Pore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Matino, James, M.D..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Matino, James, M.D.
Collaborator:
LifeCell
Information provided by:
Matino, James, M.D.
ClinicalTrials.gov Identifier:
NCT00493493
First received: June 27, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pilonidal Sinus |
Procedure: surgery (Pore Excision, Curettage, and Injection of Cymetra) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease |
Further study details as provided by Matino, James, M.D.:
Primary Outcome Measures:
- wound failure, time lost from work or school, analgesic requirements, recurrence rates [ Time Frame: 6 months ]
Secondary Outcome Measures:
- infection rates, wound care requirements [ Time Frame: 6 months ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | June 2008 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Any patient with pilonidal diseas
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493493
Contacts
| Contact: James J Matino, MD | 860-249-8595 | jimanderin@yahoo.com |
Locations
| United States, Connecticut | |
| St Francis Hospital | Recruiting |
| Hartford, Connecticut, United States, 06105 | |
Sponsors and Collaborators
Matino, James, M.D.
LifeCell
Investigators
| Principal Investigator: | James J Matino, MD | Surgical Group,PC |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00493493 History of Changes |
| Other Study ID Numbers: | Pilonidal/Cymetra |
| Study First Received: | June 27, 2007 |
| Last Updated: | June 27, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Matino, James, M.D.:
|
Cymetra |
Additional relevant MeSH terms:
|
Pilonidal Sinus Cysts Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013