Single site randomised trial of fibrin tissue glue versus surgery in the treatment of pilonidal sinus - Fibrin glue versus surgery for pilonidal sinus
- Conditions
- Pilonidal sinus
- Registration Number
- EUCTR2004-002065-20-GB
- Lead Sponsor
- Derbyshire NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
- male and female subjects with pilonidal sinus
- >18 years and <45 years
- only women taking adequate contraceptive precautions
- patientswith no history of allergy to any of the product contents of TISSEEL Kit saealant
- ability to provide valid informed consent
- patients who ahve no objection on moral/religious grounds of the product
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- women who are lactating
- women who are pregnant
- women of childbearing age who are unwilling to take adequate contraceptive
- patients with insufficient command of English to understand patient information or give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effectiveness of fbrin tissue glue with standard surgical techniques in the treatment of pilonidal sinus;Secondary Objective: ;<br> Primary end point(s): - reduction in pain<br> - healing rate<br> - return to normal activities<br> - recurrence of pilonidal diease<br> - complications of glue compared to surgery<br>
- Secondary Outcome Measures
Name Time Method