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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
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.
Manchester University NHS Foundation Trust
Manchester, England, United Kingdom
RECRUITINGDonor site wound healing
To demonstrate the percentage of patients with wounds healed at day 14
Time frame: 14 days
Amount of pain, analgesic usage
Patient will record daily usage of analgesics in a diary, daily, over the first 14 days post-treatment
Time frame: 14 days
Amount of pain, patient perceived
Patient will use the Visual Analog Score (VAS) to record pain in a diary, daily, over the first 14 days post-treatment.
Time frame: 14 days
Cosmetic Outcome utilizing POSAS
Cosmesis of the donor site wound will be assessed 3- and 6-months post-treatment by using the Patient and Observer Scar Assessment Scale (POSAS).
Time frame: up to 6 months
Adverse Events
Summary of adverse events reported
Time frame: up to 6 months
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