Back to resultsPore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease
Primary Purpose
Pilonidal Sinus
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
surgery (Pore Excision, Curettage, and Injection of Cymetra)
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus focused on measuring Cymetra
Eligibility Criteria
Inclusion Criteria:
- Any patient with pilonidal diseas
Sites / Locations
- St Francis HospitalRecruiting
Outcomes
Primary Outcome Measures
wound failure, time lost from work or school, analgesic requirements, recurrence rates
Secondary Outcome Measures
infection rates, wound care requirements
Full Information
NCT ID
NCT00493493
First Posted
June 27, 2007
Last Updated
June 27, 2007
Sponsor
Matino, James, M.D.
Collaborators
LifeCell
1. Study Identification
Unique Protocol Identification Number
NCT00493493
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Matino, James, M.D.
Collaborators
LifeCell
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
Keywords
Cymetra
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
surgery (Pore Excision, Curettage, and Injection of Cymetra)
Primary Outcome Measure Information:
Title
wound failure, time lost from work or school, analgesic requirements, recurrence rates
Time Frame
6 months
Secondary Outcome Measure Information:
Title
infection rates, wound care requirements
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient with pilonidal diseas
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James J Matino, MD
Phone
860-249-8595
Email
jimanderin@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James J Matino, MD
Organizational Affiliation
Surgical Group,PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Francis Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Pore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease
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