Actively Recruiting
Oasis Donor Site Wounds Post-Market Study
Led by Cook Biotech Incorporated · Updated on 2024-12-17
40
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 greater than 14 x 20 cm in size requiring placement of a covering material
- Has at least 24 hours to consent to study participation
- Age 16 years or older
You will not qualify if you...
- Age less than 16 years
- Has co-morbidities that impair wound healing including chronic inflammatory skin condition, chronic liver failure, chronic renal failure, blood-borne viruses (Hep B, Hep C, HIV), peripheral vascular disease, clinically significant anaemia, uncontrolled diabetes
- Requires use of the same harvest site again (re-cropping)
- History of radiation therapy to proposed donor site
- Chronic use of medications known to impair wound healing
- Chronic use of opioids or neuropathic pain agents
- Suspected cellulitis, osteomyelitis or septicaemia
- Undergoing haemodialysis
- Requires spinal or regional block
- On current anti-coagulant therapy
- Unable or unwilling to provide informed consent
- Unable or unwilling to comply with study follow-up schedule and procedures
- Currently participating in another investigational drug or device study (must have completed follow-up phase of prior study at least 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 infection at donor site and/or systemic infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
R
Rae Ritchie, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here