Pore Excision, Curettage, and Injection of Cymetra for Pi... | NCT00493493

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

NCT00493493

Sponsor

Matino, James, M.D.

Status

Unknown status

Last Update Posted

Jun 28, 2007Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Pilonidal Sinus

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Jun 2008Estimated

First Submitted Date

Jun 27, 2007

First Submission Date that Met QC Criteria

Jun 27, 2007

First Posted Date

Jun 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2007

Last Update Posted Date

Jun 28, 2007Estimated

Name	Class
LifeCell	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
surgery (Pore Excision, Curettage, and Injection of Cymetra)	Procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
infection rates, wound care requirements		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient with pilonidal diseas

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
James J Matino, MD	Contact	860-249-8595		jimanderin@yahoo.com

Overall Officials

Name	Affiliation	Role
James J Matino, MD	Surgical Group,PC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Francis Hospital	Recruiting	Hartford	Connecticut	06105	United States

ID	Term
D010864	Pilonidal Sinus

ID	Term
D003560	Cysts
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative
D003475	Curettage

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided