Oasis Donor Site Wounds Post-Market Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorCook Biotech Incorporated
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age < 16 years
Chronic inflammatory skin condition
Chronic liver failure
Chronic renal failure
Trial design
Design model
Parallel
Treatments tested in this trial
Oasis ECM
DeviceThe 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
Other interventionThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Oasis ECMActive comparator 1 intervention
Group B: Standard wound careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Donor site wound healing
To demonstrate the percentage of patients with wounds healed at day 14
Time frame
14 daysSecondary outcomes
1
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 days2
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 days3
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 months4
Adverse Events
Summary of adverse events reported
Time frame
up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov