Status:
RECRUITING
Oasis Donor Site Wounds Post-Market Study
Lead Sponsor:
Cook Biotech Incorporated
Conditions:
Surgical Wound
Wound
Eligibility:
All Genders
16+ years
Phase:
NA
Brief 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 commercial...
Eligibility Criteria
Inclusion
- Has a split thickness skin graft (STSG) 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.
Exclusion
- Age \< 16 years
- Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as:
- 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
- Need for use of the same harvest site (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
- Patients undergoing haemodialysis
- Patients requiring spinal/regional block
- Patients on current anti-coagulant therapy
- Unable or unwilling to provide informed consent
- Unable or unwilling to comply with the study follow-up schedule, and procedures
- Simultaneously participating in another investigational drug or device study (patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrolment in this study)
- Allergy or hypersensitivity to materials that are porcine-based
- Cultural or religious objection to the use of pig or porcine products
- Known intolerance/allergy to standard wound care products
- Presence of a local infection at the donor site and/or systemic infection
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04079348
Start Date
November 1 2020
End Date
December 1 2025
Last Update
December 17 2024
Active Locations (1)
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1
Manchester University NHS Foundation Trust
Manchester, England, United Kingdom, M13 9WL