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

Terminated

• Conditions: Pilonidal Disease

• Registration Number: NCT04041037
• Lead Sponsor: Integra LifeSciences Corporation

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.

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 Timeline

• Study Start: 2019-03-26
• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-08-01
• Primary Completion: 2019-08-30
• Study Completion: 2019-11-05
• Results First Submitted: 2020-06-29
• Results First Submitted QC: 2020-06-29
• Results First Posted: 2020-07-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

AdventHealth Tampa; 🇺🇸 Tampa, Florida, United States