NCT02169362Unknown1 期
Phase I, Double-Blind, Randomized, Controlled Study to Demonstrate the Safety of Applying Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) to Acute Deep Partial Thickness Thermal Injuries
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 36
- 试验地点
- 16
- 主要终点
- Safety as measured by Adverse Events
研究概览
简要总结
The study will examine the safety of using a concentration of proteins from a patient's own blood, referred to as platelet rich plasma or (PRP) and applying it to a second degree burn wound.
详细描述
The objective of this trial is to demonstrate the safety of applying autologous PRP gel (Magellan® Bio-Bandage™) to acute deep partial thickness thermal burns in the first days after burn injury.
The Magellan® Bio-Bandage™ Burn Wound Care Kit is intended for the preparation and application of an autologous biological covering to deep partial thickness burn wounds to delay or minimize skin grafting requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent will be obtained prior to study participation
- •Male or female age ≥ 18 years of age or ≤ 86 years of age
- •Total burn wound measuring ≤ 25% TBSA
- •Burn wound area to be treated must be a deep partial thickness wound
- •Burn wound area to be treated must be ≤72 cm2 and surrounded by a perimeter of healthy skin
- •Able and willing to comply with the procedures required by the protocol. Subjects may be managed as either inpatient or outpatient.
- •If a female of childbearing potential, the subject must have a negative serum pregnancy test at screening
- •All subjects, male and female, must use acceptable method(s) of birth control for the duration of the study
- •Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):
- •Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry)
- •A partner who is physically unable to impregnate the subject (e.g., vasectomized)
- •Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to subject's cell concentrate administration
- •Intrauterine device (IUD), or
- •Double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)
排除标准
- •Conductive electrical, friction or chemical burns
- •Burns to the digits, head, genitalia, palms of hands, soles of feet, and face that are the only possible sites for treatment (subjects with burns elsewhere in addition to these sites may be enrolled in the study)
- •Burns that pose a risk to digits or limbs
- •Subjects who have gone into hemorrhagic shock following burn injury
- •Subject was medically treated for insulin-dependent or non-insulin-dependent diabetes mellitus prior to burn injury per subject medical history
- •Venous or arterial vascular disorder directly affecting a designated test area
- •Known immune deficiency disorder, either congenital or acquired
- •Chronically malnourished as determined clinically by the investigator. (Investigators are responsible for determining if subjects are chronically malnourished during the screening process. Investigators should take into consideration the following parameters: medical history and physical appearance, the subject's body mass index, and any significant laboratory findings)
- •Severe respiratory problems or concurrent head trauma at hospital admission, including inhalation injury requiring ventilator support
- •Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
- •Use of COX-1 and/or COX-2 inhibitors within 48 hours prior to treatment. Subjects must refrain from use of NSAIDs for five days after Visit
- •Any other acute or chronic concurrent medical condition(s) that, in the investigator's opinion, are a contraindication to study participation or limit the subject's life expectancy to < 6 months
- •Known or suspected hypersensitivity to Recothrom®
- •Concurrent participation in another clinical trial in which an investigational agent is used. (Subjects must not have been enrolled in another clinical trial within 30 days of enrolling in this trial)
- •Females who are pregnant or nursing or intend to become pregnant during the duration of the study
- •Burn wounds that occur over joints
- •Known allergies to silver, adhesive products or silicone.
- •Subjects with the following abnormal laboratory test levels:
- •Stage 4 or greater chronic kidney disease (eGFR < 30 mL/min
- •Hemoglobin < 10 g/dl
- •Thrombocytopenia < 100,000 platelets/µl.
- •Serum albumin level < 2.5 g/dl or > 30 g/dl at time of screening
- •Liver function*:
- •AST- Males and Females, >2.5 ULN
- •ALT- Males and Females, >2.5 ULN
- •Alkaline Phosphatase- Males and Females: >2.0 ULN
- •Total bilirubin- Males and Females >2.0 ULN
结局指标
主要结局
Safety as measured by Adverse Events
时间窗: Days 1 -365
The primary objective of this trial is to demonstrate the safety of applying autologous PRP gel to acute deep partial thickness thermal burns in the first days after burn injury. The primary endpoint of this study will be safety. Incidence of Adverse Events and/or Serious Adverse Events will be documented, along with time to wound closure.
次要结局
- Improved wound healing trajectory as compared to standard of care(Change will be assessed up to 365 Days)
- Increased rate of wound closure as compared to standard of care(Change will be assessed up to 365 Days)
- Reduced scarring, pain and pruritus(Change will be assessed up to 365 Days)
- Delay or minimization of skin grafting requirements following burn injury(Change will be assessed up to 35 Days)
- Improved Skin-Healing Quality(Change will be assessed up to 365 Days)
研究者
研究点 (16)
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