A Randomized, Controlled, Post-market Clinical Investigation to Evaluate Zip Surgical Skin Closure Device in Comparison of Using Standard of Care Sutures for Laceration Repair in Pediatrics and Adults in an Accident and Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Treatment time
研究概览
简要总结
The Zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation. The investigation is designed to evaluate the time and cost savings and the satisfaction and outcomes of the Zip device compared to conventional sutures. The subjects will be randomly assigned at a 1:1 ratio to either the Zip Surgical Skin Closure Device group or the Standard of Care sutures group. The investigation consists of one screening/baseline visits at day 0 where the subject will be treated with either the Zip device or sutures, and thereafter two follow up telephone calls at day 10 and day 30. The Zip device/sutures will be removed prior the first follow up call day 10. The duration of the investigation is estimated to 5 months, including a 4-month recruitment period and 1-month follow up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 4 and above at the time of laceration repair.
- •Require suture closure as standard of care for simple straight wounds on trunk, extremities or face.
- •Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
- •Subject and legal representative(s) (if a pediatric subject) are willing and able to comply with the investigational device removal and meet the follow up requirements.
- •Subject and legal representative(s) (if a pediatric subject) have been informed of the nature, the scope and the relevance of the study.
- •Subject and legal representative(s) (if a pediatric subject) have voluntarily agreed to participation and have duly signed the Informed Consent Form.
排除标准
- •Known personal or familial history of scar hypertrophy.
- •Known or suspected allergies or hypersensitivity to non-latex skin adhesives.
- •Atrophic skin deemed clinically prone to blistering.
- •Wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions ("dirty wounds").
- •Wounds that require deep dermal closure using sutures.
- •Known or suspected mental problems and/or aggressiveness that indicates that the subject might try to remove the device during the treatment period.
- •Ongoing treatment with cytostatic.
- •Known or suspected diagnosis of severe anorexia.
- •Participating in any other clinical investigation.
- •Known health condition that would affect healing in the opinion of the investigator.
- •Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment.
结局指标
主要结局
Treatment time
时间窗: Day 0
The primary endpoint in this clinical investigation is the mean difference in time to wound closure, for the two treatment methods used. These include total treatment time and duration of period starting from the preparation of procedure until protective wound dressing is applied, and including whether or not anesthesia and/or sedation was used when comparing the Zip Surgical Skin Closure Device and the standard of care closure suturing.
次要结局
- Objective evaluation on photographs using Wound Evaluation Score (WES)(Day 0, Day 10 (+/- 2 days), Day 30 (+/- 2 days))
- Visual Analog Scale (VAS) for pain(Day 0 and Day 10 (+/- 2 days))
- Subject satisfaction(Day 30 (+/- 2 days))