USE OF 3D PRINTED SKIN AS SKIN GRAFT IN CHRONIC NON-HEALING ULCERS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The primary outcome of the study will be :
研究概览
简要总结
The 3D printed skin grafts are made up of xenogenic skin polymerized with biological polymers lika Poly- Vinyl Alcohol. These grafts contains skin specific extracellular matrix which helps the healing of the wound if applied to site of injury. The extracellular matrix will accelerate the healing by attracting the cells and facilitating the binding of platelets to the injured site. As the diabetic wounds are most complicated wounds and have problems of healing due to different reasons; we are targeting these wounds to check the efficacy of the 3D printed skin graft. Hence this study is designed for evaluation of the efficacy of formulated artificial skin for diabetic wound uclers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •The 3D-printed skin grafts are made up of xenogenic skin composed of extracellular matrix.
- •This graft will be sterilized and used on the wounded area as a treatment.
排除标准
- •All the patients who do not follow up in OPD.
- •Patients with diabetic foot ulcers undergoing amputation.
- •Patients with immunocompromised status.
- •Patients with osteomyelitis or gangrenous ulcers.
- •All the patients who do not give consent for the study.
结局指标
主要结局
The primary outcome of the study will be :
时间窗: 4 to 8 weeks
1. Acceptance of the skin graft
时间窗: 4 to 8 weeks
2. Wound healing rate
时间窗: 4 to 8 weeks
3. Incidence of wound closure
时间窗: 4 to 8 weeks
次要结局
- Safety & Tolerability(Quality of Wound Healing)
研究者
Dr Vaishali Gaikwad
Dr. D. Y. Patil Medical College, Hospital and Research Centre, Kadamwadi, Kolhapur