Skin and Connective Tissue Diseases: Pilonidal sinus Skin and Connective Tissue Diseases Pilonidal sinus
Conditions
Interventions
Randomised Controlled Trial. Patients that present with pilondial sinus at outpatient clinic will be invited to participate in the study. Forty patients will be recruited. Having given informed consen
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Eligibility
Sex/Gender
All
Inclusion 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. Inclusion criteria: 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in Pain 2. Healing rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Added September 2008: Recurrence, infection, return to work and cost. | — |
Countries
United Kingdom
Outcome results
None listed