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临床试验/NCT03907111
NCT03907111已完成不适用

Develop the Biologic-fibrotic Dressing on War Open Bleeding Wounds for Hemostasis.

Tri-Service General Hospital0 个研究点目标入组 10 人开始时间: 2015年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
主要终点
Time to Hemostasis

研究概览

简要总结

This study recruited 10 subject participants to compare the hemostasis gauze made by chitosan with traditional cotton gauze to see which one is better in bleeding time, bleeding volume, wound infection and wound healing speed when it is used in open wound treatment.

详细描述

open wound bleeding and infection care policy development is focusing on efficiency to strengthen internal bleeding, pain, avoidance of infection and promoting wound healing wound. With the changes in the social environment, people caring for hemostasis and wound healing have become increasingly demanding. Presently, studies generally aim to stop the bleeding using trauma care technology and functional capabilities combined with each other as well as inhibit lower infection and can also help assist healing wounds care strategy for the protection of human lives. Therefore, the goal of the plan is to establish new care strategies on open wounds infection to stop the bleeding and to improve the health and safety of the people. The researchers will choose the general biological hemostatic gauze to conduct clinical trials comparing the clinical hemostasis focusing on bleeding time, wound infection in the wound and the wound bacteria penetrating situations in the hope to build a better strategy in rapid hemostasis and wound infection care strategy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients need laparotomy, with the expected wound size bigger than 5 cm in length and 2 cm in width.

排除标准

  • Have history of allergy to shrimp, crab and other chitins.
  • Patients with blood clotting disorders
  • Vulnerable group
  • Patients with unstable vital sign

研究组 & 干预措施

Chitosan gauze

Experimental

100cm^2 Gauze made by chitosan material. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care.

干预措施: Chitosan Gauze (Device)

Traditional gauze

Placebo Comparator

100cm^2 Gauze made by traditional cotton yarn. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care.

干预措施: placebo (Device)

结局指标

主要结局

Time to Hemostasis

时间窗: one hour after the surgery

How many second it takes to stop bleeding

次要结局

  • Breeding volume(one hour after the surgery)
  • Relative light units difference(day0, day7 and day 14.)
  • size of the wound in millimeter(day1, day3, day 5, day7 and day14.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsu Sheng-Der

attending physician, department of traumatology

Tri-Service General Hospital

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