Oasis Donor Site Wounds Post-Market Study

Launched by COOK BIOTECH INCORPORATED · Sep 3, 2019

Keywords

ClinConnect Summary

The Oasis Donor Site Wounds Post-Market Study is a clinical trial aimed at testing a treatment called Oasis extracellular matrix (ECM) for healing donor site wounds. These are the areas where skin is taken from one part of the body to help heal another area. The study will take place in the United Kingdom and will involve about 40 patients aged 16 and older. It aims to show how safe and effective Oasis ECM is in helping these wounds heal properly.

To be eligible for the study, participants need to have a specific type of wound from where skin has been removed, and the wound should not be larger than 14 x 20 cm. However, certain conditions could prevent someone from joining, such as serious health issues that affect healing or allergies to the treatment materials. Those who participate can expect to receive the Oasis ECM treatment and will be monitored throughout the healing process. This study is important because it could help improve care for patients with donor site wounds, making healing faster and more effective.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 2. Has at least 24 hours to consent to study participation.
• Exclusion Criteria:
• • 1. Age \< 16 years
• 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