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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00493493
Enrollment
50
Registered
2007-06-28
Start date
2007-01-31
Completion date
2008-06-30
Last updated
2007-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal Sinus

Keywords

Cymetra

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.

Interventions

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

Sponsors

LifeCell
CollaboratorINDUSTRY
Matino, James, M.D.
Lead SponsorINDIV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Any patient with pilonidal diseas

Design outcomes

Primary

MeasureTime frame
wound failure, time lost from work or school, analgesic requirements, recurrence rates6 months

Secondary

MeasureTime frame
infection rates, wound care requirements6 months

Countries

United States

Contacts

Primary ContactJames J Matino, MD
jimanderin@yahoo.com860-249-8595

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026