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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Matino, James, M.D..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
LifeCell
Information provided by:
Matino, James, M.D.
ClinicalTrials.gov Identifier:
NCT00493493
First received: June 27, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient with pilonidal diseas
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00493493     History of Changes
Other Study ID Numbers: Pilonidal/Cymetra
Study First Received: June 27, 2007
Last Updated: June 27, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms

ClinicalTrials.gov processed this record on August 18, 2014