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

Completed

• Conditions: Skin and Connective Tissue Diseases: Pilonidal sinus; Skin and Connective Tissue Diseases; Pilonidal sinus

• Registration Number: ISRCTN56652573
• Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Reduction in Pain<br>2. Healing rate.

Secondary Outcome Measures

Name	Time	Method
Added September 2008:<br>Recurrence, infection, return to work and cost.