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

NCT ID: NCT00493493

Last Updated: 2007-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Pilonidal Sinus

Keywords

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Cymetra

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Any patient with pilonidal diseas
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LifeCell

INDUSTRY

Sponsor Role collaborator

Matino, James, M.D.

INDIV

Sponsor Role lead

Principal Investigators

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James J Matino, MD

Role: PRINCIPAL_INVESTIGATOR

Surgical Group,PC

Locations

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St Francis Hospital

Hartford, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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James J Matino, MD

Role: CONTACT

Phone: 860-249-8595

Email: [email protected]

Other Identifiers

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Pilonidal/Cymetra

Identifier Type: -

Identifier Source: org_study_id