NCT00493493

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 28, 2007

Status Verified

June 1, 2007

First QC Date

June 27, 2007

Last Update Submit

June 27, 2007

Conditions

Pilonidal Sinus

Keywords

Cymetra

Outcome Measures

Primary Outcomes (1)

  • wound failure, time lost from work or school, analgesic requirements, recurrence rates

    6 months

Secondary Outcomes (1)

  • infection rates, wound care requirements

    6 months

Interventions

surgery (Pore Excision, Curettage, and Injection of Cymetra)PROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient with pilonidal diseas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Francis Hospital

Hartford, Connecticut, 06105, United States

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Surgical Procedures, OperativeCurettage

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • James J Matino, MD

    Surgical Group,PC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James J Matino, MD

CONTACT

860-249-8595jimanderin@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

January 1, 2007

Study Completion

June 1, 2008

Last Updated

June 28, 2007

Record last verified: 2007-06

Locations

US(1)