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Clinical Trials/ISRCTN56652573
ISRCTN56652573
Completed
Not Applicable

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 sites40 target enrollmentSeptember 29, 2006
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Enrollment
40
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 29, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • •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)

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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