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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00493493
Recruitment Status : Unknown
Verified June 2007 by Matino, James, M.D..
Recruitment status was:  Recruiting
First Posted : June 28, 2007
Last Update Posted : June 28, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pilonidal Sinus Procedure: surgery (Pore Excision, Curettage, and Injection of Cymetra) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease
Study Start Date : January 2007
Estimated Study Completion Date : June 2008

Primary Outcome Measures :
  1. wound failure, time lost from work or school, analgesic requirements, recurrence rates [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. infection rates, wound care requirements [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Any patient with pilonidal diseas

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00493493

Contact: James J Matino, MD 860-249-8595

United States, Connecticut
St Francis Hospital Recruiting
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
Matino, James, M.D.
Principal Investigator: James J Matino, MD Surgical Group,PC Identifier: NCT00493493     History of Changes
Other Study ID Numbers: Pilonidal/Cymetra
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: June 28, 2007
Last Verified: June 2007

Keywords provided by Matino, James, M.D.:

Additional relevant MeSH terms:
Pilonidal Sinus