NCT03632954

Cytal® Wound Matrix and MicroMatrix® Wound Study

Use of Cytal® Wound Matrix and MicroMatrix® for the Management of Wounds

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study to assess the safety and efficacy of MicroMatrix® alone or in combination with Cytal® Wound Matrix on primary measures of wound healing.

Detailed description

A single-site, prospective, observational clinical study of Cytal® Wound Matrix alone or in combination with MicroMatrix® for the management of wounds. Up to 100 patients with multiple wound types including but not limited to, venous ulcers, diabetic foot ulcers, trauma wounds, and external surgical wounds will be treated either with Cytal® Wound Matrix alone or with Cytal® Wound Matrix and MicroMatrix® for wounds exceeding 3mm in depth. Wound healing efficacy, effect of treatment on patient-reported quality of life, complete wound management, wound-related adverse event, and wound pathology will be measured. The protocol defined patient follow-up is 12 months.

Conditions

• Wounds

Interventions

Type	Name	Description
DEVICE	ACell Arm	Cytal® Wound Matrix and/or MicroMatrix®

Timeline

• Start date: 2018-12-11
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2018-08-16
• Last updated: 2021-05-11
• Results posted: 2021-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study