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

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ClinicalTrials.gov Identifier: NCT04041037
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
ACell Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Pilonidal Disease 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 Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case Series
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 31, 2020

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Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Rate of Wound Closure [ Time Frame: Up to 3 month visit ]
    Percentage of wound closure


Other Outcome Measures:
  1. Visual Analogue Scale (VAS) for Pain [ Time Frame: Up to 3 month visit ]
    VAS is a psychometric response scale that measures subjective characteristics or attitudes regarding perceived pain levels from participants. Participants are asked to draw a line on a 10cm horizontal line indicating what their current pain level would be. The distance between the start of the horizontal line to the vertical line is calculated in cm with a higher score (10cm) indicating a greater pain intensity.

  2. Katz Index of Independence in Activities of Daily Living (KATZ ADL) [ Time Frame: Up to 3 month visit ]
    The Katz ADL is a 6-item questionnaire measuring independence in activities of daily living such as bathing, dressing, toileting, transfers, feeding, and continence. Each item is dichotomized as either having a score of zero (i.e dependence) or one (i.e. independence). An overall score of 6 indicates full function and an overall score of 2 or less indicates severe functional impairment

  3. Wound Related Adverse Events [ Time Frame: Up to 3 month visit ]
    Number and type of wound related adverse events as recorded on adverse event case report forms


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041037


Contacts
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Contact: Melinda Wooten 443-283-2786 melindawooten@acell.com
Contact: Tejal Gambhir 443-283-7961 tejalgambhir@acell.com

Locations
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United States, Florida
AdventHealth Tampa Recruiting
Tampa, Florida, United States, 33613
Contact: Christopher Carr, RN    813-615-7068    Christopher.Carr@AdventHealth.com   
Principal Investigator: Haane Massarotti, MD         
Sub-Investigator: Allen Chudzinski, MD         
Sponsors and Collaborators
ACell Inc.
Investigators
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Study Director: Elizabeth Smith ACell Inc.
More Information
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Responsible Party: ACell Inc.
ClinicalTrials.gov Identifier: NCT04041037     History of Changes
Other Study ID Numbers: CR2018-001
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ACell Inc.:
ACell
ACell MicroMatrix®
ACell Cytal® Wound Matrix
Urinary Bladder Matrix
Additional relevant MeSH terms:
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Wounds and Injuries