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

Matino, James, M.D.

Status: Unknown

Conditions: Pilonidal Sinus

Treatments: Procedure: surgery (Pore Excision, Curettage, and Injection of Cymetra)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00493493

Pilonidal/Cymetra

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Any patient with pilonidal diseas

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)