Pilonidal Sinus Disorder Clinical Trial
Official title:
Treatment of Pilonidal Sinus Disease Using Surgiflo as a Sealant: A New Concept
| Verified date | December 2015 |
| Source | Mansoura University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Egypt: Institutional Review Board |
| Study type | Interventional |
Assessment of surgiflo injection for treating pilonidal sinus disease
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | November 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 14 Years to 45 Years |
| Eligibility |
Inclusion Criteria: Patients included in the study had simple midline PS with single or multiple tracts and no lateral extensions. Recurrent cases of PS after previous surgery were also included in the study Exclusion Criteria: We excluded from the study patients with severe scarring at the natal cleft due to previous surgery or infection and patients with signs of an acute abscess. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Hosam Elbanna | Mansoura | Dakahlia |
| Lead Sponsor | Collaborator |
|---|---|
| Mansoura University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence of the condition | number of patients presenting with recurrent pilonidal sinus | 2 years | No |
| Secondary | Complications of the procedure | number of patients presenting with complications after injection of surgiflo | 2 years | Yes |