Trials / Terminated
TerminatedNCT04041037
The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case Series
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 2 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-03-26
- Primary completion
- 2019-08-30
- Completion
- 2019-11-05
- First posted
- 2019-08-01
- Last updated
- 2021-04-20
- Results posted
- 2020-07-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04041037. Inclusion in this directory is not an endorsement.