EVALUATION OF THE SPINNER™ DEVICE FOR THE APPLICATION OF WOUND DRESSING: TREATMENT OF SPLIT SKIN-GRAFT DONOR SITES. A Prospective, Safety and Efficacy, Open Labeled, Two Arms, Randomized, Multi Center, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 5
- 主要终点
- Change in dermal safety (Draize) score
研究概览
简要总结
Evaluation of safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW)
详细描述
The SPINNER is a hand held, portable electro-spinning device that produces personalized in-situ nanofiber dressings for the treatment of external burns and wounds.
The dressing has non-adherence, high absorbance, bacterial protection, easy and pain-free peel characteristics and shows excellent conformability and optimal coverage of the wound.
The objective of this study is to evaluate the safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW) at size of 10-200 cm2.
The study will include five sites in Israel:
Sheba Medical Center, Tel Hashomer RambamMedical Center, Haifa Kaplan Medical Center, Rehovot Souraski Medical Center, Tel Aviv Beilinson Medical Center, Petach Tikva
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is ≥ 18 years old at enrolment. Both genders.
- •Patients with donor site wound, size of 10-200 cm2, located in the thigh after partial thickness skin-graft
- •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
- •Use of penicillamine, corticosteroid or immunosuppressive medication within two months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, 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.
- •Patients undergoing repeat skin graft harvesting at the same donor site
- •Patients with burns of more than 15% TBSA
- •Requires immersion hydrotherapy at any time during study participation
- •Bleeding disorders
- •Skin disorders such as psoriasis, pemphigus, Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), pyoderma gangrenosum and other exfoliative disorders
- •Terminal patients
- •Prisoners
- •Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception
- •Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
- •Psychiatric patient.
研究组 & 干预措施
SPINNER
All patients in this arm will be treated with the SPINNER .
干预措施: SPINNER (Device)
JELONET or IBU-Biatain
All patients in this arm will be treated with JELONET/IBU Biatain dressing, regarded as the standard of current care for split-skin donor-site wounds.
干预措施: JELONET / IBU Biatain (Device)
结局指标
主要结局
Change in dermal safety (Draize) score
时间窗: 1-21 days
Change in Draize score from procedure day to day 21
Change in wound healing
时间窗: 1-21 days
Change in wound healing in cm2 from procedure day to day 21
次要结局
- Assessment of pain(21 days)
- Assessment of infection(21 days)
- Ease of use(21 days)