Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns - A Prospective Single Arm, Safety and Efficacy, Open Labeled Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Burn wound healing
研究概览
简要总结
Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns. A prospective, single arm, safety and efficacy, open labeled multi-center study
详细描述
The SpinCare is an electrospinning portable device intended for the external treatment of burns and wounds. The SpinCare is the first made on the spot, bed side, and completely personalized dressing system; with excellent coverage of all size, shapes and difficult contours. The nano-fibrous dressing mimics the structure of natural body tissue and creates excellent medium for tissue repair and healing.
The objective of this study is to evaluate the performance, safety and efficacy of the SpinCare System in the treatment of superficial to intermediate partial thickness burns.
The study included 3 sites. Adult patients with superficial to intermediate partial thickness burns (second degree superficial to intermediate) of up to 10% TBSA (Total Body Surface Area); with an independent burn of up to 5% TBSA.
A prospective single arm, safety and efficacy, open labeled, multi-center study for the treatment of partial thickness burn wounds not considered for surgery using the SpinCare System.
44 patients enrolled in the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old at enrolment. Both genders.
- •The patient has partial thickness burn wounds (second degree superficial to intermediate) of up to 10% TBSA; of which the target wound for treatment is of up to 5% TBSA or up to 300cm
- •Presenting at the emergency room within the first 24-48 hours post-injury.
- •Patient's wound is defined as a partial thickness burn for conservative treatment (superficial to intermediate second degree).
- •Patient underwent cleansing/debridement of initial burn before applying the dressing
- •The patient is able and willing to comply with study procedures and give written informed consent prior to enrollment in the study
排除标准
- •Any known or suspected systemic infection
- •Any known sensitivity to components/products used in this study
- •Any active, uncontrolled, progressive or untreated malignancy
- •Use of penicillamine, corticosteroid or immunosuppressive medication within two months prior to enrollment or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation
- •Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders
- •Major dermatological disorders such as: psoriasis, pemphigus, Steven Johnson, etc.
- •Patients with burns larger than 10% TBSA
- •Patients with burns up to 10% TBSA but no target wound of up to 5% TBSA or up to 300cm2
- •Patients suffering from electrical or chemical burns.
- •Patients suffering from frostbites.
- •Patients suffering from burn wounds that are third degree or full thickness.
- •Patients suffering from burn wounds in the head, neck or genital areas
- •Female patients who are pregnant or nursing
- •Psychiatric patient.
- •Participation in another clinical trial within 30 days prior to the Screening Visit
结局指标
主要结局
Burn wound healing
时间窗: 21 days
Wound healing and re-epithelialization on day 21. The burn will be considered healed when at least 95% of the total area is re-epithelialized and no scabs exist.
次要结局
- Dermal safety test (erythema and edema)(Every time the SpinCare dressing is delivered up to 21 days after initial dressing)
- Pain as assessed by VAS(21 days)
- Number of participants having an infection at the burn wound.(Up to 21 days after initial application of the dressing)
- Ease of use(Every time the SpinCare is used up to 21 days after initial application of the dressing)