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临床试验/CTRI/2022/09/046040
CTRI/2022/09/046040已完成未知

An Open-Label Pilot Study to Evaluate the Safety and Efficacy of Zip-Stitch Surgical Wound Closure Device in the Closure of Uncontaminated Minor Lacerations

Simplified Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Patients with Low Tension Laceration
  • 2. Requires suture closure as the standard of care for simple straight wounds on trunk extremities or face.
  • 3. Patients who provide a agree to abide by the study requirements

排除标准

  • 1. Pregnant and lactating women
  • 2. Known personal or familial history of scar hypertrophy
  • 3. Known or suspected allergies or hypersensitivity to materials used in device
  • 4. Atrophic skin deemed clinically prone to blistering.
  • 5. Wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions contaminated/dirty wounds
  • 6. Wounds that require deep dermal closure using sutures.
  • 7. Known or suspected psychological problems or aggressiveness that indicates that the subject might try to remove the device during the treatment period.
  • 8. Ongoing treatment with cytostatic.
  • 9. Known or suspected diagnosis of severe anorexia.
  • 10. Currently participating or have participated in any other clinical investigation in the past 2 weeks

研究者

发起方
Simplified Healthcare Pvt Ltd

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