NCT04079348 Oasis Donor Site Wounds Post-Market Study
| NCT ID | NCT04079348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cook Biotech Incorporated |
| Condition | Surgical Wound |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2020-11-01 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04079348 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Surgical Wound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04079348 currently recruiting?
Yes, NCT04079348 is actively recruiting participants. Contact the research team at cgregory@rtix.com for enrollment information.
Where is the NCT04079348 trial being conducted?
This trial is being conducted at Manchester, United Kingdom.
Who is sponsoring the NCT04079348 clinical trial?
NCT04079348 is sponsored by Cook Biotech Incorporated. The trial plans to enroll 40 participants.