NCT03628690Unknown不适用
A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture
BandGrip1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年7月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Complete wound closure
研究概览
简要总结
an unbalanced (2:1) randomized study comparing two methods of traumatic skin closure in an ER setting: BandGrip vs suture
详细描述
Up to 45 subjects at up to 2 study sites who present to the ER for treatment of a skin laceration will be consented and randomized to treatment with suture or BandGrip. Subjects will be followed for 30 days post treatment to assess cosmetic quality of wound healing, evidence of adverse events related to closure method, and speed and completeness of wound closure and removal of closure devices.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female age 18-
- •Subject presents to emergency room with at least one skin laceration that is assessed as requiring a suture closure on the trunk or extremities (excluding hands and feet).
- •The length of the laceration is less than or equal to 1.5 inches.
- •Subject is otherwise in good general health in the opinion of the investigator.
- •Subject must be willing to follow instructions for wound care provided by investigator and refrain from picking at the treatment device, applying topical medications to the wound, and swimming or soaking in a tub until BandGrip or the sutures are removed.
- •Subject agrees to return for follow-up evaluations.
- •Subject (or guardian) is able to comprehend and give informed consent for participation in this study.
排除标准
- •Significant multiple trauma (merely multiple wounds are allowed).
- •The wound involves a lower limb with critical limb ischemia.
- •Concurrent acute infection requiring intravenous or oral antibiotics.
- •Bleeding, coagulation and or clotting disorders.
- •Subject is on dialysis.
- •Inflammatory and or allergic diseases or conditions of the skin: for example, psoriasis, eczema or dermatitis.
- •History of drug abuse.
- •Chronic use of oral steroids or immunosuppressants.
- •Known personal or family history of keloid or hypertrophic scarring.
- •History of abnormal wound healing.
- •Burst stellate lacerations due to a crush or hard blow.
- •Animal or human bite or scratch.
- •Wound is in the head, hands or feet or in a high skin tension area or across an area of increased skin tension on a joint.
- •Investigator objects to a patient's involvement in the study protocol.
- •Known allergy to components to BandGrip or suture material.
- •Known cognitive or psychiatric disorder.
- •Wound requiring debridement of devitalized or contaminated tissue.
- •Wound at site of active rash/skin lesion making evaluation difficult.
- •Previously treated wound or has failed to heal.
- •Puncture wound.
研究组 & 干预措施
BandGrip
Experimental
Topical skin closure device
干预措施: BandGrip (Device)
Standard Suture
Active Comparator
Standard sutures will be used for wound closure
干预措施: Suture (Device)
结局指标
主要结局
Complete wound closure
时间窗: 30 days post treatment
defined as continuous approximation of skin margins without need for reintervention .
次要结局
- Infection(10 and 30 days post closure)
- Subject satisfaction(30 days post closure)
- Pain/discomfort(index procedure and 10 days post closure)
- Time to wound closure and device removal(index procedure and 10 days post wound closure)
- Subject Satisfaction(30 days post closure)
- Physician satisfaction(index procedure)
- Wound comesis(10 and 30 days post closure)
- Wound Evaluation(10 and 30 days post wound closure)
研究者
研究点 (1)
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