The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case Series

Integra LifeSciences

Status: Terminated

Conditions: Pilonidal Disease

Treatments: Device: Wound Sheet Matrix 2-Layer and Powder Urinary Bladder Matrix

Study type: Observational

Funder types: Industry

Identifiers

NCT04041037

CR2018-001

Details and patient eligibility

About

A case series involving the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing.

Full description

This is a prospective case series examining the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing. Wound healing will be evaluated at 2 weeks, 6 weeks, and 3 months. If subjects heal prior to the 3 month visit, wound healing will be documented at that visit. A maximum of ten subjects will be included in this series.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has a clinical diagnosis of pilonidal disease.
2. Subject is being scheduled for surgical excision of pilonidal disease.
3. Subject is at least 18 years of age.
4. Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.
5. Subject is willing to provide written informed consent.

Exclusion criteria

1. Subject has a known allergy to porcine-based materials.
2. Subject is pregnant

Trial design