跳至主要内容
临床试验/NCT04999618
NCT04999618已完成4 期

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

Center for Vascular Pathology, Moscow1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

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

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)

Active Comparator

干预措施: Haemoblock (Drug)

Group without Haemoblock (B)

Placebo Comparator

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)

研究者

发起方
Center for Vascular Pathology, Moscow
申办方类型
Other
责任方
Sponsor

研究点 (1)

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