Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2020-11-01
2025-12-31
Brief Summary
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About 40 patients (20 in each arm) over 16 years old will be involved in this study at one center in the United Kingdom.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
1\. 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.
TREATMENT
SINGLE
Study Groups
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Oasis ECM
The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application Oasis Extracellular Matrix to their donor site wound.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Has at least 24 hours to consent to study participation.
Exclusion Criteria
2. Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as:
1. Chronic inflammatory skin condition
2. Chronic liver failure
3. Chronic renal failure
4. Blood-borne viruses (Hep B, Hep C, HIV)
5. Peripheral vascular disease
6. Clinically significant anaemia
7. Uncontrolled diabetes
3. Need for use of the same harvest site (re-cropping)
4. History of radiation therapy to proposed donor site
5. Chronic use of medications known to impair wound healing
6. Chronic use of opioids or neuropathic pain agents
7. Suspected cellulitis, osteomyelitis or septicaemia
8. Patients undergoing haemodialysis
9. Patients requiring spinal/regional block
10. Patients on current anti-coagulant therapy
11. Unable or unwilling to provide informed consent
12. Unable or unwilling to comply with the study follow-up schedule, and procedures
13. 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)
14. Allergy or hypersensitivity to materials that are porcine-based
15. Cultural or religious objection to the use of pig or porcine products
16. Known intolerance/allergy to standard wound care products
17. Presence of a local infection at the donor site and/or systemic infection
16 Years
ALL
No
Sponsors
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Cook Biotech Incorporated
INDUSTRY
Responsible Party
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Locations
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Manchester University NHS Foundation Trust
Manchester, England, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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19-001
Identifier Type: -
Identifier Source: org_study_id