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

This study is currently recruiting participants.

Verified by Matino, James, M.D., June 2007

First Received: June 27, 2007 No Changes Posted

Sponsors and Collaborators:	Matino, James, M.D. LifeCell
Information provided by:	Matino, James, M.D.
ClinicalTrials.gov Identifier:	NCT00493493

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)

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

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

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

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

Cymetra

Study placed in the following topic categories:

Pilonidal Sinus
Cysts

Additional relevant MeSH terms:

Neoplasms
Pilonidal Sinus
Cysts

ClinicalTrials.gov processed this record on May 06, 2009