Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493493
Status:
UNKNOWN
Last Update Posted:
2007-06-28
First Post:
2007-06-27
Brief Title:
Pore Excision Curettage and Injection of Cymetra for Pilonidal Disease
Sponsor:
Matino James MD
Organization:
Matino James MD
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:
None
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?:
None