NCT03723603

An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds

A Case Series Evaluating a Fibrillar Collagen Powder Dressing to Treat Chronic, Stalled Lower-extremity Wounds

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Medline Industries · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.

Conditions

• Wound

Interventions

Type	Name	Description
DEVICE	Fibrillar collagen powder dressing	A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types.

Timeline

• Start date: 2018-11-09
• Primary completion: 2019-06-04
• Completion: 2019-07-30
• First posted: 2018-10-29
• Last updated: 2020-03-18
• Results posted: 2020-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study