NCT06629506

MicroMatrix® Flex in Tunneling Wounds

Prospective Evaluation of MicroMatrix® Flex in Wounds Complicated by Tunneling and Undermining

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.

Detailed description

The purpose of this study is to evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features. Prospective data will be collected to assess the rate of wound area/volume reduction (progression toward closure) and post-operative complications at 12 weeks, and rate of skin graft take, when applicable, up to 16 weeks follow-up.

Conditions

• Pressure Injury
• Venous Ulcer
• Necrotizing Soft Tissue Infection
• Diabetic Ulcers
• Draining Wound

Interventions

Type	Name	Description
DEVICE	MicroMatrix® Flex	MicroMatrix® Flex is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), draining wounds. The device is intended for one-time use.
DEVICE	MicroMatrix® UBM Particulate	MicroMatrix® UBM Particulate is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. The device is intended for one-time use.
DEVICE	Cytal® Wound Matrix 2-Layer	Cytal® Wound Matrix is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. The device is intended for one-time use.

Timeline

• Start date: 2024-12-12
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2024-10-08
• Last updated: 2026-03-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study