NCT03632031

Treatment of Wounds Using Oasis® ECM

Treatment of Wounds Using Oasis® Extracellular Matrix in the Community Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Cook Biotech Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for donor site wounds in the community setting in the United Kingdom.

Detailed description

This prospective randomized controlled clinical study is being performed to evaluate the safety and performance of OASIS Extracellular Matrix when used as a treatment for donor site wounds as compared to standard wound care. This study will consent and treat up to 40 patients with 20 patients assigned to the OASIS treatment group and 20 patients assigned to the standard wound care treatment group.

Conditions

• Non-healing Wound

Interventions

Type	Name	Description
DEVICE	Oasis Extracellular Matrix	Patients will receive OASIS Extracellular Matrix according to the Instruction for Use
OTHER	Standard Care (in control arm)	Donor site will be treated with standard care.

Timeline

• Start date: 2021-03-01
• Primary completion: 2025-03-01
• Completion: 2025-09-26
• First posted: 2018-08-15
• Last updated: 2026-02-18

Locations

2 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated device study