NCT06255990招募中不适用
Clinical and Histological Study of a Novel Dermal Substitute, NovoSorb® BTM, Used in the Treatment of Full-thickness Skin Defects
University Children's Hospital, Zurich4 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Skin elasticity after 1year post-transplantation
研究概览
简要总结
The goal of this observational study is to compare a novel dermal substitute to a the current standard procedure in the treatment of full thickness skin defects.
The main questions aim to answer are:
• Is the skin elasticity treated with the novel dermal substitute better than the skin elasticity treated with the current standard procedure Participants skin elasticity will be measured by Cutometer® MPA-580 assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 1 to 75 years
- •Full-thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a STSG:
- •Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans or similar condition
- •Reconstructive cases (elective surgery): e.g. scar formation after burn injury, giant congenital nevus, defect after removal of skin tumor, skin defect due to other surgical procedures
- •Documented medical treatment decision of covering the full-thickness skin defects with either the two-step BTM/STSG procedure or with STSG alone or by using both techniques on different wound areas
- •Informed consent by patients/parents or other legal representative
排除标准
- •Infected wounds needing surgical procedure other than a dermal template
- •Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin disease, any kind of congenital defect of metabolism including diabetes)
- •Previous enrolment of the patient into the current study
- •Adolescent/Adult patients or in case of children their parents/legal representatives unable to comply with the study protocol
- •Adolescent/Adult patients or in case of children their parents/legal representatives having insufficient knowledge of local language
- •Pregnant or breast feeding females
结局指标
主要结局
Skin elasticity after 1year post-transplantation
时间窗: 1 year post-transplantation
Comparison of skin elasticity of treated skin versus adjacent normal skin
次要结局
- Histological staining(within 1 year after skin transplantation)
- Change of quality of life within one year after skin transplantation(within 1 year after skin transplantation)
- Photographical assessment(within 1 year after skin transplantation)
- Skin color assessment(within 1 year after skin transplantation)
- Immunohistochemical analyses(14-21 days after BTM transplantation)
研究者
研究点 (4)
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