Topical Treatment With Glucocorticoids to Prevent Hypertrophic Scars and Keloid Due to Central Venous Access in Children
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal
研究概览
简要总结
Most children with cancer need a central venous catheter. These catheters are typically placed on the anterior thorax, where the risk of hypertrophic scarring and keloid development is greatly enhanced. A significant part of the children who have survived childhood cancer are troubled by their scars.
Topical glucocorticoid treatment is known to induce a reduction of the collagen in the connective tissue.
The investigators hypothesize that treatment with topical glucocorticoids for one week before and three weeks after removal of a central venous catheter, will reduce the formation of hypertrophic scarring and keloid development in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children and adolescents who have a central venous catheter removed at the Childrens Department of Oncology at Aarhus University Hospital Skejby in the period from March 2010 to July 2011
排除标准
- •Known allergy towards plaster or fusidic acid
研究组 & 干预措施
Fucicort
干预措施: Betamethason-17-valerate and fusidic acid (Drug)
Fucidin
干预措施: Fusidic Acid (Drug)
结局指标
主要结局
scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal
时间窗: Twelve months
次要结局
- Judgement of the scar by Patient and observer scar scale after six months(six months)
- Judgement of the scar by Patient and observer scar scale after twelve months(twelve months)
- scars measured by the Vancouver Scar Scale six months after central venous catheter removal(six months)
研究者
Mette Møller Handrup
MD, PhD
Aarhus University Hospital