Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-04 @ 8:51 AM
Study NCT ID:
NCT00493493
Status:
UNKNOWN
Last Update Posted:
2007-06-28
First Post:
2007-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease
Sponsor:
Matino, James, M.D.
Organization:
Study Overview
Official Title:
Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic pilonidal disease is a common problem with no ideal treatment. This is a prospective study that will evaluate the results of surgical pore excision, curettage, and injection of a regenerative tissue matrix, Cymetra, on patients with chronic pilonidal disease.
Detailed Description:
In addition, the study will evaluate the credibility and reproducibility of results within other surgeons trained to perform the procedure. Data collection will focus on post-operative wound failure, infection ratwes, analgesic requirements, time lost from work or school, wound care requirements, and 6 month recurrence rates. These outcomes will be compared to outcomes using conventional pilonidal surgical intervention using published data.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: