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临床试验/ISRCTN56652573
ISRCTN56652573已完成不适用

Single centre randomised study to discover whether fibrin glue is more effective than surgery in the treatment of pilonidal sinus

Record Provided by the NHSTCT Register - 2006 Update - Department of Health0 个研究点目标入组 40 人开始时间: 2006年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40

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

性别
All

入选标准

  • Patients with pilonidal sinus under the care of Consultant Surgeons within the Derby NHS Foundation Trust will be identified from GP referral letters to surgical outpatients. Patients will be approached on visiting outpatients. Patients will be given both verbal and written information to enable them to make an informed decision as to whether to proceed. Patients have the right to withdraw at any stage.
  • 1. Male and Female subjects with pilonidal sinus
  • 2. Patients > 18 years old
  • 3. Only women taking adequate contraceptive precautions
  • 4. Patients with no history of allergy to any of the product contents of Tisseel Kit sealant.
  • 5. Ability to provide valid informed consent.
  • 6. Patients who have no objections on moral/religious grounds to the product (Tisseel contains human fibrin and Aprotinin from cattle)

排除标准

  • 1. Women who are lactating
  • 2. Women who are pregnant
  • 3. Women of childbearing age who are unwilling to take adequate contraceptive precautions
  • 4. Patients with allergic diathesis or patients who have had previous exposure to aprotinin

研究者

发起方
Record Provided by the NHSTCT Register - 2006 Update - Department of Health

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