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
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The frequency and severity of all treatment-related adverse events, during and after use of PHBV nanofibrous scaffold will be examined throughout the follow-up period. Adverse events will be assessed on a continuous basis
研究概览
简要总结
Traumatic wounds including surgicalwounds and diabetic ulcers are chronic and it causes a significant number of morbiditiesworldwide. These wounds are often called as hard-to-heal wounds. None of the currently available marketedbiomaterials for skin replacements possess all the ideal requirements of a skingraft. Despite the progress in woundmanagement strategies over the years, clinically available dermal substitutessuffer from some pitfalls like undesirable wound contraction, scar formation,poor angiogenesis and poor engraftment. This fact necessitates the development of a safe, easy to handle andcost-effective skin graft with better therapeutic efficacy. Biodegradable polymeric nanofibrous scaffoldshave been shown to be effective in accelerating full-thickness wounds. In thisproposed study, the potential of EnScaff in healing full-thickness wounds is tobe tested for the first time in a clinical setting. Participants in this studywill receive PHBV nanofibrous scaffolds (EnScaff) followed by regular observation for a period of 11weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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 investigator’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:
- •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.
结局指标
主要结局
The frequency and severity of all treatment-related adverse events, during and after use of PHBV nanofibrous scaffold will be examined throughout the follow-up period. Adverse events will be assessed on a continuous basis
时间窗: 1 week, 2 weeks, 3 weeks, 4, weeks, 5 weeks and 6 weeks post-implantation
次要结局
- Wound closure(The treatment period of each subject will be 6 weeks and follow up period of 5 weeks)