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


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Open (Enrolling)
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Pilonidal Sinus

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Trial Information

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


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.


Inclusion Criteria:



- Any patient with pilonidal diseas

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 months

Principal Investigator

James J Matino, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Surgical Group,PC

Authority:

United States: Institutional Review Board

Study ID:

Pilonidal/Cymetra

NCT ID:

NCT00493493

Start Date:

January 2007

Completion Date:

June 2008

Related Keywords:

  • Pilonidal Sinus
  • Cymetra
  • Pilonidal Sinus

Name

Location

St Francis HospitalHartford, Connecticut  06105