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Recruiting Not applicable

Oasis Donor Site Wounds Post-Market Study

NCT04079348 · tracked via the Priya Life Science UK tracker
Sponsor
Cook Biotech Incorporated
Phase
Not applicable
Started
2020-11-01
Last updated
2024-12-17

Condition(s) studied

Surgical WoundWoundWounds and InjuriesWound Heal

Investigational drug(s) / intervention(s)

Oasis ECMstandard wound care

Oasis ECM: 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.

standard wound care: 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.

Study 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

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Donor site wound healing — 14 days
    To demonstrate the percentage of patients with wounds healed at day 14

Trial sites (1)

FacilityCityRegionStatus
Manchester University NHS Foundation Trust Manchester England Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04079348 on ClinicalTrials.gov ↗ ← All trials in the UK