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

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.

Study Overview

• Status: Terminated
• Conditions: Pilonidal Disease
• Intervention / Treatment: Device: Wound Sheet Matrix 2-Layer and Powder Urinary Bladder Matrix

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33613
      • AdventHealth Tampa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from the medical offices of the Principal Investigator, Dr. Massarotti, and CO-Investigator, Dr. Chudzinski.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Wound Closure	The study was terminated by Sponsor; no outcome measure data analyses were conducted.	Up to 3 month visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) for Pain	The study was terminated by Sponsor; no outcome measure data analyses were conducted.	Up to 3 month visit
Katz Index of Independence in Activities of Daily Living (KATZ ADL)	The study was terminated by Sponsor; no outcome measure data analyses were conducted.	Up to 3 month visit
Wound Related Adverse Events	Number and type of wound related adverse events as recorded on adverse event case report forms	Up to 3 month visit

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Principal Investigator: Haane Massarotti, MD, Florida Hospital Tampa

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): November 5, 2019

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: ACell; ACell MicroMatrix®; Urinary Bladder Matrix; ACell Cytal® Wound Matrix
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CR2018-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No