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

NCT04041037 | Terminated Results FDA Device

• 1 other identifier: CR2018-001
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pilonidal Disease

Keywords

ACell; ACell MicroMatrix®; ACell Cytal® Wound Matrix; Urinary Bladder Matrix

Outcome Measures

Primary Outcomes (1)

• Rate of Wound Closure

  The study was terminated by Sponsor; no outcome measure data analyses were conducted.

  Up to 3 month visit

Other Outcomes (3)

• Visual Analogue Scale (VAS) for Pain

  Up to 3 month visit

• Katz Index of Independence in Activities of Daily Living (KATZ ADL)

  Up to 3 month visit

• Wound Related Adverse Events

  Up to 3 month visit

Interventions

Wound Sheet Matrix 2-Layer and Powder Urinary Bladder Matrix DEVICE

Porcine-derived extracellular matrix will be used in powder and 2-Layer wound sheet form in masses up to 1000 mg. Each product is intended for a one-time use only.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject has a clinical diagnosis of pilonidal disease.
• Subject is being scheduled for surgical excision of pilonidal disease.
• Subject is at least 18 years of age.
• 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.
• Subject is willing to provide written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (1)

AdventHealth Tampa

Tampa, Florida, 33613, United States

Location

Results Point of Contact

• Title: Allison Matthews
• Organization: Integra LifeSciences

allison.matthews@integralife.com

443-766-3869

Study Officials

• Haane Massarotti, MD

  Florida Hospital Tampa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: March 26, 2019
• Primary Completion: August 30, 2019
• Study Completion: November 5, 2019
• Last Updated: April 20, 2021
• Results First Posted: July 15, 2020

Record last verified: 2021-03

Locations

US (1)