
- •Pregnancy.
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- •Presence of infection as determined by the clinical signs and symptoms (International wound infection).
结局指标
主要结局
Delivery of Nominal -80mmHg Negative Pressure
时间窗: Day 30
Delivery of nominal -80mmHg negative pressure over the treatment period was measured by download of the built-in data chip from the PICO 14 devices to collect NPWT delivery status. This data was summarized to provide the average negative pressure delivery overall and for both closed incisions and chronic/dehisced surgical wounds.
Exudate Management: Occurrence of No Exudate Leaks
时间窗: Up to 30 Days
Exudate management was measured by the number of participants with no exudate leaks identified by the clinician at any point over the treatment period, up to 30 days.
次要结局
- Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only(Day 14 and Day 30)
- Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only(Day 7, Day 14, and Day 30)
- Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only(Day 7, Day 14, and Day 30)
- Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only(Day 7, Day 14, and Day 30)
- Level of Pain - Visual Analog Score (VAS): Closed Incisions Only(Up to 14 Days)
- Patient Satisfaction During Wear - Performance: Closed Incisions Only(Day 7, Day 14, and Day 30)
- Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only(Day 7, Day 14, and Day 30)
- Ease of Application and Removal: Closed Incisions Only(Up to 14 days)
- Dressing Wear Time: Closed Incisions Only(Up to 14 days)
- Dressing Conformability: Closed Incisions Only(Up to 14 days)
- Number of Dressings Used: Closed Incisions Only(Up to 14 days)
- Reason for Dressing Change: Closed Incisions Only(Up to 14 days)
- Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Closed Incision Only(Day 14)
- Number of Participants With Clinical Infection: Chronic and Dehisced Surgical Wounds Only(Day 0, Day 7, Day 14, Day 21, and Day 28)
- Appearance of the Wound by Size: Chronic and Dehisced Surgical Wounds Only(Screening and Day 28)
- Appearance of the Wound by Depth: Chronic and Dehisced Surgical Wounds Only(Screening and Day 28)
- Appearance of the Wound by Presence of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only(Screening and Day 28)
- Appearance of the Wound by Type of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only(Screening and Day 28)
- Condition of Peri-Wound Skin Assessed Through Visual Inspection at Day 0, Day 7, Day 14, Day 21, and Day 28 Days: Chronic and Dehisced Surgical Wounds Only(Day 0, Day 7, Day 14, Day 21, and Day 28)
- Appearance of the Wound by Necrotic Tissue Amount: Chronic and Dehisced Surgical Wounds Only(Screening and Day 28)
- Appearance of the Wound by Granulation Tissue: Chronic and Dehisced Surgical Wounds Only(Screening and Day 28)
- Appearance of the Wound by Epithelialization: Chronic and Dehisced Surgical Wounds Only(Screening and Day 28)
- Appearance of the Wound by Level of Exudate: Chronic and Dehisced Surgical Wounds Only(Screening and Day 28)
- Appearance of the Wound by Presence of Exudate: Chronic and Dehisced Surgical Wounds Only(Screening and Day 28)
- Percentage Change in Area of Wound: Chronic and Dehisced Surgical Wounds Only(Day 7, Day 14, Day 21, and Day 28)
- Percentage Change in Volume of Wound: Chronic and Dehisced Surgical Wounds Only(Day 7, Day 14, Day 21, and Day 28)
- Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds Only(Up to 28 days)
- Patient Satisfaction During Wear - Performance: Chronic and Dehisced Surgical Wounds Only(Day 14 and Day 28)
- Patient Satisfaction During Wear - Interference With Daily Living: Chronic and Dehisced Surgical Wounds Only(Day 14 and Day 28)
- Ease of Application and Removal: Chronic and Dehisced Surgical Wounds Only(Up to 28 days)
- Dressing Wear Time: Chronic and Dehisced Surgical Wounds Only(Up to 28 days)
- Dressing Conformability: Chronic and Dehisced Surgical Wounds Only(Up to 28 days)
- Number of Dressings Used: Chronic and Dehisced Surgical Wounds Only(Up to 28 days)
- Reason for Dressing Change: Chronic and Dehisced Surgical Wounds Only(Up to 28 days)
- Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Chronic and Dehisced Surgical Wounds Only(Day 28)
研究者
研究点 (6)
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