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Sponsors and Collaborators: |
Matino, James, M.D. LifeCell |
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Information provided by: | Matino, James, M.D. |
ClinicalTrials.gov Identifier: | NCT00493493 |
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 |
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Pilonidal Sinus |
Procedure: surgery (Pore Excision, Curettage, and Injection of Cymetra) |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Any patient with pilonidal diseas
Contact: James J Matino, MD | 860-249-8595 | jimanderin@yahoo.com |
United States, Connecticut | |
St Francis Hospital | Recruiting |
Hartford, Connecticut, United States, 06105 |
Principal Investigator: | James J Matino, MD | Surgical Group,PC |
Study ID Numbers: | Pilonidal/Cymetra |
Study First Received: | June 27, 2007 |
Last Updated: | June 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00493493 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cymetra |
Pilonidal Sinus Cysts |
Neoplasms Pilonidal Sinus Cysts |