NCT04079348

Oasis Donor Site Wounds Post-Market Study

Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cook Biotech Incorporated · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety and performance of Oasis extracellular matrix (ECM) when used as a treatment for donor site wounds in the United Kingdom. Oasis ECM is commercially available for the treatment of partial and full-thickness skin wounds, including chronic wounds, wounds from trauma, and wounds that occur during surgery, such as donor site wounds. The ability of the Oasis ECM to promote the healing of donor site wounds will be evaluated in this study. About 40 patients (20 in each arm) over 16 years old will be involved in this study at one center in the United Kingdom.

Conditions

• Surgical Wound
• Wound
• Wounds and Injuries
• Wound Heal

Interventions

Type	Name	Description
DEVICE	Oasis ECM	The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application of Oasis Extracellular Matrix to their donor site wound.
OTHER	standard wound care	The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application of standard wound care to their donor site wound.

Timeline

• Start date: 2020-11-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2019-09-06
• Last updated: 2024-12-17

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study