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Pore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease

Pilonidal Sinus Clinical Trial

Official title:
Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease

Clinical Trial 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.

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00493493
Study type Interventional
Source Matino, James, M.D.
Contact James J Matino, MD
Phone 860-249-8595
Email jimanderin@yahoo.com
Status Recruiting
Phase N/A
Start date January 2007
Completion date June 2008
View Details
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