CTRI/2020/11/029284尚未招募1 期
A single center, open labeled, pilot study to evaluate the safety and efficacy of Poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) nanofibrous synthetic biodegradable skin graft for full-thickness wounds
SASTRA Deemed University0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Males / females 18 or older
- •2.Patients with full-thickness traumatic wounds, surgical wounds, diabetic wounds, post-debridement wounds of 1 to 10 cm 2
- •3.Ulcer free of all necrotic and infected soft tissue (based on clinical investigatorâ??s discretion).
- •4.Have no significant diseases or clinically significant abnormal laboratory values during screening
- •5.In case of diabetic subjects, with regular medical treatment for diabetes
- •6.Able to understand, communicate and sign the written informed consent form
- •7.Adequate hematology, biochemistry & urine laboratory values
排除标准
- •Any of the following is regarded as a criterion for exclusion from the study:
- •1. Patients showing impaired blood coagulation
- •2.Patients with hematopoietic, renal, immunological and dermatological diseases/disorders
- •3.History of psychiatric disorders
- •4.Recent history ( < 2 years) of alcoholism (alcohol abuse) or unlikely to refrain from excessive alcohol consumption during the study period
- •5.Smokers, who smoke more than 10 cigarettes per day and cannot refrain from smoking during the study period
- •6.Use of any recreational drugs or a history of drug addiction
- •7.Participation in another trial within 30 days of enrollment for this study
- •8.Women who are pregnant or are breast feeding
- •9.Subjects with positive HIV, HBV and HCV
研究者
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