Pore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 27, 2007

Last Updated Date

June 27, 2007

Start Date ^†

January 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

infection rates, wound care requirements [ Time Frame: 6 months ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease

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 Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Pilonidal Sinus

Intervention ^†

Procedure: surgery (Pore Excision, Curettage, and Injection of Cymetra)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

June 2008

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria: - Any patient with pilonidal diseas

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Contact: James J Matino, MD

860-249-8595

jimanderin@yahoo.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00493493

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Matino, James, M.D.

Collaborators ^††

LifeCell

Investigators ^†

Principal Investigator:

James J Matino, MD

Surgical Group,PC

Information Provided By

Matino, James, M.D.

Verification Date

June 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.