NCT02012569已完成2 期
A Phase II Randomized, Controlled, Single Blind Study to Evaluate the Haemostatic Efficacy and Safety of TT-173 Applied in the Donor Site of Patients Undergoing Skin Graft
Thrombotargets Europe S.L1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Reducing the bleeding time in the donor site of skin grafting
研究概览
简要总结
The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the bleeding time in the donor site of skin grafting.
详细描述
As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety and efficacy of TT-113 in the donor site of sking grafting
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
- Double (Participant, Investigator)
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
- •Subjects who signed the informed consent.
- •Subjects that have to undergo a skin graft.
- •Subjects of both sexes older than 18 years.
- •Subjects that present a burn or traumatic skin injury affecting less than 30% of corporal surface.
- •Subjects with a platelet count not compatible with pathology.
- •Subjects who present haemogram results not indicative of any of the situations mentioned in the exclusion criteria.
- •Subjects who present biochemical results not indicative of any of the situations mentioned in the exclusion criteria.
- •Subjects who present coagulation parameters not indicative of any of the situations mentioned in the exclusion criteria.
- •Women of childbearing age who take contraceptive measures and are willing to maintain them until the end of follow up of this study.
- •Women of childbearing age who present a negative test pregnancy at the moment of study inclusion
排除标准
- •-Subjects with personal or family history of abnormal hemorrhagic episodes.
- •Subjects affected of any kind of congenital or acquired coagulopathies.
- •Subjects that present a burn or traumatic skin injury affecting more than 31% of corporal surface.
- •Subjects affected of any blood, heart or liver disease, chronic renal failure, severe chronic obstructive pulmonary disease, active oncologic process in the past three months, diabetes type I or who has suffered a stroke.
- •Subjects who experienced excessive bleeding after surgical procedures, childbirth or tooth extraction.
- •Subjects affected by any acute infectious disease.
- •Subjects affected of any systemic disease that may worsen the prognosis if any adverse effect occurs (decompensated type 2 diabetes mellitus, uncontrolled hypertension or severe systemic disease).
- •Subjects who should take antiplatelet therapies one week before and 48 hours after the surgery (AAS, trifusal, dipiridamol, clopidogrel, abciximab).
- •Subjects with known hypersensitivity or allergy to any component of the drug.
- •Subjects who consume abuse drugs excluding cannabis and its derivatives.
- •Subjects who are unable to follow or understand properly the instructions and requirements of the study.
- •Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators.
- •Subjects who participate or have participated in the past three months in another clinical trial with drug treatment.
- •Subjects that are the investigators, collaborators, nurses, center employees or any other person directly related to the development of the protocol.
- •Subjects who are positive to HIV or HCV serology, or who present active HBV infection.
- •Subjects who are pregnant or lactating.
研究组 & 干预措施
TT.173
Experimental
It is applied directly to the bleeding of the donor site
干预措施: TT-173 (Drug)
placebo
Placebo Comparator
It is applied directly to the bleeding of the donor site
干预措施: Placebo (Drug)
结局指标
主要结局
Reducing the bleeding time in the donor site of skin grafting
时间窗: 10 min
次要结局
- Safety and tolertability(1 month)
- Systemic absorption of the product(1 month)
- Immunogenicity(1 month)
研究者
研究点 (1)
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