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
Qualifiers
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
Treatments tested in this trial
- Oasis ECM
- standard wound care
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov