Actively Recruiting
Feasibility Study Comparing Oasis Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds
Led by Cook Biotech Incorporated · Updated on 2024-12-17
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a split thickness skin graft donor site wound no larger than 14 x 20 cm requiring covering
- Has at least 24 hours to consent to study participation
- Age 16 years or older
You will not qualify if you...
- Age under 16 years
- Co-morbidities impairing wound healing, including chronic inflammatory skin conditions, chronic liver or renal failure, blood-borne viruses (Hep B, Hep C, HIV), peripheral vascular disease, significant anemia, or uncontrolled diabetes
- Need for use of the same harvest site again (re-cropping)
- History of radiation therapy to the donor site
- Chronic use of medications impairing wound healing
- Chronic use of opioids or neuropathic pain agents
- Suspected cellulitis, osteomyelitis, or septicaemia
- Undergoing haemodialysis
- Requiring spinal or regional block
- Current anti-coagulant therapy
- Unable or unwilling to provide informed consent
- Unable or unwilling to comply with study follow-up and procedures
- Participating in another investigational drug or device study within 30 days prior
- Allergy or hypersensitivity to porcine-based materials
- Cultural or religious objection to pig or porcine products
- Known intolerance or allergy to standard wound care products
- Presence of local or systemic infection at the donor site or elsewhere
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants undergo harvesting of a split-thickness skin graft and receive either Oasis Extracellular Matrix or standard wound care applied to their donor site wound.
Daily or regular visits to assess wound healing and pain
Duration - Up to 6 months
Participants are monitored for cosmetic outcome, adverse events, and overall wound healing progress.
Periodic visits during the 6 months following treatment
Trial Site Locations
Total: 1 location
1
Manchester University NHS Foundation Trust
Manchester, England, United Kingdom, M13 9WL
Actively Recruiting
Research Team
C
Carina Gregory, MS
R
Rae Ritchie, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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