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RECRUITING
NCT04079348
NA

Oasis Donor Site Wounds Post-Market Study

Sponsor: Cook Biotech Incorporated

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-11-01

Completion Date

2025-12

Last Updated

2024-12-17

Healthy Volunteers

No

Interventions

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.

Locations (1)

Manchester University NHS Foundation Trust

Manchester, England, United Kingdom