DOUBLE-SKIN: a New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology: a Randomised, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Preventing negative outcomes of postoperative infection
研究概览
简要总结
Laser treatment (LT) is the first-line treatment for Vascular Pathology. However even when LT is based on the selective photothermolysis it causes the first-degree burns. While being typically benign by affecting only the epidermis, or outer layer of skin, the burn site is remaining red, dry, and very painful. As Haemoblock contains nanoparticles of silver and is known for both bactericidal and bacteriostatic effects, it likely decreases the potential for infection postoperatively. Furthermore, after fibrin replaces the superficial structure "Hemoblock-albumin", the polyacrylate matrix is plasmolyzed which initiates the cascade of signals required for the tissue regeneration processes. Objective of the study was to examine the effect of the Regenerative Solution "Hemoblock" in lowering postoperative complications in children diagnosed with Vascular Pathology undergoing a laser surgery if delivered with transdermal patches.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, clinicians and the research team, completing baseline and follow-up assessments were masked to group allocation.
入排标准
- 年龄范围
- 6 Months 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed Vascular Pathology
排除标准
- •severe allergic reaction
研究组 & 干预措施
Group with Haemoblock (A)
干预措施: Haemoblock (Drug)
Group without Haemoblock (B)
干预措施: Placebo (Other)
结局指标
主要结局
Preventing negative outcomes of postoperative infection
时间窗: Early postoperative period and at 3 weeks
Validated scales
次要结局
- Preventing prolonged functional recovery(Early postoperative period and at 3 weeks)
