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临床试验/NCT06558942
NCT06558942尚未招募不适用

A Study on the Application of Incisional Negative Pressure Therapy in Reducing the Risk of Infection in Animal Induced Injury Patients With Primary Wound Closure

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Wound infection (WI)

研究概览

简要总结

Animal injuries are a significant public health issue, with the most common being bites or scratches from cats and dogs. Every year, over 40 million people in China are bitten or scratched by cats and dogs, which can lead to wound infections and even systemic complications, with infection rates ranging from 10% to 80%. However, there is still no better way to reduce wound infection rates in current clinical studies and guidelines.

Incisional negative pressure wound therapy (iNPWT) is a new wound treatment technology developed in recent years. It creates a negative pressure environment on sutured or closed wounds, helps to fix the edges of the incision together, reduce lateral tension on the wound, stimulate blood perfusion at the edge of the wound, remove fluid from the wound, and act as an external pollution barrier. INPWT has been widely used for postoperative wound healing in surgery, but there is currently a lack of effective clinical trials on its ability to prevent wound infections caused by animal injuries and promote wound healing.

This study aims to apply iNPWT technology to the wounds of patients with rabies grade III exposure who underwent primary suturing, and compare it with wounds covered with ordinary gauze after previous primary suturing to determine whether it can help reduce postoperative incision infection rates and promote wound healing. This will provide high-quality clinical evidence for the widespread use of wound management in rabies grade III exposure patients in the future.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Limds injuries caused by animals, first or second animal injury to Grade III exposed patients, with deep wounds reaching the fat layer, tendons, and even penetrating injuries.
  • Patients with wounds>2cm and severe injuries that even require surgical treatment.

排除标准

  • Missing or incomplete follow-up data within 30 days.
  • Patients who have been infected with wounds or have been injured for more than 8 hours before seeking medical attention.
  • Acupuncture like wound (<2mm).
  • Patients with whole skin detachment.

结局指标

主要结局

Wound infection (WI)

时间窗: <4 weeks

The local skin of the wound appears red, swollen, hot, and painful, with or without systemic hyperthermia

次要结局

  • Delayed healing of wounds (DHW)(2-4 weeks)
  • Wound reprocessing (WR)(≤4 weeks)
  • other wound complication(≤4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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