NCT00389753撤回不适用
A Prospective, Randomized, Double Blinded Controlled Clinical Trial of the Aruba Aloë Formula F-BC-096 in the Treatment of Split Thickness Donor Sites After Wound Closure
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Scar assessment after 1 month
研究概览
简要总结
Comparison between use of Aruba Aloë formula F-BC-096 and control.
详细描述
Patients with two equal donor sites will be selected for inclusion. After wound healing one donor site will be treated with Aruba Aloë Formula F-BC-096 while a control product will be applied to the second site.
If pressure garments are applied they must be equal for both donor sites. During follow-ups objective methods will be used to evaluate elasticity and colour of the scar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have two similar donor sites, identical in depth and wound treatment.
- •Healing time of both donor sites may differ by 3 days maximum.
- •Flux values determined by Laser Doppler Imaging before commencement of the therapy must be approximately similar.
- •If possible, the donor sites to be compared must have the same location.
- •Patient compliance with therapy in relation to the protocol is necessary. In case of pediatric patiënts this depends on collaboration of the parents.
- •For the two donor sites to be compared, the entire after-treatment concerning pressure garments or eventual silicone sheets must be equal for both donor sites.
- •Patients must be available for regular and necessary follow-up.
- •Possibility to finish all measurements during follow-up visits.
- •Written authorisation of the patient, family or parents is required.
排除标准
- •Donor sites are not similar (not identical in: depth, wound treatment, healing time and flux values)
- •Children requiring sedation for LDI of donor sites
- •Not following the complete treatment schedule or missing some evaluations during the follow-up period
- •Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
- •Patient has participated in another study utilizing an investigational drug or device within the previous 30 days
- •Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this study
- •Patients wish to terminate the study
- •No informed consent before start of the trial
结局指标
主要结局
Scar assessment after 1 month
次要结局
- Scar assessment 3, 6 and 12 months after wound closure
研究者
研究点 (1)
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