Actively Recruiting
Study Comparing Oasis Extracellular Matrix to Standard Care for Healing Donor Site Wounds in Patients Aged 16 and Older
Led by Cook Biotech Incorporated · Updated on 2024-12-17
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of Oasis extracellular matrix ECM as a treatment for donor site wounds in patients aged 16 years and older in the United Kingdom. This study aims to determine how well Oasis ECM promotes healing of these wounds, which can result from surgery, trauma, or chronic conditions. The trial involves about 40 participants divided into two groups to compare Oasis ECM with standard wound care. Participants will have a split-thickness skin graft harvested using a dermatome set at standard depth. One group will receive Oasis ECM applied to their donor site wound, while the other group will receive standard wound care. The study is randomized with two active treatment arms and includes a single-blind design. During the study, participants will be monitored for wound healing over 14 days, including assessing pain levels, analgesic use, and patient-reported pain. Cosmetic outcomes will be evaluated using the POSAS scale up to six months, along with tracking any adverse events. The study involves follow-up visits and assessments to measure safety and effectiveness of the treatments over time.
CONDITIONS
Brief Title
Oasis Donor Site Wounds Post-Market Study
Research Team
C
Carina Gregory, MS
R
Rae Ritchie, PhD
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