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NCT00493493 Clinical Trial

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 Details — Status: Recruiting

Administrative data
NCT number NCT00493493
Other study ID # Pilonidal/Cymetra
Secondary ID
Status Recruiting
Phase N/A
First received June 27, 2007
Last updated June 27, 2007
Start date January 2007
Est. completion date June 2008

Study information
Verified date June 2007
Source Matino, James, M.D.
Contact James J Matino, MD
Phone 860-249-8595
Email jimanderin@yahoo.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date June 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Any patient with pilonidal diseas

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• surgery (Pore Excision, Curettage, and Injection of Cymetra)

Locations
Country Name City State
United States St Francis Hospital Hartford Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Matino, James, M.D. LifeCell

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary wound failure, time lost from work or school, analgesic requirements, recurrence rates 6 months
Secondary infection rates, wound care requirements 6 months
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