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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by Matino, James, M.D..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00493493
First Posted: June 28, 2007
Last Update Posted: June 28, 2007
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.
Collaborator:
LifeCell
Information provided by:
Matino, James, M.D.
  Purpose
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
Pilonidal Sinus Procedure: surgery (Pore Excision, Curettage, and Injection of Cymetra)

Study Type: Interventional
Study Design: 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

Further study details as provided by Matino, James, M.D.:

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

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

Estimated Enrollment: 50
Study Start Date: January 2007
Estimated Study Completion Date: June 2008
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Any patient with pilonidal diseas
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00493493


Contacts
Contact: James J Matino, MD 860-249-8595 jimanderin@yahoo.com

Locations
United States, Connecticut
St Francis Hospital Recruiting
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
Matino, James, M.D.
LifeCell
Investigators
Principal Investigator: James J Matino, MD Surgical Group,PC
  More Information

ClinicalTrials.gov Identifier: NCT00493493     History of Changes
Other Study ID Numbers: Pilonidal/Cymetra
First Submitted: June 27, 2007
First Posted: June 28, 2007
Last Update Posted: June 28, 2007
Last Verified: June 2007

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

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms