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

Not Applicable

• Conditions: Pilonidal Sinus

• Registration Number: NCT00493493
• Lead Sponsor: Matino, James, M.D.

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 Timeline

• Study Start: 2007-01
• Status Verified: 2007-06
• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-27
• Last Update Submitted: 2007-06-27
• Study First Posted: 2007-06-28
• Last Update Posted: 2007-06-28
• Study Completion: 2008-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Any patient with pilonidal diseas

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
wound failure, time lost from work or school, analgesic requirements, recurrence rates	6 months

Secondary Outcome Measures

Name	Time	Method
infection rates, wound care requirements	6 months

Trial Locations

Locations (1)

St Francis Hospital; 🇺🇸 Hartford, Connecticut, United States