NCT02807584已完成不适用
A Prospective, Open Study to Evaluate the Clinical Performance of a New Adhesive Foam Dressing in the Treatment of Partial Thickness Burns, Acute and Chronic Wounds.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system
研究概览
简要总结
This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative to traditional wound care methods.
Patients will be treated with ELECT for 14 days. Data relating to wound healing, the performance of the dressing and the opinion of the doctor will be collected.
The hypothesis of this study is that the ELECT foam adhesive dressing is 'fit for purpose' and will be effective at treating a variety of wounds.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be ≥1 years old
- •Males and females (females must not be pregnant and must use contraception if of child bearing potential)
- •Participant must have a partial thickness burn, acute or chronic wound that would benefit from the application of an advanced wound dressing to help facilitate moist wound healing
- •Presence of a suitable wound which can be treated with the available sizes of the ELECT Adhesive Foam Dressing (7.5cm x 7.5cm, 12.5cm x 12.5cm, 15cm x 15cm and 17.5cm x 17.5cm)
- •Participant is under the direct observation of the investigator for the duration of the study (i.e the participant's wound must not be treated by another clinician throughout the duration of the study).
- •The participant or the participant's legal representative is able to understand and is willing to consent to the study.
排除标准
- •Participants with a known history of poor compliance with treatment (including if the participant has a known , diagnosed emotional or neurological condition such as mental disorders/illnesses, mental retardation, drug or alcohol abuse, that would pre-empt their ability to understand and consent)
- •Participants who are unable to understand the aims and objectives of the study.
- •Participant is a prisoner.
- •Participants with a known sensitivity to any of the constituents of the evaluation products, including polyester, polyurethane, and acrylic adhesive
- •Participants with facial wounds as the reference wound
- •Participants with confirmed or suspected clinically infected reference wounds (unless wounds are being treated per standard protocol for wound infection)
- •Participant is likely to undergo foreseeable definitive surgery within 2 weeks from screening
- •Participants where a reference wound cannot be treated in isolation from other wounds
- •Participants who have participated in this evaluation previously and closed/100% healed, or have been withdrawn from the study, or any previous studies
- •Participant who are employees of Smith & Nephew group companies
研究组 & 干预措施
ELECT
Experimental
Adhesive Foam Dressing
干预措施: ELECT (Device)
结局指标
主要结局
Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system
时间窗: 14 days
using a wound imaging, measurement and wound documentation system
次要结局
- Duration of dressing wear(14 days)
- Assessment of exudate type and amount(14 days)
- Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale)(14 days)
- Percentage change in wound depth(14 days)
- The proportion of wounds that have 100% healed or closed by secondary intention.(14 days)
- Percentage change in wound volume(14 days)
- Assessment of Condition of the peri-wound skin(14 days)
- Assessment of the amount of tissue and skin colour(14 days)
- Reason for dressing change(14 days)
- Ease of application and removal of the ELECT dressing using the visual analogue scale(14 days)
- Clinician acceptability with dressing performance parameters(14 days)
- Assessment of infection/clinical signs of infection(14 days)
- Overall clinician acceptability with the new dressing(14 days)
- Safety in use - all adverse events that occur during the study will be recorded(14 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg UlcersVaricose UlcerNCT00349700Ruhr University of Bochum139
已完成
不适用
A Open Study to Evaluate the Performance of Dressing on Subject With High Risk of Skin BreakdownCritical IllnessNCT01354899Molnlycke Health Care AB24
已完成
不适用
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical PracticeAbrasionBurn, Partial ThicknessLacerationOncology WoundPressure UlcerLeg UlcerSurgical WoundDiabetic Foot UlcerNCT05148390BSN Medical GmbH36
已完成
不适用
Study of a New Dressing for Use With Topical MedicationsPsoriasisNCT00234728Teikoku Pharma USA, Inc.120
终止
不适用
Study To Assess Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal FatAbdominal FatMuscle StimulationNCT05388617Cynosure, Inc.16