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

June 27, 2007 updated by: Matino, James, M.D.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Recruiting
        • St Francis Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient with pilonidal diseas

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
infection rates, wound care requirements
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matino, James, M.D.

Collaborators

LifeCell

Investigators

  • Principal Investigator: James J Matino, MD, Surgical Group,PC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

June 27, 2007

First Submitted That Met QC Criteria

June 27, 2007

First Posted (Estimate)

June 28, 2007

Study Record Updates

Last Update Posted (Estimate)

June 28, 2007

Last Update Submitted That Met QC Criteria

June 27, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pilonidal/Cymetra

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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