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

Pilonidal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04041037
• Other study ID #: CR2018-001
• Status: Terminated
• Start date: March 26, 2019
• Est. completion date: November 5, 2019

Study information

• Verified date: March 2021
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 5, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pilonidal Disease
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	AdventHealth Tampa	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analogue Scale (VAS) for Pain	The study was terminated by Sponsor; no outcome measure data analyses were conducted.	Up to 3 month visit
Other	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
Other	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
Primary	Rate of Wound Closure	The study was terminated by Sponsor; no outcome measure data analyses were conducted.	Up to 3 month visit